Every finding on record at Excellence Home Health Provider, Inc

The following reflects the findings of the California Department of Public Health during the concurrent Emergency Preparedness and Recertification surveys. The survey team entered the home health agency on 10/21/24 at 1030 hours. The home health agency identified the census as 140. The survey sample size was 12. GLOSSARY AND DEFINITIONS: DPCS: Director of Patient Care Services HHA: Home Health Agency

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 interview and record review, the agency failed to ensure the emergency preparedness plan included the process for collaboration with the Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. This failure created the potential risk of not providing the necessary care and services to the patients of the HHA during emergency events. Findings: Review of the agency's 2024 emergency preparedness program was conducted on 10/28/24, and showed the plan did not include a process for collaboration with the Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. On 10/29/24 at 0939 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS 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 interview and record review, the agency failed to ensure the emergency preparedness communication plan included a means of providing information about the agency's occupancy and its ability to provide assistance to the authority having the jurisdiction, the Incident Command Center, or designee. This failure created the risk of not providing the necessary care and services to the patients during the events of emergency. Findings: Review of the agency's 2024 emergency preparedness program documents was conducted on 10/28/24. However, the emergency preparedness communication plan did not include a means of providing information about the agency's occupancy and its ability to provide assistance to the authority having jurisdiction, the Incident Command Center, or designee. On 10/29/24 at 0939 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

The following reflects the findings of the California Department of Public Health during the concurrent Recertification and Emergency Preparedness Surveys. The survey team entered the home health agency on 10/21/24 at 1030 hours. The home health agency identified the census as 140. The survey sample size was 12. GLOSSARY AND DEFINITIONS: ADL: Activities of Daily Living BID: Twice a Day BLE: bilateral lower extremities BM: bowel movement BP: Blood Pressure BS: blood sugar cc: cubic centimeter(s) CEO: Chief Executive officer CHHA: Certified Home Health Aide coccyx: tail bone cm: centimeter(s) Diabetic ulcer: a serious complication caused by a combination of poor circulation, susceptibility to infection and nerve damage from high blood sugar levels DPCS: Director of Patient Care Services gm: gram(s) HHA: Home Health Agency HS: at bedtime IU: International unit IV: intravenous (a way of giving a drug or other substance through a needle or tube inserted into a vein) LVN: Licensed Vocational Nurse mcg: microgram(s) MD: Medical Doctor mg/dl: milligram per deciliter(s) meq: milliequivalent(s) mg: milligram(s) mmHg: millimeter(s) of mercury ml: milliliter(s) NS: Normal Saline OASIS: Outcome and Assessment Information Set OT: Occupational Therapy/Therapist PCG: Primary Caregiver PCP: Primary Care Physician PI: Performance Improvement PICC: peripherally inserted central catheter (used to deliver medications and other treatments directly to the large central veins near the heart) PM: Evening P&P: Policy and Procedure(s) PO: By mouth POC: Plan of Care PRN: As Needed PT: Physical Therapy/Therapist PTA: Physical Therapy Aide Q: Every QAPI: Quality Assessment and Performance Improvement QD: Daily RT: Respiratory Therapy/Therapist RN: Registered Nurse Sacrum: a shield-shaped bony structure that is located at the base of the lumbar vertebrae and that is connected to the pelvis SASH: Saline-administer medication-saline-heparin (a step-by-step process on how to flush an IV catheter) SBP: Systolic Blood Pressure (the pressure in your arteries when the heart beats and pumps blood) SC: Subcutaneous sharps disposal container: rigid puncture-resistant plastic or metal with leak-resistant sides and bottom, and a tight-fitting, puncture-resistant lid with an opening to accommodate depositing a sharp but not large enough for a hand to enter SN: Skilled Nursing/Nurse SNF: Skilled Nursing Facility SOB: Shortness of Breath SOC: Start of Care ST: Speech Therapy/Therapist Suprapubic catheter: a hollow flexible tube that is used to drain urine from the bladder Stage 1 pressure injury: observable, pressure-related alteration of intact skin with non-blanchable redness of a localized area usually over a bony prominence; may include changes in skin temperature, tissue consistency and/or sensation. 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 TB: tuberculosis (an infectious disease caused by bacteria that most often affects the lungs) TID: Three Times a Day u: unit(s) UTI: Urinary Tract Infection W: Week

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on record review and interview, the HHA failed to ensure the OASIS data was transmitted within 30 days of completing the OASIS data sets, creating the risk of not reporting and coordinating patient care assessments timely for the patients receiving care and services at the agency. Findings: Review of the OASIS validation reports dated 3/2024 to 10/2024 was initiated on 10/28/24, and showed the following: The agency's OASIS Agency Final Validation reports dated 4/24, 8/27, 9/3, 9/27, and 9/28/24, showed the OASIS data sets submitted were more than 30 days from the assessment completion date. On 10/29/24 at 0940 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

Investigate complaints made by patient CFR(s): 484.50(e)(1)(i) The HHA must— (i) Investigate complaints made by a patient, the patient's representative (if any), and the patient's caregivers and family, including, but not limited to, the following topics: (A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; (B) Mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the grievance was investigated thoroughly and the resolution was communicated in writing as per the agency's P&P. This failure had the potential for violating the patient's rights and not providing quality of care and services to this patient. Findings: The agency's P&P titled Complaint/Grievance Process revised April 2014 showed any difference of opinion, dispute, or controversy between a patient or family/caregiver or patient representative and the agency concerning any aspect of services, or the application of policies and procedures will be considered a grievance. The procedure included for the Clinical Supervisor to investigate the grievance within five (5 days) after receipt of such grievance and will make every effort to resolve the grievance to the patient satisfaction. The resolution information will be communicated in writing to the patient or his/her representative filing the complaint. Review of the agency's Grievance Log Book for the year of 2023 showed a Complaint and Resolution Form. The Complaint and Resolution Form showed a complaint dated 9/25/23, was filed by a patient caregiver. The description of the complaint was related to the agency's SN not wearing mask during the visit and did not perform the skin assessment. The resolution/action taken showed a check mark for counselling and change of discipline/assignment. However, review of the agency's documents failed to show documented evidence of the interview with the alleged nurse as part of the agency's investigation process. In addition, review of the Complaint and Resolution Form showed the description of the resolution included the section for a copy of the resolution form sent to the complainant, which was blank. The document showed a phone call was made regarding the resolution by the Administrator, which was inconsistent with the agency's P&P. On 10/29/24 at 1049 hours, an interview and concurrent document review was conducted with the DPCS. The DPCS was asked if there was a documentation of the interview with the nurse. The DPCS replied none, and they needed to interview the care coordinator and the complainant. The DPCS was also asked if they needed to file the interview that was conducted. The DPCS replied the interview documents should be filed but there was none. The DPCS was further asked if the written resolution of the complaint was sent to the complainant. The DPCS replied only a verbal phone call, none in writing and the policy was not followed. The DPCS was informed and acknowledged the findings.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the initial assessment visits were conducted within 48 hours of referral for two of 12 sampled patients (Patients 2 and 10). This failure had the potential for the risk of not providing the necessary care and services to these patients timely. Findings: 1. Review of Patient 2's closed clinical record was initiated on 10/22/24. The closed clinical record showed the SOC was 5/1/24. The patient was certified for home health services during the certification periods from 5/1/24 to 6/29/24, and 6/30/24 to 8/28/24. The patient was discharged from the agency on 8/22/24. Review of the Physician's Order dated 4/26/24, showed a referral order for home health services, home PT two times per week for balance training and lower extremities strength and to monitor the BP (blood pressure) for hypotension. However, review of the SOC OASIS dated 5/1/24, showed the SN had performed the initial assessment which was more than 48 hours from the referral date. On 10/22/24 at 1348 hours, an interview and concurrent closed medical record review was conducted with the DPCS. The DPCS was asked regarding the timeframe when to see the patient after the referral date. The DPCS replied the visit was late and it should be 48 hours from the referral date. The DPCS was informed and acknowledged the findings. 