Every finding on record at Pinnacle Health Corporation

The following reflects the findings of the California Department of Public Health during the concurrent EMERGENCY PREPAREDNESS and PARTIAL EXTENDED RECERTIFICATION surveys. Representing the California Department of Public Health: Surveyors 31929, HFEN and 39210, HFEN. The survey team entered the hospice on 6/14/23 at 1000 hours. The survey team reviewed twelve active and five closed clinical records. GLOSSARY OF ABBREVIATIONS: DPCS: Director Patients Care Services P&P: Policy & Procedure

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure the agency's comprehensive emergency preparedness program's facility and community-based risk assessment, included strategies for addressing the emergency events identified by the risk assessment. This created the potential risk of not meeting the health, safety, and security needs of their staff and patient population during an emergency or disaster situation. Findings: Review of the agency's P&P on emergency preparedness and plan was conducted on 6/23/23. The agency's P&P tiled Emergency Management Plan (undated) showed the facility and community hazards assessments were completed. However, the agency's emergency preparedness plan failed to include strategies for addressing hazards or emergency events identified by the facility risk assessments. On 6/23/23 at 1358 hours, an interview and concurrent record review was conducted with the Administrator. The Administrator was informed and acknowledged the findings.

EP Program Patient Population CFR(s): 484.102(a)(3) §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.542(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.** *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following: (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. *NOTE: ["Persons at risk" does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.] This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure the agency's comprehensive emergency preparedness program addressed their patient population, including the type of services the agency was able to provide in an emergency event. This created the potential risk of not meeting the health, safety, and security needs of their staff and patient population during an emergency or disaster situations. Findings: Review of the agency's P&P on emergency preparedness plan was conducted on 6/23/23. The agency's P&P tiled Emergency Management Plan (undated) showed the facility and community hazards assessments were completed. However, the agency's emergency preparedness plan failed to address the patient population, including the types of services the agency is able to provide in the event of an emergency, continuity of operations, and delegations of authority and succession plans. On 6/23/23 at 1358 hours, an interview and concurrent record review was conducted with the Administrator. The Administrator was informed and acknowledged the findings.

Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility's needs in the event of an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness plan included a process for cooperation and collaboration with the State and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, creating the risk of not providing an appropriate, consistent, and quality care to the patients. Findings: Review of the agency's emergency preparedness plan was conducted on 6/23/23. The agency's P&P tiled Emergency Management Plan (undated) showed the Executive Director or Administrator will initiate the communication plan to notify personnel and community authorities. However, the agency's emergency preparedness plan did not include a process for cooperation and collaboration with tribal, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. On 6/23/23 at 1358 hours, an interview and concurrent record review was conducted with the Administrator. The Administrator was informed and acknowledged the findings.

Homebound HHA/Hospice Inform EP Officials CFR(s): 484.102(b)(2) §418.113(b)(2), §460.84(b)(4), §484.102(b)(2) [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] *[For homebound Hospice at §418.113(b)(2), PACE at §460.84(b)(4), and HHAs at §484.102(b)(2):] The procedures to inform State and local emergency preparedness officials about [homebound Hospice, PACE or HHA] patients in need of evacuation from their residences at any time due to an emergency situation based on the patient's medical and psychiatric condition and home environment. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness plan included the procedure to inform State and local emergency preparedness officials about the patients in need of evacuation during a disaster or emergency situation, creating the risk of not providing an appropriate, consistent, and quality care to the patients. Findings: Review of the agency's emergency preparedness plan was conducted on 6/23/23. The agency's P&P tiled Emergency Management Plan (undated) showed the Executive Director or Administrator will initiate the communication plan to notify personnel and community authorities. However, the agency's emergency preparedness plan did not include a procedure for informing the State and local emergency preparedness officials about the patients in need of evacuation from their residence during an emergency situation based on the patient's medical and psychiatric condition and home environment. On 6/23/23 at 1558 hours, an interview and concurrent record review was conducted with the Administrator. The Administrator was informed and acknowledged the findings.

HHA- Procedures for Follow up Staff/Pts. CFR(s): 484.102(b)(3) §484.102(b)(3) Condition of Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness plan included the procedure to inform the State and local emergency preparedness officials about any on-duty staff and patients they were unable to contact. Findings: Review of the agency's emergency preparedness plan was conducted on 6/23/23. The agency's P&P tiled Emergency Management Plan (undated) showed the Executive Director or Administrator will initiate the communication plan to notify personnel and community authorities. However, the agency's Emergency Preparedness Plan P&P did not include the procedures to follow up with any on-duty staff or patients they were- unable to contact, or procedures to communicate with state and local officials of any on duty staff or patients they were unable to contact. On 6/23/23 at 1358 hours, an interview and concurrent record review was conducted with the Administrator. The Administrator was informed and acknowledged the findings.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure the emergency preparedness communication plan included the updated names and contact information of the agency's staff, entities under agreement, and the patients' physicians. This failure had the potential to negatively impact the patients' care needs during an emergency event. Findings: Review of the agency's emergency preparedness plan was conducted on 6/23/23. Review of the agency's Emergency Management Plan (undated) showed in the event of a prolonged emergency situation, the Executive Director/ Administrator or designee will initiate the phone communication plan to notify personnel and community authorities. However, the agency's emergency preparedness plan did not include an updated list of names and contact information of the agency's staff, entities under agreement, and the patients' physicians. On 6/23/23 at 1358 hours, an interview and concurrent record review was conducted with Administrator. The Administrator was informed and acknowledged the findings.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness communication plan included the contact information for federal, state, tribal, and regional emergency management agencies. This failure had the potential to negatively impact the patients' care needs during the emergency events. Findings: Review of the agency's emergency preparedness plan was conducted on 6/23/23. Review of the agency's Emergency Management Plan (undated) showed in the event of a prolonged emergency situation, the Executive Director/ Administrator or designee will initiate the phone communication plan to notify personnel and community authorities. However, the agency's emergency preparedness plan did not include the contact information of the Federal, State, tribal, and regional emergency management agencies. On 6/23/23 at 1358 hours, an interview and concurrent record review was conducted with Administrator. The Administrator was informed and acknowledged the findings.

Primary/Alternate Means for Communication CFR(s): 484.102(c)(3) §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.542(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID's staff, Federal, State, tribal, regional, and local emergency management agencies. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure the emergency preparedness communication plan included primary and alternate means for communicating with federal, state, tribal, regional, and local emergency management agencies. This failure had the potential to negatively impact the patients' care needs during the emergency events. Findings: Review of the agency's emergency preparedness plan was conducted on 6/23/23. Review of the agency's Emergency Management Plan (undated) showed in the event of a prolonged emergency situation, the Executive Director/ Administrator or designee will initiate the phone communication plan to notify personnel and community authorities. However, the agency's emergency preparedness plan did not include the alternate means of communicating with the federal, state, tribal, and regional emergency management agencies. On 6/23/23 at 1358 hours, an interview and concurrent record review was conducted with Administrator. The Administrator was informed and acknowledged the findings.

Information on Occupancy/Needs CFR(s): 484.102(c)(6) §403.748(c)(7), §416.54(c)(7), §418.113(c)(7) §441.184(c)(7), §482.15(c)(7), §460.84(c)(7), §483.73(c)(7), §483.475(c)(7), §484.102(c)(6), §485.68(c)(5), §485.68(c)(5), §485.727(c)(5), §485.542(c)(7), §485.625(c)(7), §485.920(c)(7), §491.12(c)(5), §494.62(c)(7). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (7) [(5) or (6)] A means of providing information about the [facility's] occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For ASCs at 416.54(c)]: (7) A means of providing information about the ASC's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For Inpatient Hospice at §418.113(c):] (7) A means of providing information about the hospice's inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness communication plan included the means of providing information about the agency to appropriate authorities and personnel. This failure had the potential to negatively impact the patients' care needs during the emergency events. Findings: Review of the agency's emergency preparedness plan was conducted on 6/23/23. Review of the agency's Emergency Management Plan (undated) showed in the event of a prolonged emergency situation, the Executive Director/ Administrator or designee will initiate the phone communication plan to notify personnel and community authorities. However, the agency's emergency preparedness plan did not include the means of providing information about the agency's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Commander, or designee. On 6/23/23 at 1358 hours, an interview and concurrent record review was conducted with Administrator. The Administrator was informed and acknowledged the findings.