2. Review of Patient 10's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/6/23. The patient was certified for home health services during the certification period from 8/31/24 to 10/29/24. Review of the physician’s order from the SNF dated 8/30/23, showed the patient's last cover day was on 8/31/24. The physician's order showed to discharge the patient to home on 9/1/23, with home health “PT RN.” The start of care assessment showed an initial assessment visit was conducted on 9/6/23, which was more than 48 hours from the referral date. There was no documented evidence on the reason why the initial visit was not conducted within 48 hours of the referral date On 10/29/24 at 1010 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was 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 review of medications included all of the patients' current medications to identify any potential adverse effects and drug reactions for three of 12 sampled patients (Patients 10, 11, and 12). This failure posed the risk for not identifying the potential adverse effects, significant drug interactions, duplicate drug therapy, and drug reactions for these patients. 3. Review of Patient 10's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/6/23. The patient was certified for home health services during the certification period from 8/31/24 to 10/29/24. The Medication Profile for the certification period from 8/31/24 to 10/29/24, showed the patient’s medication included glargine (insulin) inject SC via sliding scale: 150-201 mg/dl= 2 units, 201-250 mg/dl= 4 units, 251-300 mg/dl= 6 units, 301-350 mg/dl= 8 units, 351-400 mg/dl= 10 units, more than 400 mg/dl call the physician; metformin (antidiabetic) 1000 mg one tablet PO BID; and Jardiance (antidiabetic) 25 mg one tablet PO QD The clinical record showed the medications listed above have been reviewed for potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and non compliance with drug therapy. According to glargine’s prescribing information, the drug interactions with glargine included antidiabetic agents which may increase the risk of hypoglycemia. * However, there was no documented evidence the agency had identified the potential drug interactions between the antidiabetic agents (glargine, metformin, and Jardiance). On 10/29/24 at 1010 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 1.Review of Patient 11's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/18/24. The patient was certified for home health services during the certification period from 9/18/24 to 11/16/24. The Medication Profile for the certification period from 9/18/24 to 11/16/24, showed the patient's medications included Vygart Hytrulo (treatment for myasthenia gravis) 1,008 mg-11,200 units/5.6 ml subcutaneous solution one time a week treatment cycle for 4 weeks, 28 days off then 4 weeks treatment cycle, hydralazine (antihypertensive) 25 mg one tablet by PO BID, clonidine (antihypertensive) 0.1 mg tablet PO QD PRN for SBP more than 160 mmHg every 3 PM and Lasix (diuretics) 20 mg one tablet PO QD PRN for edema. A joint home visit with OT was conducted on 10/22/24 at 1000 hours, to Patient 11's home. Review of the patient's medications with the OT and the PCG showed the patient was on Alive women multivitamin (supplement) one capsule QD, Pyridostigmine bromide (to improve muscle strength) 60 mg two tablets BID PRN for diplopia, dysphagia and SOB, Vitamin D (supplement) 25 meq QD, MK-7 Multivitamin K2 (supplement) 90 meq QD, Florastor probiotic (supplement) one capsule QD, Vitamin B-12 (supplement) one capsule QD and Lutein zeaxanthin (support eye health) one capsule QD. These medications were not listed on the medication profile. However, these were not listed in the medication profile. In addition, patients was taking hydralazine (antihypertensive) 25 mg one tablet by PO TID instead of BID as written on the medication profile. On 10/29/24 at 1146 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 2. Review of Patient 12's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 10/1/24. The patient was certified for home health services during the certification period from 10/1/24 to 11/29/24. The Medication Profile for the certification period from 10/1/24 to 11/29/24 showed the patients medication included metoprolol (antihypertensive) one tablet PO BID, levothyroxine (thyroid agents) 50 mcq one tablet PO QD, empagliflozin (antidiabetic) 12.5 mg -metformin 1,000 mg one table PO BID, benazepril (antihypertensive) 20 mg one tablet PO QD, Eliquis (anticoagulant) 2.5 mg two tablets PO BID, triamterene (antihypertensive) 37.5 mg- hydrochlorothiazide 25 mg PO one tablet PO QD, rosuvastatin (antilipidemic) 20 mg PO QD and nateglinide (antidiabetic) 60 mg two tablets PO QD. A joint home visit was conducted on 10/22/24 at 1300 hours to Patient 12's home. Review of the patient medication with the PT and the PCG showed the patient was taking Januvia (antidiabetic) 100 mg one tablet PO QD, Vitamin D5 (supplement)1000 IU one capsule QHS and Tylenol (analgesic) 500 mg one tablet PRN. These medications were not included on the medication profile. In addition, patient was taking nateglinide (antidiabetic) 120 mg tablet one tablet PO before breakfast, one tablet PO before lunch and 1.5 tablet before dinner instead of 60 mg PO BID as written on the medication profile. Further, patients was taking rosuvastatin (antilipidemic) 20 mg PO QHS instead of QD as written on the medication profile. On 10/29/24 at 1058 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessments were updated within the last five days of every 60 days for four of 12 sampled patients (Patients 3, 5, 7, and 10). This failure had the potential for not addressing the care needs for these patients. 3. Review of Patient 10's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/6/23. The patient was certified for home health services during the certification period from 8/31/24 to 10/29/24. The recertification assessment dated 8/26/24, showed the patient had a Stage 1 coccyx pressure injury. Documentation showed the coccyx was cleansed with normal sterile saline, patted dry, and applied Calmoseptine (moisture barrier) cream to affected area, and left open to air. * However, there was no documented evidence of the size of the patient's Stage 1 coccyx pressure injury.. On 10/29/24 at 1010 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 4. Review of Patient 3's closed clinical record was initiated on 10/23/24. The clinical record showed the SOC was 7/26/23. The patient was certified for home health services during the certification periods from 9/26/23 to 11/24/23 and 11/25/23 to 1/23/24. The recertification assessment dated 11/24/23, showed the patient’s skin was intact. The POC, for the certification period 11/25/23 to 1/23/24, showed SN to perform treatment to rash on left inner thigh. The POC showed to cleanse with NS, pat dry, apply triple antibiotic to affected area leave open to air, daily until end of certification. The POC included PCG to do treatment during non-SN visit days. * However, there was no documented evidence of the patient’s skin rash in the recertification assessment dated 11/24/23. There was no assessment on what the size of the skin rash was. On 10/29/24 at 1043 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. Review of the agency's P&P titled Reassessment/Recertification revised 4/14, showed the procedure includes for each new episode of care, a comprehensive assessment will be completed no earlier than (5) five days before and no later than (1) one day before the calendar day on which the new episode of care begin. 1.Review of Patient 5's clinical record was initiated on 10/25/24. The closed clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification period from 8/19/24 to 10/7/24 and 10/18/24 to 12/16/24. The Recertification Follow Up Assessment dated 10/16/24, showed the RN had started the recertification comprehensive assessment. The section A- Administrative Information was completed. However, the RN failed to complete the comprehensive assessment as the status shown "in progress". On 10/29/24 at 1258 hours, an interview and concurrent clinical record review was conducted with the DCPCS. The DPCS was asked as to the completion of the recertification assessment. The DPCS replied, within last 5 days of recertification period, it was late. The DPCS was informed and acknowledged the finding. 