The following reflects the findings of the California Department of Public Health during the concurrent PARTIAL EXTENDED RECERTIFICATION and EMERGENCY PREPAREDNESS surveys. Representing the California Department of Public Health: Surveyors 31929, HFEN and 39210, HFEN. The survey team entered the HHA on 6/14/23 at 1000 hours. The survey team reviewed twelve active and five closed clinical records. GLOSSARY OF ABBREVIATIONS AND BRIEF DEFINITIONS: ADL: activities of daily living AROM: active range of motion BID: twice a day BM: bowel movement CDC: Centers for Disease Control and Prevention CHHA: Certified Home Health Aide cm: centimeter COPD: Chronic obstructive pulmonary disease (a group of diseases that cause airflow blockage and breathing-related problems) COVID 19: an infectious disease caused by the SARS-CoV-2 virus DPCS: Director of Patient Care Services gm: gram(s) GERD: gastroesophageal reflux disease (digestive disorder that affects the ring of muscle between your esophagus and your stomach) GI: Gastrointestinal GU: Genitourinary HHA: Home Health Agency HS: bedtime LVN: Licensed Vocational Nurse mcg: microgram(s) mg: milligram(s) ml: milliliter(s) NS: normal saline OASIS: Outcome and Assessment Information Set OT: Occupational Therapy/Therapist PCG: Patient Care Giver P&P: policy and procedure pneumonia: infection that affects one or both lungs. PO: by mouth POC: Plan of Care PRN: As needed PT: Physical Therapy/Therapist Q: Every QA: Quality Assurance QAPI: Quality Assurance and Performance Improvement QD: Every day PROM: passive range of motion PTA: Physical Therapy Assistant/s ROM: range of motion RN: Registered Nurse SN: Skilled Nurse SOC: Start of Care Stage 2 pressure injury: Partial-thickness loss of skin with exposed dermis. The wound bed is viable, pink or red, moist, and may also present as an intact or ruptured serum-filled blister. UTI: Urinary Tract Infection W: week

Investigate complaints made by patient CFR(s): 484.50(e)(1)(i) (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: This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the complaints for one nonsampled patient (Patient A) was thoroughly investigated, creating the risk not providing quality of care and services to this patient. Findings: Review of the agency’s P&P titled Complaint/Grievance Process (undated) showed the organization's personnel receiving the complaint will discuss verbally and in writing the grievance with the DPCS within five days of the alleged grievance. The DPCS will investigate the grievance within five days after receipt of such grievance and will make every effort to resolve the grievance to the patient’s satisfaction. Response to the patient will occur within 10 days of receipt. a. The Grievance/Report form dated 9/3/21, showed there was a call to report the PTA "is only spending 10 to 15 mins per session" with the patient. Documentation included "seems to do some bed exercises and only walks from bed to chair." Documentation showed the family member wanted the patent to have the therapy “to the fall extent is needed.” Documentation showed OT did a better job. The form showed under the action taken, a follow up was conducted with the family member. Documentation showed another person would take over the therapy sessions and extend the therapy by the number of days the PTA did not stay long. Documentation also showed the family member was satisfied with the outcome at that time. * However, there was no documented evidence of a thorough investigation by interviewing the PTA and/or other patients who received service from the PTA, if there was any regarding the above grievance. On 6/27/23 at 1042 hours, an interview and concurrent record review was conducted with the Administrator. She was informed of the findings.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the initial comprehensive assessments were completed in a timely manner, consistent with the patient's immediate needs for 14 of 17 sampled patients (Patients 1, 2, 3, 4, 5, 9, 10, 11, 12, 13, 14, 15, 16, and 17), creating the risk of not identifying and addressing the care needs timely for these patients. Findings: Review of the clinical records for Patients 1, 2, 3, 4, 5, 9, 10, 11, 12, 14, 15, 16, and 17, showed no documented evidence the comprehensive assessments were completed for these patients in a timely manner. For example: 1. Review of Patient 1's clinical record was initiated on 6/22/23. The clinical record showed the SOC was 4/16/23. The patient was certified for home health services during the period from 4/16/23 to 6/14/23. The SOC assessment dated 4/16/23, showed no documented evidence the patient’s handgrips, pupils, capillary refill, and sleep/rest were assessed. In addition, the medication profile showed the patient was on aripiprazole (antipsychotic) 30 mg one half tablet PO BID and venlafaxine (antidepressant) extended release 75 mg three capsules PO QD. However, the SOC assessment showed the information for psychotropic drug use was blank. On 6/27/23 at 1100 hours, an interview and concurrent record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed and acknowledged the findings. 2. Review of Patient 4’s clinical record was initiated on 6/22/23. The clinical record showed the SOC was 3/18/23. The patient was certified for home health services during the period from 5/17/23 to 7/15/23. The SOC assessment dated 3/21/23, showed no documented evidence the patient’s handgrips were assessed. In addition, the medication profile showed the patient was on sertraline (antidepressant) 50 mg one tablet PO BID and quetiapine (antipsychotic) 25 mg one tablet PO Q HS. However, the start of care assessment showed the information for psychotropic drug use was blank. On 6/27/23 at 1106 hours, an interview and concurrent record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed and acknowledged the findings.

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 record review, the agency failed to ensure the medication profiles were updated to reflect the patients' current medications and included specific indications and parameters for their use for seven of 17 sampled patients (Patients 2, 3, 6, 8, 9, 11, and 12). These failures created the risk for the patients not receiving the appropriate care and services necessary to improve the patients' health conditions. X. Review of Patient 2's clinical record was initiated on 6/20/23. The clinical record showed the SOC was 11/19/22. The patient was certified for home health services during the certification periods from 3/19/23 to 5/17/23 and 5/18/23 to 7/16/23. The medication profile showed the patient’s medications included Tylenol 325 mg, two tablets by mouth every six hours as needed for fever or mild pain and Pyridium 200 mg (a medication used to relieve urinary pain and discomfort) PO every eight hoursm as needed for pain. * However, the physician's order did not include when to administer the above medications which were for the same indication for pain. On 6/27/23 at 0930 hours, an interview and concurrent clinical record review was conducted with LVN 1. LVN 1 was informed and acknowledged the finding. XX. Review of Patient 3's clinical record was initiated on 6/21/23. The clinical record showed the SOC was 1/12/23. The patient was certified for home health services during the certification periods from 1/12/23 to 3/12/23, 3/13/23 to 5/11/23, and 5/12/23 to 7/10/23. The medication profile showed the patient’s medications included Tylenol 325 mg, two tablets by mouth every six hours as needed for pain and Tramadol 50 mg one tablet three times a day as needed for pain. * However, the physician's order did not include when to administer the above medications which were for the same indication for pain. On 6/23/23 at 1108 hours, an interview and concurrent clinical record review was conducted with LVN 1. LVN 1 was informed and acknowledged the finding. XXX. Review of Patient 6's clinical record was initiated on 6/19/23. The clinical record showed the SOC was 5/9/2019. The patient was certified for home health services during the certification periods from 2/17/23 to 4/17/23 and 4/18/23 to 6/26/23. The medication profile, for the certification period from 4/18/23 to 6/16/23, included the following medications: Xanax 0.25 mg (a medication used to treat anxiety) one tablet under the tongue twice daily as needed for dysphagia associated with extreme anxiety; Tramadol 50 mg (a medication used to treat pain) one tablet PO every six to eight hours for pain, Levothyroxine 150 mcg (a medication used to treat underactive thyroid gland) one tablet PO daily; Potassium Chloride 20 mEq one tablet, PO daily; Omeprazole 20 mg one tablet PO daily; Furosemide 40 mg (a medication used to treat fluid retention) one tablet PO daily; Vitamin C 500 mg, one tablet, PO daily; Iron 65 mg, one capsule PO daily; Vasculera 650 mg (a prescribed dietary supplement used for chronic venous insufficiency) one capsule, PO daily; Topiramate 200 mg (a medication used to manage epilepsy) two tablets, PO at night; and Zyrtec 10 mg one capsule PO twice daily as needed for seasonal allergies. A joint home visit was conducted with RN 2 on 6/16/23 at 1250 hours, to Patient 6's home. Review of the medications with RN 2 and the family member showed the following: - Patient 6 was no longer taking Xanax 0.25 mg (a medication used to treat anxiety) one tablet under the tongue twice daily as needed for dysphagia associated with extreme anxiety; Tramadol 50 mg (a medication used to treat pain) one tablet PO every six to eight hours for pain; Potassium Chloride 20 mEq one tablet, PO daily; Omeprazole 20 mg one tablet PO daily; Furosemide 40 mg (a medication used to treat fluid retention) one tablet PO daily; Vitamin C 500 mg, one tablet, PO daily; Iron 65 mg, one capsule PO daily; Vasculera 650 mg (a prescribed dietary supplement used for chronic venous insufficiency) one capsule, PO daily; Topiramate 200 mg (a medication used to manage epilepsy) two tablets, PO at night; and Zyrtec 10 mg one capsule PO twice daily as needed for seasonal allergies. - Levothyroxine 100 mcg, one tablet, PO daily. On 6/16/23 at 1330 hours, an interview and concurrent record review was conducted with RN 2 and was informed of the finding. RN 2 stated they are suppose to review the patient's medications at each visit. On 6/27/23 at 1108 hours, an interview and concurrent record review was conducted with LVN 1. LVN 1 was informed and acknowledged the finding. XXXX. Review of Patient 8's clinical record was initiated on 6/19/23. The clinical record showed the SOC was 3/1/23. The patient was certified for home health services during the certification periods from 3/1/23 to 4/29/23 and 4/30/23 to 6/28/23. Review of Patient 8's medication profile included Biscodyl 5 mg one tablet PO daily as needed for constipation; Milk of magnesia 30ml, PO daily as needed for constipation; and Senna 8.6 mg two tablets PO daily as needed for constipation. *However, the physician's order did not include when to administer the above medications which were for the same indication for constipation. On 6/27/23 at 1140 hours, an interview and concurrent clinical record review was conducted with LVN 1. LVN 1 was informed and acknowledged the above findings. XXXXXa. Review of Patient 9's clinical record was initiated on 6/15/23. The clinical record showed the SOC was 5/13/23. The patient was certified for home health services during the period from 5/13/23 to 7/11/23. The medication profile, for the certification period from 5/7/23 to 7/5/23, included the following medications: Tramadol 50mg one tablet, PO, every 8 hours as needed for pain; Acetaminophen 20.5 ml PO every four hours as needed for pain; Gabapentin 100 mg (a medication used to treat nerve pain), one tablet PO, twice a day; Lisinopril 5mg (a medication used to treat blood pressure), one table, PO daily; and Milk of Magnesia 30 ml PO daily as needed for constipation. A joint home visit with the PT 1 was conducted on 6/15/23 at 1300, to Patient 9's home. The following was observed: Review of the medications with PT 1 showed a list of current medications which included the following: - Tramadol 50 mg, one tablet PO every 8 hours as needed for pain, with a handwritten note of moderate to severe; - Acetaminophen 20.5 ml PO every four hours as needed for pain, crossed out and a handwritten note of change to oral tablet, and Acetaminophen 325 mg, two tablets PO, every 6 hours as needed for pain mild to moderate; - Gabapentin 100 mg (a medication used to treat nerve pain), one tablet PO, twice a day with a handwritten note of additional two capsules at bedtime and Gabapentin 100 mg oral capsule, two capsule at bedtime; - Lisinopril 5mg, one tablet PO daily, with a handwritten note to hold if SBP is less than 110; - Milk of Magnesia 400mg/ 5ml PO daily as needed for constipation; - A handwritten note of Amantadine HCl 100 mg, one capsule PO daily; - A handwritten note of Calcium 600 + Vitamin D3 600 mg - 400 unit, one tablet PO, two times a day; - A handwritten note of Acyclovir 400 mg one tablet PO daily. On 6/15/23 at 1300 hours, an interview and concurrent clinical record review was conducted with PT 1. PT 1 was informed and acknowledged the above findings. On 6/27/23 at 1056 hours, an interview and concurrent clinical record review was conducted with LVN 1. LVN 1 was informed and acknowledged the above findings. b. Review of Patient 9's medication profile included Dulcolax 10 mg rectal suppository apply rectally daily as needed for constipation; Milk of magnesia 30ml, PO daily as needed for constipation; and Fleet enema apply rectally daily as needed for constipation. *However, the physician's order did not include when to administer the above medications which were for the same indication for constipation. On 6/27/23 at 1056 hours, an interview and concurrent clinical record review was conducted with LVN 1. LVN 1 was informed and acknowledged the above findings. 1. Review of Patient 11's clinical record was initiated on 6/15/23. The clinical record showed the SOC was 1/13/23. The patient was certified for home health services during the period from 5/13/23 to 7/11/23. The medication profile, for the certification period from 5/13/23 to 7/11/23, included the following medications: saline enema (laxative) one to two times per day PRN for constipation, Dulcolax (laxative) 10 mg rectal suppository once a day PRN for constipation, lactulose (laxative) 10 gm PO once a day PRN for constipation, Norco (opioid analgesic) 5/325 mg PO Q six hours PRN for pain and Colace (laxative) 100 mg PO one capsule QD. A joint home visit with CHHA 1 was conducted on 6/15/23 at 0900 hours, to Patient 11's home. Review of the medications was conducted with the family member and showed Norco and Colace were no longer administered to the patient Further review of the clinical record showed no documented evidence the POC included specific instructions on which medications for constipation would be given first. On 6/27/23 at 1144 hours, an interview and concurrent record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed of the finding. 2. Review of Patient 12's clinical record was initiated on 6/15/23. The clinical record showed the SOC was 4/14/23. The patient was certified for home health services during the periods from 4/14/23 to 6/12/23 and 6/13/23 to 8/11/23. The medication profile, for the certification period from 6/13/23 to 8/11/23, showed the medications included Protonix (used to treat GERD) 40 mg extended release one tablet PO QD, Megace acetate (used to treat loss of appetite) 125 mg/ml 10 ml daily, scopolamine (antiemetic) 0.00694 mg/hour 72 hour transdermal patch apply one patch Q 72 hours, and ferrous sulfate (supplement) 0.5 mg/ml five ml daily. A joint home visit with OT 1 was conducted on 6/15/23 at 1400 hours, to Patient 12's home. Review of the medications was conducted with the family member and showed the patient was no longer was taking Megace, scopolamine, and ferrous sulfate. The family member stated Protonix was being taken as needed instead of routine by the patient. On 6/27/23 at 1159 hours, an interview and concurrent record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed of the finding.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient's comprehensive assessment was completed accurately at discharge for one of 17 sampled patients (Patient 14), creating the risk of not updating the patient's accurate status. Findings: Review of Patient 14's closed clinical record was initiated on 6/14/23. The clinical record showed the SOC was 1/28/22. The patient was certified for home health services during the period from 3/29/22 to 5/27/22. The discharge assessment dated 5/19/22, showed the patient was treated for UTI in the past 14 days. Further review of the clinical record showed no documented evidence the patient was treated for UTI in the past 14 days. On 6/27/23 at 1215 hours, an interview and concurrent record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed of the findings.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the POC included specific information related to the patient's medication and fluid restriction for one of 17 sampled patients (Patient 5). This failure created the risk of not providing necessary services to this patient. Findings: Review of Patient 5's clinical record was initiated on 6/22/23. The clinical record showed the SOC was 5/2/23. The patient was certified for home health services during the period from 5/2/23 to 6/30/23. The POC, for the certification period from 5/2/23 to 6/30/23, cited SN visits 2W2 (two visits a week for two weeks) and 1W7. Documentation showed the nutritional requirements included no added salt, low fat, and low cholesterol. The physician’s order dated 5/3/23, showed SN to teach/instruct patient/PCG regarding elevating the legs to decrease edema, fluid restrictions per day, weigh patient weekly, and to report weight gain or loss of two to three pounds to the physician. * However, the physician’s order did not include the amount of fluid restrictions per day. On 6/27/23 at 1114 hours, an interview and concurrent record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed and acknowledged the findings.