2. Review of Patient 7's clinical record was initiated on 10/24/24. The clinical record showed the SOC was 8/5/24. The patient was certified for home health services during the certification period from 8/5/24 to 10/3/24 and 10/4/24 to 12/2/24. The Recertification Follow Up Assessment dated 10/3/24, showed the assessment was "in progress". The assessment was blank. The assessment also showed the attestation for the staff signature was blank. On 10/24/24 at 1508 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was asked as to the timeline for the completion of the recertification assessment as it shows "in progress". The DPCS replied, it was late and was completed today. The DPCS provided the updated/completed assessment. Review of the Recertification Follow Up Assessment dated 10/3/24, showed the status was locked and the locked date was 10/7/24. The attestation for the staff electronic signature was dated 10/24/24 at 1401 hours. However, the assessment was not completed timely as shown by the RN attestation date. On 10/29/24 at 1118 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the update comprehensive assessment was completed within 48 hours of the patient's return to home from the acute care hospital for two of 12 sampled patients (Patients 5 and 8). This failure created the risk of not providing the necessary care and services timely to meet the care needs for these patients. Findings: Review of the agency's P&P titled Initial and Comprehensive Assessment revised 4/14 showed the assessment will be patient specific and comprehensive to include the patient's need for home health care, rehabilitative care, social services and discharge planning. The assessment will be completed within 48 hours of the patients return home from a 24 -hour acute care hospital admission. 1. Review of Patient 5's clinical record was initiated on 10/25/24. The closed clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification periods from 8/19/24 to 10/7/19 and 10/18/24 to 12/16/24. Review of the Transfer to Inpatient Facility assessment showed the patient transfer date was 9/30/24. Review of the Physician's Order dated 10/4/24 at 1430 hours, showed an order for resumption of care. Review of the Resumption of Care assessment (after Inpatient Stay) for the certification period 8/19/24 to 10/7/19, showed the date of assessment was 10/4/24. However, the assessment was blank. On 10/25/24 at 1416 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was asked regarding the date of assessment completed. The DPCS replied it was assessed on 10/4/24, but was not completed. On10/29/24 at 1319 hours, a follow-up interview and concurrent clinical record review was conducted with the DPCS. The DPCS was asked as to the timeframe for the completion of the resumption of care assessment. The DPCS replied within 48 hours from the return from the acute care hospital, and it was late. The DPCS was informed and acknowledged the findings. 2. Review of Patient 8's clinical record was initiated on 10/23/24. The clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification periods from 8/19/24 to 10/17/24, and 10/18/24 to 12/16/24. Review of the Resumption of Care (after Inpatient stay) dated 10/16/24, showed the RN had performed the comprehensive assessment. The comprehensive assessment showed the patient was discharged from the acute care hospital on 10/12/24. However, the RN performed the comprehensive assessment four days after the patient was discharged from the acute care hospital instead of 48 hours. On 10/29/24 at 1530 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the discharge assessments were completed for one of 12 sampled patients (Patient 1). This failure had the potential for not addressing the care needs for this patient. Findings: Review of Patient 1's closed clinical record was initiated on 10/22/24, and showed the SOC was 3/25/24. The patient was certified for home health services during the certification periods from 3/25/24 to 5/23/24. The patient was discharged from the agency on 5/17/24. Review of the Physician's Order dated 5/17/24, showed an order for discharge from the agency per the patient's request. Review of the Discharge OASIS dated 5/17/24, showed a section for the condition at the time of discharge. The condition included the patient with Stage 2 pressure injury involving sacral and bilateral buttocks are healing. Review of the Discharge OASIS for the section of Wound/Lesion showed documented evidenced of the Stage 2 pressure injury to the sacral region. However, the wound assessment was incomplete. In addition, on the section for Bladder and Bowel, the RN failed to document the date of the patient's last bowel movement. On 10/29/24 at 1203 hours, an interview and concurrent closed clinical record review was conducted with the DPCS. The DPCS was asked if the discharge assessment related to the patient's Stage 2 pressure injury to the sacral area was complete and the last bowel movement was documented. The DPCS replied no. The DPCS was informed and acknowledged 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 interview and record review, the agency failed to ensure the POC was completed timely and included the required elements in the POC for five of 12 sampled patients (Patients 2, 5, 6, 8, and 10). This failure had the potential for not addressing the care needs for these patients. 1.Review of Patient 2's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 5/1/24. The patient was certified for home health services during the certification periods from 5/1/24 to 6/29/24 and 6/30/24 to 8/28/24. The patient was discharge from the agency on 8/22/24. The POC, for the certification period from 6/30/24 to 8/28/24, cited SN visits 1W9 (one time per week for nine weeks) for all body system assessments. The POC also showed the patient principal diagnosis was orthostatic hypotension. However, the POC failed to include specific instructions on how to check for the patients vital signs to check for signs of orthostatic hypotension. On 10/29/24 at 1231 hours an interview and concurrent closed medical record review was conducted with the DPCS. The DPCS was asked how to check for the orthostatic hypotension. The DPCS replied, need to check the blood pressure while lying, sitting and standing position. The DPCS was asked if it needed to be included in the POC. The DPCS replied, it should. The DPCS was informed and acknowledged the finding. 2. Review of Patient 5's clinical record was initiated on 10/25/24. The closed clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification period from 8/19/24 to 10/7/24 and 10/18/24 to 12/16/24. The POC, for the certification period from 10/18/24 to 12/16/24, showed the patients principal diagnosis, the orders for discipline and treatments and other notes. However, the POC was incomplete. On 10/25/24 at 1445 hours, an hours an interview and concurrent closed medical record review was conducted with the DPCS. The DPCS was asked if the POC was complete. The DPCS replied, no because the recertification assessment was not completed yet. The DPCS was informed and acknowledged the findings. 3. Review of Patient 6's clinical record was initiated on 10/24/24. The closed clinical record showed the SOC was 6/27/22. The patient was certified for home health services during the certification period from 8/15/24 to 10/13/24 and 10/14/24 to 12/12/24. The POC, for the certification period from 8/15/24 to 10/13/24, cited SN visits 1W9 for assessments of all body system. The POC also showed the patients principal diagnosis was chronic lymphocytic leukemia. The patient was assessed to have multiple pertinent diagnoses including loss of appetite. The medications include Dronabinol (appetite stimulant) 2.5 mg one capsule PO before lunch and two capsules before dinner. Review of the Recertification OASIS dated 8/12/24, showed the SN documented the patients reported weight was 90 lbs. and height of 64 inches. However, review of the POC failed to include specific instructions related to the frequency of weight check to address the patients principal and pertinent diagnosis. On 10/25/24 at 1402 hours, an hours an interview and concurrent closed medical record review was conducted with the DPCS. The DPCS was asked if the POC was specific to address the patients diagnosis of chronic lymphocytic leukemia and loss of appetite. The DPCS replied, no, the POC should include weight check. The DPCS was informed and acknowledged the findings. 4. Review of Patient 8's clinical record was initiated on 10/23/24. The closed clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification period from 8/19/24 to 10/17/24 and 10/18/24 to 12/16/24. The POC, for the certification period from 10/18/24 to 12/16/24, cited SN visits 1W9 for assessments of all body system. The POC includes the patients multiple pertinent diagnosis. The diagnosis includes chronic respiratory failure with hypoxia and dependence on supplemental oxygen. The POC also includes SN to assess the patients vital signs. However, the vital signs assessment did not include the checking of the oxygen saturation to address the patients chronic respiratory failure and dependence on supplemental oxygen. On 10/29/24 at 1510 hours, an hours an interview and concurrent closed medical record review was conducted with the DPCS. The DPCS was asked if the oxygen saturation needed to be included in the POC. The DPCS replied, yes, it should. The DPCS was informed and acknowledged the findings. 