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 record review and interview, the agency failed to ensure the treatments were administered only as ordered by the physician for one of 17 sampled patients (Patient 3), creating the risk of not providing appropriate, consistent, and quality care to this patient. Findings: Review of Patient 3's clinical record was initiated on 6/22/23. The clinical record showed the SOC was 1/12/23. The patient was certified for home health services during the certification periods from 1/12/23 to 3/12/23, 3/13/23 to 5/11/23, and 5/12/23 to 7/10/23. Review of Patient 3's Communication Note dated 5/2/23, showed a clarification was made for the medication order for Debrox (use to softens and loosens earwax) for BID for five days. Review of the physician's order dated 5/2/23, showed start Debrox otic solution instill five drops in each ear twice a day bilaterally for five days. SN to visit after medication is completed. SN to perform/ demonstrate the following hands-on skill: Ear Lavage. Review of the SN notes from 5/2/23 and 5/8/23, showed the SN had assessed Patient 3. However, there was no documented evidence the SN had performed an ear lavage per physician's order. On 6/27/23 at 1053 hours, an interview and concurrent clinical record review was conducted with LVN 1. LVN 1 was informed and acknowledged the findings.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure there was an effective coordination of care and services for one of 17 sampled patients (Patient 2), creating the risk of not providing necessary care and services to this patient. Findings: Review of Patient 2's clinical record was initiated on 6/22/23. The clinical record showed the SOC was 11/19/22. The patient was certified for home health services during the certification periods from 3/19/23 to 5/17/23 and 5/18/23 to 7/16/23. Review of the SOC OASIS (assessment) dated 11/19/22, showed the patient lived in a congregate situation with around the clock assistance. Review of the physician's order dated 3/22/23, showed SN to assess the patient for urinary retention and to collect urine for urinalysis with culture and sensitivity. Review of the SN note dated 3/22/23, showed the SN collected the urine sample and informed the agency the specimen was ready for pick up. Review of the Communication Note dated 3/24/23, showed the agency sent the lab report to the physician dated 3/24/23. The lab result showed a comment "no urine." Further review of the patient's clinical record failed to show the agency had followed up with the urine sample. Review of the Communication Note dated 3/29/23, showed the agency confirmed there was no urine collected for the Patient 2. Review of the Communication Note dated 4/1/23, showed the lab result was faxed to the physician. Further review of the note showed the urinalysis collection date was 3/30/23, eight days after the physician's order on 3/22/23. On 6/27/23 at 0910 hours, an interview and concurrent clinical record review was conducted with LVN 1. LVN 1 was informed and acknowledged the findings.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the agency failed to provide the written instructions on the SN visit schedule for one of 17 sampled patients (Patient 8), creating the risk of not providing the necessary information to this patient. Findings: Review of Patient 8's clinical record was initiated on 6/19/23. The clinical record showed the SOC was 3/1/23. The patient was certified for home health services during the certification periods from 3/1/23 to 4/19/23 and 4/20/23 to 6/28/23. The POC, for the certification periods from 3/1/23 to 4/19/23 and 4/20/23 to 6/28/23, cited SN visits 2W4 (two visits a week for four weeks), 1W5, and 2W5 to assess the vital signs, safety measures, pain, and healing of pressure sore. On 6/15/23 at 1420 hours, a joint home visit with LVN 2 was conducted to Patient 8's home. LVN 2 was asked for the written instructions on the SN visit schedule. Review of the written instruction on the SN visit was blank. LVN 2 stated they had forgotten to fill out the calendar and added the staff would call the patient or family member the day prior to the visit. LVN 2 was informed and acknowledged the finding. On 6/27/23 at 1138 hours, an interview and concurrent clinical record review was conducted with LVN 1. LVN 1 was informed and acknowledged the finding.

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 record review, the agency failed to maintain an infection control program related to hand hygiene for one of 17 sampled patients (Patient 10), creating the risk of the spread of infection. Findings: According to CDC, the Core Infection Prevention and Control Practices for Safe Care Delivery in All Healthcare Settings recommendations of the Healthcare Infection Control Practices Advisory Committee (HICPAC) include the following strong recommendations for hand hygiene in healthcare settings. Healthcare personnel should use an alcohol-based hand rub or wash with soap and water for the following clinical indications: - Immediately before touching a patient - Before performing an aseptic task (e.g., placing an indwelling device) or handling invasive medical devices - Before moving from work on a soiled body site to a clean body site on the same patient - After touching a patient or the patient’s immediate environment - After contact with blood, body fluids, or contaminated surfaces - Immediately after glove removal 1. Review of Patient 10's clinical record was initiated on 6/15/23. The clinical record showed the SOC was 1/7/23. The patient was certified for home health services during the period from 5/7/23 to 7/5/23. The POC, for the certification period from 5/7/23 to 7/5/23, cited SN visits 1-2 days or PRN for loss of integrity or soiling. The POC included wound treatment to the left heel as follows: cleanse the wound bed with wound cleanser, pat dry, apply Medihoney (wound dressing), then Hydrofera Blue (wound dressing) cut to shape of the wound, wrap with Kerlix roll gauze, and secure with tape, change Q one to two days or PRN for loss of integrity or when soiled or dislodged. The physician’s order dated 5/31/23, showed SN to perform on SN visits and PRN: cleanse wound with wound cleanser, pat dry, apply Medihoney, apply Hydrofera Blue cut to wound shape, hydrocolloid (wound dressing), cover with roll gauze and tape, change dressing Q one to two days or PRN for loss of integrity/soiling. A joint home visit with LVN 1 was conducted on 6/15/23 at 0900 hours, to Patient 10's home. The following was observed: RN 1 donned gloves. RN 1 removed the wound dressing from the patient’s left foot. RN 1 stated the left foot wound was healed. RN 1 doffed his gloves without performing hand hygiene. RN 1 took a photograph of the patient’s left foot using a camera phone. RN 1 placed the camera phone on his pocket. RN 1 performed hygiene after placing the camera phone on his pocket. * RN 1 failed to perform hand hygiene after the glove removal. On 6/15/23 at 1000 hours, and interview was conducted with RN 1 was informed of the findings. On 6/27/23 at 1130 hours, an interview and concurrent record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed and acknowledged the findings.