5. Review of Patient 10's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/6/23. The patient was certified for home health services during the certification period from 8/31/24 to 10/29/24. The POC, for the certification period from 8/31/24 to 10/29/24, showed the medications included glargine (insulin) inject SC via sliding scale: 150-201 mg/dl= 2 units, 201-250 mg/dl=4 units, 251-300 mg/dl=6 units, 301-350 mg/dl=8 units, 351-400 mg/dl=10 units, and more than 400 mg/dl call the physician. * However, there was no documented evidence on what the frequency of the insulin administration was as per sliding scale. On 10/29/24 at 1010 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. Findings: 1. Review of Patient 2's closed clinical record was initiated on 10/22/24. The clinical record showed the SOC was 5/1/24. The patient was certified for home health services during the certification periods from 5/1/24 to 6/29/24, and 6/30/24 to 8/28/24. The patient was discharged from the agency on 8/22/24. The POC, for the certification period from 6/30/24 to 8/28/24, cited SN visits 1W9 (one time per week for nine weeks) for all body system assessments. The POC also showed the patient's principal diagnosis was orthostatic hypotension. However, the POC failed to include specific instructions on how to check for the patients' vital signs to check for signs of orthostatic hypotension. On 10/29/24 at 1231 hours, an interview and concurrent closed clinical record review was conducted with the DPCS. The DPCS was asked how to check for the orthostatic hypotension. The DPCS stated the staff needed to check the blood pressure while lying, sitting, and standing position. The DPCS was asked if it needed to be included in the POC. The DPCS replied it should. The DPCS was informed and acknowledged the findings. 2. Review of Patient 5's closed clinical record was initiated on 10/25/24. The closed clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification periods from 8/19/24 to 10/7/24, and 10/18/24 to 12/16/24. The POC, for the certification period from 10/18/24 to 12/16/24, showed the patient's principal diagnosis, the orders for discipline and treatments and other notes. However, the POC was incomplete. On 10/25/24 at 1445 hours, an interview and concurrent closed clinical record review was conducted with the DPCS. The DPCS was asked if the POC was completed. The DPCS replied no because the recertification assessment was not completed yet. The DPCS was informed and acknowledged the findings. 3. Review of Patient 6's closed clinical record was initiated on 10/24/24. The closed clinical record showed the SOC was 6/27/22. The patient was certified for home health services during the certification periods from 8/15/24 to 10/13/24, and 10/14/24 to 12/12/24. The POC, for the certification period from 8/15/24 to 10/13/24, cited SN visits 1W9 for assessments of all the body system. The POC also showed the patient's principal diagnosis was chronic lymphocytic leukemia. The patient was assessed to have multiple pertinent diagnoses including loss of appetite. The medications included Dronabinol (appetite stimulant) 2.5 mg one capsule PO before lunch and two capsules before dinner. Review of the Recertification OASIS dated 8/12/24, showed the SN documented the patient's reported weight was 90 lbs and height of 64 inches. However, review of the POC failed to include specific instructions related to the frequency of weight check to address the patient's principal and pertinent diagnosis. On 10/25/24 at 1402 hours, an interview and concurrent closed clinical record review was conducted with the DPCS. The DPCS was asked if the POC was specific to address the patient's diagnosis of chronic lymphocytic leukemia and loss of appetite. The DPCS stated no, the POC should include weight check. The DPCS was informed and acknowledged the findings. 4. Review of Patient 8's clinical record was initiated on 10/23/24. The closed clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification periods from 8/19/24 to 10/17/24 and 10/18/24 to 12/16/24. The POC, for the certification period from 10/18/24 to 12/16/24, cited SN visits 1W9 for assessments of all body system. The POC included the patient's multiple pertinent diagnosis. The diagnosis includes chronic respiratory failure with hypoxia and dependence on supplemental oxygen. The POC also includes SN to assess the patient's vital signs. However, the vital signs assessment did not include the checking of the oxygen saturation to address the patient's chronic respiratory failure and dependence on supplemental oxygen. On 10/29/24 at 1510 hours, an interview and concurrent closed clinical record review was conducted with the DPCS. The DPCS was asked if the oxygen saturation monitoring should be included in the POC. The DPCS replied, yes, it should. The DPCS was informed and acknowledged the findings. 5. Review of Patient 10's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/6/23. The patient was certified for home health services during the certification period from 8/31/24 to 10/29/24. The POC, for the certification period from 8/31/24 to 10/29/24, showed the medications included glargine (insulin) inject SC via sliding scale as follows: BS 150-201 mg/dl= 2 units, 201-250 mg/dl=4 units, 251-300 mg/dl=6 units, 301-350 mg/dl=8 units, 351-400 mg/dl=10 units, and more than 400 mg/dl, to call the physician. * However, there was no documented evidence of the frequency for the insulin administration as per the sliding scale. On 10/29/24 at 1010 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the SN provided wound treatment in accordance with the physician's order for one of 12 sampled patients (Patient 7). This failure had the potential for not providing appropriate care to this patient. Findings: Review of Patient 7's clinical record was initiated on 10/24/24. The clinical record showed the SOC was 8/5/24. The patient was certified for home health services during the certification periods from 8/5/24 to 10/3/24, and 10/4/24 to 12/2/24. The POC, for the certification period from 8/5/24 to 10/3/24, cited SN visits 2W8 for assessment of all body system. The POC also included SN to perform wound assessment and treatment to the patient's diabetic ulcer on the left heel as follows: cleanse with NS and pat dry, apply betadine (disinfectant) around the wound and Santyl ointment (debridement agent) inside the wound, cover with an abdominal pad, wrap with Kerlix (roll gauze) and Coban (self-adhesive bandage) 3x/week and as needed if soiled or dislodged. a. Review of the SN visit note dated 10/14/24, under the narrative note section showed the SN had performed assessment and treatment to the patient's left heel diabetic ulcer. The treatment showed the wound was covered with calcium alginate (a fibrous, absorbent material that comes in various forms, such as pads, ribbons, and flat dressings) and a waterproof bordered foam dressing was applied. Review of the SN note dated 10/16/24, under the narrative note section showed the SN had performed treatment to the patient's left heel diabetic ulcer. The treatment showed the wound was covered with the calcium alginate and border foam dressing. However, review of the clinical record failed to show documented evidenced of the physician's order for the calcium alginate. On 10/29/24 at 1118 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. b. Review of the SN note dated 9/11/24, showed the SN had performed wound assessment and treatment to the patient's left heel diabetic ulcer. Further, review of the SN note showed the SN had performed wound dressing to the patients left big toe as follows: cleansed with NS, patted dry, and applied triple antibiotic ointment. However, review of the clinical record failed to show documented evidenced of the physician's order for the use of triple antibiotic ointment. On 10/2/24 at 1131 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

Communication with all physicians CFR(s): 484.60(d)(1) Standard: Coordination of Care. The HHA must: (1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the coordination of care for four of 12 sampled patients (Patients 4, 5, 7, and 11). This failure had the potential for not providing necessary care and services to these patients. Findings: 1. Review of the agency's P&P titled Missed Visits (undated) showed the missed visits will be communicated to the clinical supervisor and or the patient's physician. A missed visit will be rescheduled the same week if possible. The procedure includes if a visit is missed for any reason, the clinician should attempt to reschedule it for the same week so that the physician ordered frequency is maintained and would not be considered a missed visit. Document in the patient's clinical record the physician notification including date, time, physician name, method of notification and the staff reporting the information. Review of Patient 11's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/18/24. The patient was certified for home health services during the certification period from 9/18/24 to 11/16/24. The Physician's Order dated 9/20/24, cited OT visits 1W4 and 2W1. The OT notes showed the OT visited the patient on 9/20/24, during the week of 9/18/24 to 9/21/24, and on 9/25/24 during week 9/22/24 to 9/28/24. Further review of the OT notes showed during the week of 9/29/24 to 10/5/24, there was a missed OT visit on 10/4/24, and the MD was notified. However, there was no documented evidence the OT had attempted to schedule a visit on the next day 10/5/24, to ensure the OT services were provided as ordered. The Physician's Order dated 10/7/24, showed a change in OT visit frequency to 1W6. However, there was no documented evidence the OT had attempted to schedule a visit on the next day from 10/8/24 to 10/12/24, to ensure the OT services were provided as ordered. In addition, during the week of 10/13/24 to 10/19/24, there was no documented evidenced of the OT visit. Moreover, review of the clinical record failed to show documented evidenced the physician was notified of the OT missed visits. On 10/29/24 at 1202 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 2. Review of Patient 5's clinical record was initiated on 10/25/24. The clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification periods from 8/19/24 to 10/17/24, and 10/18/24 to 12/16/24. The POC, for the certification period from 8/19/24 to 10/17/24, cited SN visits 3W1, 2W1, and 1W7 for all the body system assessments. Review of the clinical record showed a missed visit on 10/14/24, during Week 9. However, review of the clinical record failed to show documented evidenced the physician was notified of the missed visit. On 10/29/24 at 1139 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 3. Review of Patient 4's clinical record was initiated on 10/25/24. The closed clinical record showed the SOC was 11/11/22. The patient was certified for home health services during the certification period from 9/1/24 to 10/30/24. The POC, for the certification periods from 9/1/24 to 10/30/24, cited SN visits 1W1 for all the body system assessments. The POC included SN for suprapubic catheter dressing daily. If patient was unable to go to the urologist office, the SN may insert/change suprapubic catheter (14 Fr/30 cc) every 30 days or as needed for leaking and accidental pulling out while observing clean technique and proper disposal of solid materials. Review of the SN note dated 9/21/24, showed the SN visited the patient to perform a scheduled suprapubic catheter change. The SN inserted suprapubic 14 Fr. catheter using sterile technique. However, review of the clinical record failed to show documented evidenced of the communication/coordination note as to the reason why the patient was unable to go to the urologist office prior to the SN reinsertion of the suprapubic urinary catheter. On 10/29/24 at 13114 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was asked as to how they knew if the patient was unable to go the urologist office. The DPCS reviewed the clinical record and stated no coordination or communication notes documented. The DPCS was informed and acknowledged the findings. 4. Review of Patient 7's clinical record was initiated on 10/24/24. The clinical record showed the SOC was 8/5/24. The patient was certified for home health services during the certification periods from 8/5/24 to 10/3/24, and 10/4/24 to 12/2/24. The POC, for the certification period from 8/5/24 to 10/3/24, cited SN visits 3W8 for assessment of all the body system. Review of the SN notes showed the following: -For Week 1 (from 8/5/24 to 8/10/24), the SN visited the patient on 8/5 and 8/7/24, instead of three visits as ordered. -For Week 3 (from 8/18/24 to 8/24/24), the SN visited the patient on 8/19 and 8/21/24, instead of three visits as ordered. In addition, review of the clinical record failed to show documented evidenced of the physician notification for the missed visits. Review of the SN narrative note dated 9/11/24, showed the SN had performed wound dressing to the patient's left big toe as follows: cleansed with NS, patted dry, and applied triple antibiotic ointment. However, review of the clinical record failed to show documented evidenced the physicians was notified of the patient's wound on the left big toe. On 10/29/24 at 1131 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS 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 outlining the SN visit schedule for three of 12 sampled patients (Patients 10, 11, and 12). This failure had the potential for not providing the necessary information to these patients. 3. Review of Patient 10's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/6/23. The patient was certified for home health services during the certification period from 8/31/24 to 10/29/24. The POC, for the certification period from 8/31/24 to 10/29/24, showed SN visits 2W8. On 10/23/24 at 0900 hours, a joint home visit was conducted with LVN 1 and the Office Clerk to Patient 10’s home. Review of the patient’s admission packet provided by the HHA showed no documented evidence of the written instructions outlining the SN visit schedules. On 10/29/24 at 1010 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 1.Review of Patient 11's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/18/24. The patient was certified for home health services during the certification period from 9/18/24 to 11/16/24. The POC, for the certification period from 9/18/24 to 11/16/24, cited SN for evaluation and ST visits 1W1, 2W2 and OT visits 1W4, 2W1. A joint home visit with OT was conducted on 10/22/24 at 1000 hours, to Patient 11's home. The patient/PCG was asked for the written instructions outlining the SN, OT and ST visit schedule. The PCG replied they called and scheduled with her daughter. The OT was also asked, how does the patient know your visit schedule. The OT replied, " I called back and forth for the visit schedule". Review of the patient's home folder provided by the HHA showed the visit calendar was blank and no documented evidence of the written instructions outlining the SN, OT and ST visit schedule. The OT was asked if she utilized the visit calendar, OT stated " I didn't know they have that". On 10/29/24 at 1146 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the finding. 2. Review of Patient 12's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 10/1/24. The patient was certified for home health services during the certification period from 10/1/24 to 11/29/24. A joint home visit with OT was conducted on 10/22/24 at 1300 hours, to Patient 11's home. The PCG was asked for the written instructions outlining the SN and PT visit schedule. The PCG replied, "my mother has her own calendar ". Review of the patient's home folder provided by the HHA showed the visit calendar was blank and no documented evidence of the written instructions outlining the SN, and PT visit schedule. The PT was asked if she uses the visit calendar, PT replied no. On 10/29/24 at 1058 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the finding.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to measure, analyze, and track quality indicators to assess the processes of care as part of the QAPI program. This failure created the risk of not identifying areas for performance improvement to improve care and services provided to the patients. Findings: The agency’s P&P titled Improving Organizational Performance dated 04/2014 showed the following: Senior management will carry the responsibility: to guide the organization's efforts in improving organizational performance in governance, management, clinical and support activities; to define expectations of the performance improvement activities; to define the frequency and detail of data collection; and to generate the plan and processes the organization will utilize to assess, improve and maintain quality of care and service. -Senior management will set expectations for performance improvement and manage processes to improve organization performance. -Senior management will adopt a scientific, problem-solving approach to performance improvement. The scientific, problem-solving approach will include, minimally: Planning for performance improvement with integration of information from other relevant activities- Risk management, Utilization management, Quality control, infection control surveillance, and patient safety program Setting priorities for improvement and adjusting priorities in response to unusual or urgent events. Systemic assessment of performance through comparison of organizational performance: internally over time, to the performance of similar process in other organizations, and to external sources of information. Implementing improvement on the basis of assessment and comparison data. Maintaining achieved improvements Identifying and establishing activities to measure patient outcomes -Senior management will allocate resources for assessing improving and communicating the organization's performance by: Assigning organization personnel to participate in performance improvement activities Providing adequate time for organization personnel to participate in performance improvement activities Creating and maintaining information systems and data management processes to support collecting, managing and analyzing data to improve performance Utilizing appropriate statistical techniques to analyze and display data. Statistical facts to include: run charts that display summary comparison data, Scatter diagrams, Control charts that display variations and trends over time, histograms, Pareto charts, cause-and-effect or fishbone diagrams, Process flowcharts, Provide organization personnel training in effective approaches and methods of assessment and improvement, Assessing the adequacy of human, information, physical, and financial resources allocated to support performance improvement and patient safety -Senior Management will analyze and assess the effectiveness of their contributions to improving organization performance, including review of leadership performance against pre-established, objective process criteria. The senior management, also, measure and assess the performance improvement and safety improvement activities. -Senior management will ensure that an integrated patient safety program is implemented throughout the organization -Senior management will ensure that the infection control program is an integral part of the organization’s safety and performance improvement program On 10/28/24 at 1249 hours, an interview was conducted with the DPCS. She stated the QAPI meetings were done quarterly. She stated the QAPI topic/problem in the quarterly QAPI documents was their PI project. The QAPI members discussed infections, patient satisfaction, “STAR” rating, and incident reports. She stated the QAPI members discussed recommendations and action plan for the problems identified. She stated the QAPI members who attended the QAPI meeting included the Administrator, DPCS, RN Supervisor, and LVN Care Coordinator. 