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 implement and maintain the infection control program including surveillance, identification, prevention, and control, creating the risk of the spread of infections. Findings: Review of the agency's P&P titled Infection Control Plan (undated) showed the infection control data are collected as identified in the following policies, analyzed, and trended. Information obtained will be given to management and used to improve patient/client care as well as, improve the agency’s performance in the implementation of its infection/exposure control plan. On 6/26/23 at 1000 hours, an interview was conducted with the Administrator. She stated prior to first quarter 2022, the DPCS was going back and forth for data collection with the infection control patient report and the list of patients who had antibiotics. She stated starting first quarter 2022, the data gets pulled out from the electronic medical record. She stated the patients who were on antibiotics and who had COVID-19 infection were included as infection cases. She stated the data collation were performed monthly, the Administrator/DPCS summarized the data, and the aggregated information were reported to the QAPI meeting. She stated the infection control recommendations were conducted during the QAPI meeting; the QAPI meetings were done quarterly wherein the first quarter was January to March, second quarter was April to June, third quarter was July to September, and fourth quarter was from October to December. Review of the infection control and QAPI documents was conducted on 6/26/23. The following was identified: 1. The agency failed to ensure the quarterly Infection Control Quarterly Aggregation data was consistent with the quarterly QAPI meeting minutes. In addition, the agency’s Infection Control Monthly Data was not consistent on the Infection Control Quarterly Aggregation and Analysis and QAPI meeting minutes. For example: a. Review of the fourth quarter 2021 Infection Control Quarterly Aggregation and Analysis showed there were 59 total number of infections. There was no information on how many UTIs, wound and respiratory infection for the quarter. Review of the fourth quarter 2021 QAPI Minutes and Summary showed there were 11 cases of urinary infection; six cases of wound; two upper respiratory infections; and 1 shingles, wherein the total number of infection cases was 20 cases for the quarter. However, the total number of infections documented on the fourth quarter 2021 Infection Control Quarterly Aggregation and Analysis was not consistent with what was documented on the QAPI meeting minutes. b. Review of the January, February, and March 2022 (first quarter) Infection Control Monthly Data showed there were more than 10 cases of respiratory infection wherein, there were eight cases of COVID-19, two cases of pneumonia, one case of bronchitis, one case of patient on antibiotic with COPD listed as new infection/site; and one case of "URTI" (upper respiratory tract infection) as new infection/site (s/p "Dx Covid"). The first quarter 2022 Infection Control Quarterly Aggregation and Analysis showed there were four respiratory infection cases and the first quarter 2022 QAPI meeting minutes showed there were two upper respiratory cases. However, the number of respiratory infection cases were not consistent with the agency’s first quarter 2022 Infection Control Monthly Data and the 2022 Infection Control Quarterly Aggregation and Analysis and QAPI meeting minutes. c. Review of the second quarter 2021 Infection Control Quarterly Aggregation and Analysis showed there were 50 total number of infection cases reported for January, February, and March 2021. There were 13 cases of infection for January 2021; 15 cases of infection for February 2021; and 22 cases for March 2021. Review of the second quarter 2021 QAPI Minutes and Summary showed the same information documented on the second quarter 2021 Infection Control Quarterly Aggregation and Analysis related to the total number of infections reported for January, February, and March 2021. However, the information documented for the second quarter was not accurate as the second quarter 2021 included the month of April, May, June, instead of January, February, and March (first quarter). 2.. The infection control data on each type of infection was not analyzed and specific action plan was implemented. For example: Review of the second quarter 2022 Infection Control Quarterly Aggregation and Analysis showed there were 29 total number of infections. There were 17 UTIs; 2 cases of wound infection; and 2 cases of respiratory infection. Review of the second quarter 2022 QAPI Minutes and Summary, showed nine cases of UTI; two wound cases; two upper respiratory infection and one case of eye infection. Review of the third quarter 2022 Infection Control Quarterly Aggregation and Analysis and the third Quarter 2021 QAPI meeting minutes showed 67 total infections. Documentation showed under the third quarter 2022 Infection Control Quarterly Aggregation and Analysis there were 37 cases of UTI; 15 cases of wound; and 3 cases of respiratory infection. The Infection Control Aggregation and Analysis showed no trends. The QAPI meeting minutes showed clinicians will continue to assess visit and report early sign/symptoms of infection immediately to the physician to prevent ER and hospitalizations. Documentation showed even if there was inconsistency on the number of infection cases for the second quarter 2022 Infection Control Quarterly Aggregation and Analysis and the second quarter 2022 QAPI Minutes and Summary, there was an increase in the number of UTI cases and wound infection cases from the second to the third quarter 2022. There was no documented evidence the agency identified and analyzed the increase of UTI and wound infection cases from the second to the third quarter 2022. There was no documented evidence of specific action plan implemented. d. The agency failed to ensure all reported infections for the quarter are included in the Infection Control Quarterly Aggregate and Analysis and QAPI meeting minutes. For example: Review of the first quarter 2022 (January, February, and March) Infection Control Monthly Data showed the list of the name of the patients whose SOC was from January to March 2022, medical record number, SOC date, report date, new infection site, “symptoms/lab/pathogen,“ antibiotic, “Actual (A)/Suspected (S),” and the resolved date. However, the first quarter 2022 Infection Control Monthly Data showed no documented evidence that patients whose SOC was not from January to March 2022, was included in the monthly infection control data. On 6/27/23 at 1000 hours, an interview and concurrent agency document review was conducted with the Administrator. She was informed and acknowledged the findings.

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 record review, the agency failed to ensure their COVID-19 P&P included the process by which staff may request an exemption from the COVID-19 vaccination requirements. This failure created the risk of not meeting the health and safety needs of the patient population and staff. Findings: Review of the QSO-22-07 showed the HHA’s P&Ps must include, at a minimum, a process for ensuring all staff have received, at a minimum, a process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on applicable Federal law. Review of the agency's P&P titled Mandatory Vaccination Policy (undated) showed employees may request an exception from this mandatory vaccination policy if the vaccine is medically contraindicated, a medical necessity requires a delay in vaccination, or if vaccination may conflict with a held religious belief, practice, or observance. Requests for exceptions and accommodations must be initiated by the employee and will be handled in accordance to applicable laws and regulations. However, there was no documented evidence the P&P included the process for ensuring that all documentation for the COVID-19 vaccine exemptions contain the date and signature of a licensed practitioner; all information specifying which vaccines are contraindicated for the staff members and the clinical reasons for the contraindications; and a statement by the practitioner recommending the exemption for the staff member was based on recognized clinical contraindications. In addition, the P&P failed to show a process for ensuring the tracking and documentation of vaccination status of staff whom the vaccination must be temporarily delayed. On 6/27/23 at 1326 hours, an interview and concurrent agency P&P review was conducted with the Regional DPCS. The Regional DPCS was informed and acknowledged the findings.

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 record review, the agency failed to ensure the SN provided care and services in accordance with the POC for seven of 17 sampled patients (Patients 9, 10, 11, 12, 14, 16, and 17), creating the risk of not providing appropriate, consistent, and quality care to these patients. X. Review of Patient 9's clinical record was initiated on 6/20/23. The clinical record showed the SOC was 5/13/23. The patient was certified for home health services during the period from 5/13/23 to 7/11/23. The POC, for certification period from 5/13/23 to 7/11/23, cited SN visits 1w1, 2w2 and 1w6. In addition, the POC showed SN for skilled systems assessment/ observation with emphasis on vital signs, neurological status, mental/ cognitive status, safety measures, physical mobility, pain level/ control/ effectiveness of interventions, knowledge of disease process and its associated care and treatment, medication/ diet regimen competency and compliance, response to medication signs and symptoms of complications necessitating medical attention and response to teaching, cardiovascular status, medication compliance/ effectiveness, ADL status and mobility status, psychosocial adjustment, response to medication, safety hazards, caregivers ability to care for patient. The SN notes dated 5/22, 5/25, 6/5, and 6/12/23 showed no documented evidence pain was assessed. On 6/27/23 at 1056 hours, an interview and concurrent clinical record review was conducted with LVN 1. LVN 1 was informed and acknowledged the finding. Findings: 1. Review of Patient 10's clinical record was initiated on 6/15/23. The clinical record showed the SOC was 1/7/23. The patient was certified for home health services during the period from 5/7/23 to 7/5/23. The POC, for the certification period from 5/7/23 to 7/5/23, cited SN visits 1-2 days or PRN for loss of integrity or soiling. The POC included wound treatment to left heel as follows: cleanse the wound bed with wound cleanser, pat dry, apply Medihoney (wound dressing), then Hydrofera Blue (wound dressing) cut to shape of the wound, wrap with Kerlix roll gauze, and secure with tape, change Q 1-2 days or PRN for loss of integrity or when soiled or dislodged. The POC showed SN for skilled systems assessment/observation with emphasis on vital signs, “CV/CP” status, musculoskeletal status, skin integrity, safety measures, physical mobility, pain level/control/effectiveness of interventions, knowledge of disease process and its associated care and treatment, medication/diet regimen competency and compliance, sign/symptoms of complications necessitating medical attention and response to teaching, response to wound care treatment. * The SN notes dated 5/8, 5/11, 5/13, 5/15, 5/18, 5/20, 5/22, 5/25, 5/27, 5/29, 6/1, 6/3, 6/5, 6/8, 6/10, and 6/12/23, showed no documented evidence the patient's hand grips were assessed. The SN notes dated 5/15/23, showed “treatment to left heel cleansed with wound cleanser, gently pat dry, applied medihoney, then Hydrofera blue covered with hydrocolloid dsg, wrapped with roller gauze, then secured tape a/o with site kept c/d/I and well tolerated.” The SN note dated 5/22/23, showed “Tx to left heel wound cleansed with wound cleanser, gently dried, applied medihoney, hydrofera blue, hydrocolloid, roller gauze, an then secured with tape.” * However, the POC did not include the use of hydrocolloid (wound dressing). On 6/27/23 at 1130 hours, an interview and concurrent record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed of the findings. 2. Review of Patient 11's clinical record was initiated on 6/19/23. The clinical record showed the SOC was 1/13/23. The patient was certified for home health services during the period from 5/13/23 to 7/11/23. The POC, for the certification period from 5/13/23 to 7/11/23, cited SN visits 2W4 with 1-2 PRN visits for indwelling catheter care and biliary drainage management. The POC included irrigate indwelling catheter with 50-60 cc normal saline very visit and PRN. Documentation showed to cleanse meatus with wound cleanser, gently pat dry, apply nystatin cream (antifungal) to meatal area. The POC showed SN for skilled systems assessment/observation with emphasis on vital signs, safety measures, physical mobility, and pain level/control/effectiveness of interventions The SN notes dated 5/16, 5/19, 5/23, 5/26, 6/6, 6/9, and 6/13/23, showed “glans” cleansed with wound cleanser, gently patted dry, “gent” ointment applied to “glans.” The SN notes by the LVN dated 5/31, and 6/2/23, showed “glans” cleansed with wound cleanser, gently patted dry, gentamicin ointment (topical antibiotic) applied to “glans.” * However, there was no documented evidence for the use of gentamicin ointment in the POC. The SN note dated 5/23, 6/6, 6/9, and 6/13/23 showed the patient had pain daily but not constantly. * However, there was no documented evidence on what was the patient’s pain level as per the POC. On 6/27/23 at 1144 hours, an interview and concurrent record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed of the findings. 3. Review of Patient 12's clinical record was initiated on 6/15/23. The clinical record showed the SOC was 4/14/23. The patient was certified for home health services during the periods from 4/14/23 to 6/12/23 and 6/13/23 to 8/11/23. The POC, for the certification period from 4/14/23 to 6/12/23, showed SN visits 1W8 for skilled systems assessment/observation with emphasis on vital signs, safety measures, physical mobility, pain level control/ effectiveness of interventions, knowledge of disease and its associated care and treatment, medication/diet regimen competency and compliance, sign/symptoms of complications necessitating medical attention and response to teaching, cardio-pulmonary status, medication compliance/effectiveness, nutrition/hydration, mobility status, psychosocial adjustment, response to medication, safety hazards, and caregiver’s ability to care for patient. The start of care assessment dated 4/14/23, showed no problem related to the patient’s integumentary status. The SN note dated 4/17/23, showed treatment to the patient’s Stage 2 pressure injury coccyx was performed. * However, there was no documented evidence on what the measurement of the patient’s Stage 2 pressure injury was. * The SN notes dated 4/17, 4/19, and 4/20/23, showed no documented evidence the patient’s hand grips were assessed. On 6/27/23 at 1159 hours, an interview and concurrent record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed of the findings. 4. Review of Patient 14's closed clinical record was initiated on 6/14/23. The clinical record showed the SOC was 1/28/22. The patient was certified for home health services during the period from 3/29/22 to 5/27/22. The POC, for the certification period from 4/14/23 to 6/12/23, showed SN visits 1W4 alternating with “BHRN” with 1-2 visits PRN for wound issues. The POC included SN for skilled systems assessment/observation with emphasis on vital signs, safety measures, physical mobility, pain level control/ effectiveness of interventions, knowledge of disease and its associated care and treatment, medication/diet regimen competency and compliance, sign/symptoms of complications necessitating medical attention and response to teaching, cardio-pulmonary status, medication compliance/effectiveness, nutrition/hydration, ADL status, mobility status, peripheral circulation, psychosocial adjustment, skin integrity, sign/symptoms of hypertension, sign/symptoms of hypo/hyperglycemia, sign/symptoms of infection, safety hazards, edema, sign/symptoms of dehydration and caregiver’s ability to care for patient. The SN note dated 4/29 and 5/13/22, showed no documented evidence the patient’s last bowel movement was assessed. On 6/27/23 at 1215 hours, an interview and concurrent record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed of the findings. 5. Review of Patient 16's closed clinical record was initiated on 6/21/23. The clinical record showed the SOC was 3/25/22. The patient was certified for home health services during the period from 5/24/22 to 7/22/22. The POC, for the certification period from 5/24/22 to 7/22/22, showed the following orders: - SN to perform/demonstrate the following skilled hands-on intervention. Perform wound care to sacral coccyx and right buttock wound two times a week as follows, cleanse area with dermal wound cleanser and pat dry, apply Skin Prep (protective barrier) to perimeter of wound and cover with hydrocolloid dressing (wound dressing). - SN to assess redness to left hip at each SN visit, SN may apply hydrocolloid dressing (wound dressing) for non-blanchable redness after cleansing with dermal wound cleanser. The SN note by the LVN dated 5/31, 6/3, 6/6, 6/8, 6/13, 6/17, 6/21, 6/23, and 6/26/23 showed wound care was performed on the patient’s coccyx and left hip wound. The Wound Care Worksheet dated 5/31 and 6/6/22, showed right buttock pressure injury had a measurement of 0.3 cm X 0.2 cm x 0 cm. * However, there was no documented evidence wound care was performed to the patient’s right buttock wound. On 6/27/23 at 1445 hours, an interview and concurrent record review was conducted with the Administrator and QA RN. They were informed of the findings. 6. Review of Patient 17's closed clinical record was initiated on 6/20/23. The clinical record showed the SOC was 12/21/22. The patient was certified for home health services during the period from 2/19/23 to 4/19/23. The POC, for the certification period from 2/19/23 to 4/19/23., showed SN visits 1W5. The POC included SN for skilled systems assessment/observation with emphasis on vital signs, safety measures, physical mobility, pain level control/ effectiveness of interventions, knowledge of disease and its associated care and treatment, medication/diet regimen competency and compliance, sign/symptoms of complications necessitating medical attention and response to teaching, cardiovascular status, pulmonary status, cognitive status, medication compliance/effectiveness, nutrition/hydration, GI/GU status, ADL status, mobility status, peripheral circulation, response to medication, skin integrity, sign/symptoms of infection, safety hazards, edema, PCG ability to care, response to teaching, and risks for falls. The SN note dated 2/20, 2/28, 3/3, 3/13, 3/16, and 3/22/23 showed the patient had pain daily but not constantly. * However, there was no documented evidence on what the patient’s pain level was as per the POC. The SN note dated 3/8/23, showed no documented evidence hand grips were assessed. On 6/27/23 at 1445 hours, an interview and concurrent record review was conducted with the Administrator and QA RN. They were informed of the findings.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the agency's skilled professionals prepared complete and accurate clinical notes for five of 17 sampled patients (Patients 6, 8, 12, 14, and 16), creating the increased risk of substandard healthcare outcomes to these patients. X. Review of Patient 6's clinical record was initiated on 6/19/23. The clinical record showed the SOC was 5/9/19. The patient was certified for home health services during the periods from 2/17/23 to 4/17/23 and 4/18/23 to 6/16/23. Review of the SOC OASIS dated 5/9/2019, showed Patient 6 was assessed to be hard of hearing in the left and right ears. In addition, Patient 6 was assessed to be unable to see out of the left eye. Review of the SN notes dated from 4/19 to 6/12/23 showed Patient 6's hearing and vision was assessed as "no problem". On 6/27/23 at 1108 hours, an interview and concurrent record review was conducted with LVN 1. LVN 1 was informed and acknowledged the findings. XX. Review of Patient 8's clinical record was initiated on 6/21/23. The clinical record showed the SOC was 2/28/23. The patient was certified for home health services during the periods from 2/28/23 to 4/28/23 and 4/29/23 to 6/27/23. Review of the Physical Therapy Evaluation and Plan of Care dated 3/4/23, showed the patient was assessed with left lower extremity knee extension contracture and right lower extremity, knee flexion contracture. Further review of the clinical record showed instruction was given to the caregivers for proper bed positioning, off loading techniques to prevent skin breakdown and further joint contractures. Review of the Communication Note dated 4/26/23 showed patient 8 was assessed to have stiffness in his legs that tend to cross over each other. Review of Patient 8's SN visit notes dated 3/20 to 4/26/23 and 5/1 to 6/5/23 showed under the musculoskeletal section was left blank or was assessed as "No Problem". On 6/27/23 at 1127, an interview and concurrent clinical record review was conducted with LVN 1. LVN 1 was informed and acknowledged the finding. Findings: 1. Review of Patient 12's clinical record was initiated on 6/15/23. The clinical record showed the SOC was 4/14/23. The patient was certified for home health services during the periods from 4/14/23 to 6/12/23 and 6/13/23 to 8/11/23. a. The SN note dated 4/17/23, showed a dog played with the patient and and accidentally scratched the patient's left forearm causing a skintear. Documentation showed treatment to left forearm and Stage 2 coccyx pressure injury was performed. The SN note dated 4/19/23, showed no documented evidence on what the status of the patient’s forearm skin tear and stage 2 coccyx pressure injury was. b. The physician’s order dated 5/27/23, showed OT 1W4. The OT notes dated 6/2 and 6/7/23, showed no documented evidence the patient’s pain intensity was completed. On 6/27/23 at 1159 hours, an interview and concurrent record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed of the findings. 2. Review of Patient 14's closed clinical record was initiated on 6/14/23. The clinical record showed the SOC was 1/28/22. The patient was certified for home health services during the period from 3/29/22 to 5/27/22. The SN note dated 4/7/23, showed on the narrative section of the form the patient had wound on the right hip. On another section of the narrative note showed the wound on the right hip healed. The Wound Care Worksheet dated 4/7/22, showed the right hip wound had a measurement of 0.6 cm (length) x 0.4 cm (width) x 0.1 cm (depth). * However, the wound status on the SN note and Wound Care Worksheet was not consistent. On 6/27/23 at 1215 hours, an interview and concurrent record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed of the findings. 3. Review of Patient 16's closed clinical record was initiated on 6/21/23. The clinical record showed the SOC was 3/25/22. The patient was certified for home health services during the period from 5/24/22 to 7/22/22. a. The POC, for the certification period from 5/24/22 to 7/22/22, showed the following orders: - SN to perform/demonstrate the following skilled hands-on intervention. Perform wound care to sacral coccyx and right buttock wound two times a week as follows, cleanse area with dermal wound cleanser and pat dry, apply Skin Prep (protective barrier) to perimeter of wound and cover with hydrocolloid dressing (wound dressing). - SN to assess redness to left hip at each SN visit, SN may apply hydrocolloid dressing (wound dressing) for non-blanchable redness after cleansing with dermal wound cleanser. The Communication note dated 6/4/23, showed the facility called and stated the patient had a new sore on bottom and wanted a nurse to see the patient. The SN note dated 6/6/23, showed wound care was performed on the patient’s coccyx and left hip wound. * However, there was no documented evidence on what was the status of the new sore on the bottom the facility called on 6/4/23. b. The physician’s order dated 5/20/22, showed PT 1W1, 2W1, and 1W1. The PT notes dated 5/26 and 5/28, showed no documented evidence the patient’s pain intensity was completed. On 6/27/23 at 1445 hours, an interview and concurrent record review was conducted with the Administrator and QA RN. They were informed of the findings.