1. Review of the 2022 QAPI documents showed the following information: For the second quarter and third quarter 2022, the QAPI documents included the Quality of Patient Care Star Rating Provider Preview report and Preview of the HHA Quality Measures Score to be Posted on Care Compare with the same date range. For the fourth quarter 2022, the QAPI documents included Potentially Avoidable Event Report. * There was no documented evidence of QAPI meeting minutes and attendance of the QAPI members for the 2nd, 3rd, and 4th quarters of 2022. In addition, there was no documented evidence the agency measured, analyzed, and tracked adverse patient events and infection control data for the 2nd and 3rd quarters of 2022; and there was no documented evidence the agency analyzed and tracked adverse patient events and infection control data for the 4th quarters of 2022. 2. The QAPI documents for the 1st, 3rd, and 4th quarters of 2023 and 1st, 2nd, and 3rd quarters of 2024, showed one different focus topic/problem for each quarter. Documentation showed the quarterly meetings by the QAPI members. * However, there was no documented evidence the agency analyzed and tracked quality indicators, including adverse patient events, infection control data, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. On 10/29/24 at 0959 hours, an interview and concurrent agency document review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to utilize the quality indicator data in the design of its program. This failure created the risk of not improving care and services provided to the patients. Findings: Review of the 2023 and first, second, and third quarters of 2024 GB meeting minutes showed the meetings were conducted. However, there was no documented evidence of the frequency and detail of the data collection for the QAPI program. Review of the first, third, and fourth quarters of 2023 QAPI documents; and the first, second, and third quarter 2024 QAPI documents showed one focus topic/problem for each quarter. The focus topic was changed every quarter. However, there was no documented evidence of data collection on the selected focus topic/problem for each quarter. There was no documented evidence of the tool used to collect the data. On 10/29 at 0954 hours, an interview and concurrent agency document review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

Program activities CFR(s): 484.65(c) (1) The HHA's performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure the PI activities focused on high risk, high volume, and problem-prone areas. This failure had the potential to adversely affect the quality of care provided to the patients. Findings: On 10/28/24 at 1249 hours, an interview was conducted with the DPCS. She stated the QAPI meetings were done quarterly. She stated the QAPI topic/problem in the quarterly QAPI documents were the HHA's PI project. The QAPI documents for 2023 and the first, second, and third quarters of 2024, showed one different focus topic/problem for each quarter. * However, there was no documented evidence to show if the selected focus topic/problem for each quarter was the high risk, high volume, or problem area of the HHA. There was no documented evidence of data available for review. On 10/29 at 0954 hours, an interview and concurrent agency document review was conducted with the DPCS. The DPCS was informed and acknowledged the finding.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on interview and record review, the hospice failed to document the measurable progress achieved on the 2023 and 2024 PI project. This created the risk of not identifying the opportunity for improvement for care and services provided the patients. Findings: Review of the QAPI documents for the 1st, 3rd, and 4th quarters of 2023; and the 1st and 2nd quarter of 2024, showed a focus topic/problem for each quarter. However, there was no documented evidence of the result and progress of the performance improvement project conducted for the above quarters. There was no documented evidence the recommendations were reevaluated to ensure the effectiveness of implemented plan to improve patient care and performance. On 10/29/24 at 0954 hours, an interview and concurrent agency document review was conducted with the DPCS. The DPCS 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 the disposal of syringes for one of 12 sampled patients (Patient 9), creating the risk of the spread of infections. Findings: The agency’s P&P titled Standard Precautions dated 4/2014 showed organization personnel will adhere to the following precautions and will instruct patients and family/caregivers in infection control precautions, as appropriate to the patient’s care needs. The P&P showed for syringe/sharps disposal: in the home setting, a sharps disposal container will be available for use by the clinician or patient and family/caregiver. When ¾ full, the disposal container will be sealed and transported to the dirty supply area located in the office. A new container should be provided to the patient for any future use. The agency’s P&P titled Contaminated Waste Disposal dated 4/2014 showed the procedure for sharps included: needles, syringes, and razor blades should be placed in a puncture proof container and labeled as contaminated waste when ¾ full. Puncture proof containers should be bagged, secured, and returned to the office for disposal. Review of Patient 9's clinical record was initiated on 10/21/24. The clinical record showed the SOC was 10/17/24. The patient was certified for home health services during the certification period from 10/17/24 to 12/15/24. The POC, for the certification period from 10/17/24 to 12/15/24, showed RN to perform as follows: -Infuse ceftriaxone (antibiotic) 2 gm/20 ml sterile water for injection over 10 minutes via PICC line every 24 hours via slow IV push -Infuse ampicillin (antibiotic) 8 gm/480 ml normal saline (salt solution) over 24 hours continuously via PICC line every 24 hours via Elastomeric pump (a medical device used for infusing medication). -Flush IV catheter with 5-10 ml 0.9% sodium chloride before and after each dose, followed by 3-5 ml of 100 u/ml of heparin (anticoagulant) using the SASH method (Saline-Administer medication-Saline-Heparin). A joint home visit with RN 1 was conducted on 10/22/24 at 1630 hours, to Patient 9’s home. The following was observed: RN 1 flushed the patient’s right arm single lumen PICC line with a prefilled saline syringe followed by a prefilled heparin syringe, administered ceftriaxone via IV push then, flushed the patient’s right arm single lumen PICC line with a prefilled saline syringe followed by a prefilled heparin syringe, and administered ampicillin by connecting the Elastomeric pump . RN 1 disposed the used syringes in a red bag. After the visit RN 1 closed and took the red bag with him outside of the patient’s home. * However, RN 1 disposed the used prefilled saline and heparin syringes in a red bag, instead of a sharp disposal container. On 10/22/24 at 1730 hours, an interview was conducted with RN 1. He stated he flushed Patient 9’s right arm PICC line with 10 cc saline followed by 5 cc heparin, then administered ceftriaxone IVP then, flushed the PICC line again with 10 cc saline followed by 5 cc heparin and administered ampicillin by connecting the Elastomeric pump. When asked how he would dispose the used saline and heparin syringes. He stated the red bag will be “double bagged" and he have a container to place the red bag in his vehicle. He stated he will either dispose the red bag in a biohazard container at the HHA’s location or at his other place of employment. On 10/23/24 at 1000 hours, an interview was conducted with the DPCS. She stated the used syringes for IV flushes are disposed in a sharp container. The DPCS stated the container should be puncture resistant. The DPCS stated if a patient was receiving IV therapy, the pharmacy would send a sharp container. The DPCS stated the nurses were to dispose the used syringes in the sharp container. The DPCS stated the sharp container would be brought back to the HHA’s office and placed in a biohazard container for disposal. On 10/29/24 at 0955 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. She stated RN 1 came and disposed the red bag at the HHA’s office last week.