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the RN provided supervision to the LVN to ensure quality of care and services were provided as per the agency's P&P for three of 17 sampled patients (Patients 10, 11, and 16), creating the risk for a substandard healthcare outcome to these patients. Findings: The agency’s P&P titled Responsibilities/Supervision of Clinical Services (undated) showed the LVN will be supervised by an RN. This supervisory visit will be documented in the visit note or in the CHHA supervisory visit form. The DPCS or designee will make onsite visit at least annually. 1. Review of Patient 10's clinical record was initiated on 6/15/23. The clinical record showed the SOC was 1/7/23. The patient was certified for home health services during the period from 5/7/23 to 7/5/23. * The SN notes by the LVN dated 5/15, 5/22, and 6/5/22, under the section of LVN supervision showed the performance of care plan elements was excellent and the rapport with the family was good. However, the documentation of the LVN supervision was completed by the LVN instead of the RN. On 6/27/23 at 1130 hours, an interview and concurrent clinical record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed of the findings. 2. Review of Patient 11's clinical record was initiated on 6/15/23. The clinical record showed the SOC was 1/13/23. The patient was certified for home health services during the period from 5/13/23 to 7/11/23 The SN notes showed the SN failed to provide care and services in accordance with the POC. Cross reference to G710, example #2. Further review of the clinical record showed the RN had conducted the LVN supervisory visit on 6/6/23, to ensure the LVN had performed care plan elements. Documentation showed the LVN performance was excellent. However, the RN failed to identify the LVN did not provide care and services in accordance with the POC. On 6/27/23 at 1144 hours, an interview and concurrent clinical record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed of the findings. 3. Review of Patient 16's closed clinical record was initiated on 6/21/23. The clinical record showed the SOC was 3/25/22. The patient was certified for home health services during the period from 5/24/22 to 7/22/22. The SN notes showed the SN failed to provide care and services in accordance with the POC. Cross reference to G710, example #5. Further review of the clinical record showed the RN had conducted the LVN supervisory visits on 6/16/23, to ensure the LVN had performed the care plan elements. Documentation showed the LVN performance was excellent. However, the RN failed to identify the LVN did not provide care and services in accordance with the POC. On 6/27/23 at 1445 hours, an interview and concurrent clinical record review was conducted with the Administrator and QA RN. They were informed of the findings.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure the written assignment for CHHA was consistently prepared by the RN for one of 17 sampled patients (Patient 1), creating the risk of not providing the necessary care and services to this patient. Findings: Review of Patient 1's clinical record was initiated on 6/22/23. The clinical record showed the SOC was 4/16/23. The patient was certified for home health services during the period from 4/16/23 to 6/14/23. The POC, for the certification period from 4/16/23 to 6/14/23, cited CHHA 1W6 to assist with bathing, personal care, assist with ambulation, assist with ADLs, ROM exercises, ADL assistance, physical care/hygiene, and other SN assigned tasks under CHHA practice. * However, the CHHA Assignment Sheet dated 4/16/23, showed the section under ADLs related to AROM/PROM was left blank, which was not consistent with the POC. On 6/27/23 at 1100 hours, an interview and concurrent clinical record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed and acknowledged the findings.

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 record review, the agency failed to ensure the CHHA provided care and services were provided in accordance with the POCs for two of 17 sampled patients (Patient 11 and 12), creating the risk of not providing necessary care and services to these patients. Findings: 1. Review of Patient 11's clinical record was initiated on 6/15/23. The clinical record showed the SOC was 1/13/23. The patient was certified for home health services during the period from 5/13/23 to 7/11/23. The CHHA Assignment Sheet dated 6/13/23, showed CHHA visits 2W4 and 1W1 to perform the following tasks: complete bed bath, assist with dressing, brush, shampoo, skin care, check pressure area, pericare, ROM Exercise per PT, AROM, catheter care, empty/change/clean urine bag, and light house keeping of the bedroom. A joint home visit with CHHA 1 was conducted on 6/15/23 at 1100 hours, to Patient 11's home. CHHA 1 provided pericare to the patient. CHHA 1 applied Thera Calazinc cream (skin protectant). However, the application of Calazinc cream was not listed in the CHHA assignment sheet. On 6/15/23 at 1100 hours, an interview with CHHA 1 was conducted. CHHA 1 stated she applied Thera Calazinc cream to the buttock area. CHHA 1 stated the patient had an order for Calmoseptine cream (skin protectant) before and the family member would ask if CHHA 1 can apply Calmoseptine cream if the patient had a breakdown. On 6/27/23 at 1144 hours, an interview and concurrent clinical record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed of the findings. 2. Review of Patient 12's clinical record was initiated on 6/15/23. The clinical record showed the SOC was 4/14/23. The patient was certified for home health services during the periods from 4/14/23 to 6/12/23 and 6/13/23 to 8/11/23. The CHHA Assignment Sheet dated 4/14/23, showed CHHA visits 1W8 to perform the following tasks: complete bed bath, assist with dressing, brush, shampoo, skin care, check pressure area, shave, groom, pericare, nail hygiene, oral care, and light housekeeping of the bedroom and bathroom. The Communication Note dated 5/17/23, showed the CHHA reported the family member “did not request it I put some Calmoseptin crean and I will see the patient again Friday.” * However, there was no documented evidence applying of Calmoseptine cream was listed in the CHHA assignment sheet. On 6/27/23 at 1159 hours, an interview and concurrent clinical record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed of the findings.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency's Administrator failed to be responsible for the day-to-day operations of the agency by not ensuring the agency’s P&P related to wound care assessment/documentation was implemented. This failure had the potential to negatively impact the agency’s operational performance. Findings: The agency’s P&P titled Job Title/Position: Administrator (undated) showed the Administrator’s job description summary included responsible for planning, coordinating, managing, and directing all activities and programs of the HHA. The essential job functions/responsibilities are to implement governing body directives and organizational policies and procedures; and ensuring the appropriate service policies are developed and implemented according to laws and regulations. The agency’s P&P titled Wound Assessment/Documentation (undated) showed patients with wound will be assessed by the clinicians on start of care, recertification, “ROC,” and reassessed every visit. Clinician will utilize a Weekly Wound Worksheet including performing measurements weekly. Review of Patient 16's closed clinical record was initiated on 6/21/23. The clinical record showed the SOC was 3/25/22. The patient was certified for home health services during the period from 5/24/22 to 7/22/22. The POC, for the certification period from 5/24/22 to 7/22/22, showed the following orders: - SN to perform/demonstrate the following skilled hands-on intervention. Perform wound care to sacral coccyx and right buttock wound two times a week as follows: cleanse area with dermal wound cleanser and pat dry, apply Skin Prep (protective barrier) to perimeter of wound and cover with hydrocolloid dressing (wound dressing). - SN to assess redness to left hip at each SN visit. SN may apply hydrocolloid dressing (wound dressing) for non-blanchable redness after cleansing with dermal wound cleanser. Review of the SN notes dated 5/31, 6/3, 6/6, 6/8, 6/13, 6/17, 6/21, 6/23, and 6/26/22 showed wound care was performed on the patient’s coccyx and left hip wound. The Wound Care Worksheet dated 5/31 and 6/6/22, showed coccyx, right buttock, and left hip pressure injuries were measured. The SN note dated 7/6/22 showed coccyx and left buttock were healed. * However, there was no documented evidence weekly wound measurements were conducted as per the agency’s P&P on Weeks 5 (6/19/22 to 6/25/22) and 6 (6/26/22 to 7/2/22). On 6/27/23 at 1445 hours, an interview and concurrent clinical record review was conducted with the Administrator and QA RN. They were informed of the findings.

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 record review, the agency failed to to send the completed discharge and transfer summaries for two of 17 sampled patients (Patients 13 and 17) to their primary care physicians. This failure created the risk for these patients to not receive continuity in care and medical treatment. #. Review of Patient 17's closed clinical record was initiated on 6/20/23. The clinical record showed the SOC was 12/21/22. The patient was certified for home health services during the period from 2/19/23 to 4/19/23. The Communication note dated 3/29/23, showed the discharge summary was faxed to the physician for review and signature. The Discharge Summary dated 3/29/23, showed the reason for discharge was the patient will be transferred to hospice. Documentation showed under the section progress towards goals and status of the problems identified during the episode was that the family agreed the care provided by hospice is beneficial . Documentation showed the patient will be admitted to hospice services on 3/30 23. * However, the completed discharge summary failed to show documented evidence of the patient outcomes in meeting the goals in the plan of care. On 6/27/23 at 1345 hours, an interview and concurrent record review was conducted with the Administrator, and QA RN. They were informed of the findings. X. Review of Patient 13's closed clinical record showed the SOC was 12/31/22. The closed clinical record showed the patient received home health services during the certification period from 12/31/22 to 2/28/23 and 3/1/23 to 4/29/23. Review of the Communication Note dated 2/9/23, showed the LVN had talked to Patient 13's family who reported Patient 13 was admitted to the hospital on 2/6-2/8/23. Review of the physician orders dated 2/15/23, showed to home health services while patient is in the hospital effective 2/6/23. May send RN for reassessment to resume home health services. Review of the fax transmittal dated 2/15/23 showed the transfer assessment, summary, and medications showed the information was sent on 2/15/23. However, the transfer summary was sent six days after the agency became aware of the unplanned transfer. On 6/27/23 at 1130 hours, an interview and concurrent clinical record review was conducted with LVN 1. LVN 1 were informed and verified the findings.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure the entries on the clinical record included the credential of the staff who completed the documents for one of 17 sampled patients (Patient 10), creating the risk of not having the complete and accurate information. Findings: Review of the agency’s P&P titled Entries Into The Clinical Record- Clinical Service Data Collection (undated) showed all clinical notes must be completed and electronically signed within seven days of the visit date. The clinical/service note will include the signature of the clinician/technician and his/her credential. Signature authorization of the clinical/service documentation will include the staff member's name and credentials (as specified on professional licenses and/or certification documents). Review of Patient 10's clinical record was initiated on 6/15/23. The clinical record showed the SOC was 1/7/23. The patient was certified for home health services during the period from 5/7/23 to 7/5/23. The SN notes dated 5/15, 5/22, 6/5, and 6/12/23, showed the notes were electronically signed by Clinician 1. Documentation showed that Clinician 1 was identified as "SN." However, the clinician's credential was not included. Review of the employee file showed Clinician 1 was a LVN. On 6/27/23 at 1130 hours, an interview and concurrent clinical record review was conducted with the Administrator, Regional DPCS, and QA RN. They were informed of the findings.