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 which included surveillance, identification, prevention, control, and investigation of infections. This failure had the potential for spread of infections. Findings: Review of the agency's P&P titled Infection Prevention and Control: Evaluating and Maintaining Records of Infections Among Patients dated 04/2014, showed the following: -All patients with a new, actual, or suspected infection will have a patient infection report completed within 24 hours of discovery. If trends are discovered, target surveillance or problem-oriented surveillance may be initiated for specific high-risk patient populations if high volume, problem-prone areas are identified. -The Infection Identification Patient Report Form is completed when any of the following occur: A. A new, actual, or suspected infection is clinically observed by home health personnel B. A culture is ordered and performed, and the results are positive C. A new antibiotic is ordered D. A patient is admitted to a hospital due to an actual or suspected infection E. An unanticipated death due to an actual or suspected infection F. A major permanent loss of function associated with an actual or suspected infection G. A reportable, communicable infection is identified H. Patient has temperatures greater than 101 degrees F I. Patient has conjunctivitis -The Case Manager or nurse caring for the patient in his/her absence should complete the Infection Identification Patient Report within 24 hours of discovering the infection. -Each section of the report should be completed in its entirety. -After completion, the original form will be sent to the Performance Improvement Coordinator, and a copy will be submitted to the appropriate personnel for follow-up. -Clinical Managers are responsible for tracking verified infections via new antibiotic orders or positive lab results. -The Performance Improvement Coordinator or designee summarizes, trends, and analyzes the reports. The break down and summary may include but will not be limited to: a. Number of infection types b. Sources of infection c. Diagnoses d. age/sex of patients e. Family/caregiver f. Pathogens, if identified g. Follow-up taken -The Performance Improvement Coordinator or designee, in conjunction with the Clinical Manager, will investigate possible causal factors and recommend appropriate action to contain the transmission of the infection. Actions may include implementing target or problem surveillance to aid in identifying causal factors and appropriate recommendations. -A report on infections will be given at each Performance Improvement Committee meeting. A summary will be forwarded to the appropriate Governing Body committee. -Information from the summary, analysis, and discussion will be used as part of the organization's risk analysis and annual evaluation of the organization's infection prevention and control activities. 1. Review of the infection control documents from the 2nd, 3rd, and 4th quarters of 2022 and the 1st, 2nd, and 3rd quarters of 2024, showed the HHA had collected the infection control cases for the patients. Further review of the infection control program showed no documented evidence the agency had summarized, tracked, trended, analyzed the data, investigated for possible causes of infections, and implemented specific actions to minimize infections. 2. Review of the infection control documents from January to December 2023 showed the HHA documented the individual infection control report and collected the infection control cases for the patients monthly. a. The 2023 Infection Control Summary Report Chart showed a graph of the annual report with the types of infection and the percentages. However, the quarterly infection control documents failed to track and trend all types of infection. For example: The first quarter 2023 infection control documents showed no documented evidence the infection cases were tracked and trended. The second quarter 2023 Infection Summary Report Chart showed a graph which included 23 urinary infections. The other types of infections such as respiratory and wound cases were not included. The third quarter 2023 Infection Summary Report Chart showed a graph which included five cases of wound infection. The other types of infections such as respiratory and urinary cases were not included. The fourth quarter 2023 Infection Summary Report Chart showed there were 12 cases of urinary infection, seven cases of wound infection, and 4 cases of respiratory infection. The other types of infection such as ear infection was not included. b. There was no documented evidence the agency had summarized, analyzed the data, thoroughly investigated for possible causes of infections, and implemented specific actions to minimize infections. For example: The 2023 2nd quarter QAPI document dated 6/21/23, showed there was a problem on the increase incidence of UTI. Documentation showed the root cause was the visiting nurses lack of staff information regarding how to instruct patient/s caregivers about preventing UTI. * However, there was no documented evidence on how the HHA identified the increase in the incidence of UTI as there was no summary and analysis on what the number of cases of UTI from the previous month was. There was no data collection on how the HHA concluded that the root cause was the visiting nurses lack of staff information on how to instruct the patients/caregivers about preventing UTI. The 2023 third quarter Infection Summary Report Chart showed five cases of wound infection. * However, there was no documented evidence the agency had summarized other types of infection, analyzed the data, investigated for possible causes of infections, and implemented specific actions to minimize infections. c. Some of the individual Infection Control Report was not completed entirely. For example: The Infection Control Report of Patient A dated 1/30/23, showed the site of suspect/actual infection was urinary. Documentation showed the patient was on Cipro (antibiotic) 500 mg one tablet PO for 10 days. The section for the sign and symptoms observed related to the presence of infection showed the date first observed was 1/30/23. However, there was no information as what the signs/symptoms were. On 10/28/24 at 1248 hours, an interview was conducted with the DPCS. She stated if the patient was placed on an antibiotic, the LVN care coordinator will write the physician's order for antibiotic and document on the individual infection control report. The RN supervisor will collect and print the infection cases every month. She stated the RN supervisor will summarize and analyze the data. The data will be discussed during the QAPI quarterly meeting for recommendations and action plan. On 10/29/24 at 0954 hours, an interview and concurrent agency document review was conducted with the DPCS. She 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 observation, interview, and record review, the agency failed to ensure the patients received care and services as per the written POCs for seven of 12 sampled patients (Patients 1, 4, 5, 7, 8, 9, and 10). This failure had the potential for not providing appropriate, consistent, and quality care to these patients. 1.Review of Patient 1's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 3/25/24. The patient was certified for home health services during the certification periods from 3/25/24 to 5/23/24. The patient was discharge from the agency on 5/17/24. The POC, for the certification period from 3/25/24 to 5/23/24, cited SN visits 2W2 (two times a week for two weeks),1W7. The POC showed SN to assess wound status, size, depth, drainage, color, presence or absence of necrotic tissue, surrounding skin, signs and symptoms of infections and complications in wound healing. Review of the SN visit notes dated 4/3, 4/9, 4/18 and 5/9/24, showed the SN had performed body system assessment. The assessment includes Wound Type. The wound type was documented as decubitus stage 2. However, review of the Wound Care Worksheet dated 4/3, 4/9, 4/18 and 5/9/24 failed to show documented evidenced of the wound assessment was performed as ordered by the physician. On 10/29/24 at 1203 hours, an interview and concurrent closed clinical record review was conducted with the DPCS. The DPCS was asked if the SN performed the wound assessment as ordered. The DPCS checked the SN visit notes and replied, no. The DPCS was informed and acknowledged the findings. 2. Review of Patient 5's clinical record was initiated on 10/25/24. The closed clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification period from 8/19/24 to 10/7/24 and 10/18/24 to 12/16/24. The POC, for the certification period from 8/19/24 to 10/7/19 cited SN visits 3W1, 2W1, 1W7 for the assessment of all body system. The patient principal diagnosis was encounter for surgical aftercare following surgery on digestive system. The POC also includes SN to perform wound treatment to multiple surgical sites on the abdomen: Cleanse with NS and pat dry. Apply Betadine solution to affected areas, cover with dry dressing and secure with tape 2x a week and as needed of soiled until end of certification. SN to assess wound status, size, depth, drainage, color, presence or absence of necrotic tissue, surrounding skin, signs and symptoms of infections and complications in wound healing. Review of the SN notes showed the SN visited the patient on 9/13,Week 4 (from 9/8/24 to 9/14/24), on 9/18/24, Week 5 (from 9/15/24 to 9/21/24 and on 9/27/24, Week 6 (from 9/22/24 to 9/28/24). However, review of the medical record failed to show documented evidenced the RN had performed wound treatment and assessment as ordered by the physician. On 10/29/24 at 1338 hours, an interview and concurrent clinical was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 3. Review of Patient 4's clinical record was initiated on 10/25/24. The closed clinical record showed the SOC was 11/11/22. The patient was certified for home health services during the certification period from 9/1/24 to 10/30/24. The POC, for the certification period from 9/1/24 to 10/30/24 cited SN visits 2W8, 1W1 for assessment of all body systems. The POC also include suprapubic catheter, change dressing daily. SN may flush catheter with 30 to 60 cc sterile normal prn 1to 2x per week. Review of the SN notes dated 10/7 and 10/12/24, showed the SN had performed catheter flush. However, the SN flushed the catheter with NS at 100 ml instead of 30 to 60 cc as ordered by the physician. On 10/29/24 at 1338 hours, an interview and concurrent clinical was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 4. Review of Patient 7's clinical record was initiated on 10/24/24. The clinical record showed the SOC was 8/5/24. The patient was certified for home health services during the certification period from 8/5/24 to 10/3/24 and 10/4/24 to 12/2/24. The POC for the certification periods from 8/5/24 to 10/3/24, cited SN visits 3W8 for assessment of all body system. The POC also showed SN to assess wound status, size, depth, drainage, color, presence or absence of necrotic tissue, surrounding skin, signs and symptoms of infection and complications in wound healing. Review of the SN notes dated 8/29/24, showed the SN had performed wound treatment to the patients second degree burn to the left heel. However, the SN failed to performed wound assessment to the patients second degree burn to the left heel. In addition, review of the SN narrative note dated 9/11/24 on the section of narrative notes, showed the SN had performed wound dressing to the patients left big toe: cleanse with NS, pat dry and triple antibiotic was applied. However, review of the clinical record failed to show documented evidenced of the wound assessment for the patients left big toe wound. On 10/29/24 at 1131 hours, an interview and concurrent clinical was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 5. Review of Patient 8's clinical record was initiated on 10/23/24. The closed clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification period from 8/19/24 to 10/17/24 and 10/18/24 to 12/16/24. Review of the Resumption of Care Orders dated 9/20/24, cited SN visits daily until 10/1/24 for continue assessment of patients overall condition. SN to perform treatment and dressing to the patients right abdominal area drain site, buttocks extending to the perineal area blanchable redness, and left second toe open blister. Review of the SN notes dated 9/22, 9/23, 9/24, 9/25, 9/26, 9/27 and 9/28/24 showed the SN had performed wound treatment as ordered. However, the SN failed to performed wound assessment as ordered by the physician. Review of the SN visit notes dated 4/3, 4/9, 4/18 and 5/9/24, showed the SN had performed body system assessment. The assessment includes Wound Type. The wound type was documented as decubitus stage 2. On 10/29/24 at 1530 hours, an interview and concurrent clinical was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 6. Review of Patient 9's clinical record was initiated on 10/21/24. The clinical record showed the SOC was 10/17/24. The patient was certified for home health services during the certification period from 10/17/24 to 12/15/24. The POC, for the certification period from 10/17/24 to 12/15/24, showed RN to perform as follows: -SN to drain right mid trunk nephrostomy tube bag daily. -Infuse ceftriaxone (antibiotic) 2 gm/20 ml sterile water for injection over 10 minutes via PICC line every 24 hours via slow IV push -Infuse ampicillin (antibiotic) 8 gm/480 ml normal saline (salt solution) over 24 hours continuously via PICC line every 24 hours via Elastomeric pump -Flush IV catheter with 5-10 ml 0.9% sodium chloride before and after each dose, followed by 3-5 ml of 100 u/ml of heparin (anticoagulant) using the SASH method (Saline-Administer medication-Saline-Heparin). A joint home visit with RN 1 was conducted on 10/22/24 at 1630 hours, to Patient 9’s home. The following was observed: a. RN 1 flushed the patient’s right arm single lumen PICC line with a prefilled saline syringe followed by a prefilled heparin syringe, administered the ceftriaxone via IV push, then flushed the patient’s right arm single lumen PICC line with a prefilled saline syringe followed by a prefilled heparin syringe, and administered ampicillin by connecting the Elastomeric pump (a medical device used for infusing medication). * However, RN 1 flushed the single lumen PICC line with a prefilled heparin syringe prior to the administration of the ceftriaxone via IV push and ampicillin via the Elastomeric pump, instead of administration of a prefilled saline syringe only as per the POC. On 10/22/24 at 1730 hours, an interview was conducted with RN 1. He stated he flushed Patient 9’s right arm PICC line with 10 cc saline followed by 5 cc heparin, then administered ceftriaxone IVP, then flushed the PICC line again with 10 cc saline followed by 5 cc heparin, then administered ampicillin by connecting the Elastomeric pump. b. RN 1 assessed patient’s nephrostomy tube bag. The bag had light yellow colored liquid. * However, RN 1 failed to drain the nephrostomy tube bag as per the POC. On 10/29/24 at 0955 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. The DPCS stated the procedure to flush a PICC line when administering IV medication would be saline, administer medication, saline, followed by heparin if the IV medication was administered intermittently. 7. Review of Patient 10's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/6/23. The patient was certified for home health services during the certification period from 8/31/24 to 10/29/24. The POC, for the certification period from 8/31/24 to 10/29/24, showed SN visits 2W8. The POC included the following: -Skilled assessment of all body systems. -SN to weigh the patient once weekly and notify the physician of any weigh loss or gain of five pounds and more. -Non pressure chronic ulcer of the right distolateral extremity: cleanse with wound cleanser, apply Santyl ointment (wound dressing) and mupirocin (topical antibiotic0 mixture “1:1” to wound bed and cover with bordered gauze; and change dressing three times s a week. Once by the wound specialist and twice by the SN. -Redness to coccyx: cleanse with normal saline and pat dry, apply Calmoseptine cream to affected area and leave open to air once daily and PRN. PCG to perform on SN non visit days. -SN to assess wound status, size, depth, drainage, color, presence or absence of necrotic tissue, surrounding skin, signs/symptoms of healing, signs/symptoms of infection, complications in wound healing, patient and caregiver’s knowledge and compliance with wound care procedure, and management of disease process a. * The SN note dated 10/4/24, showed the patient’s temperature, blood pressure, pulse, and respiration were not completed. b. There was no documented evidence the SN weighed the patient once weekly as per the POC on Week 2 (9/1/24 to 9/7/24), Week 4 (9/15/24 to 9/21/24), Week 5 (9/22/24 to 9/28/24), Week 6 (9/29/24 to 10/5/24), and Week 7 (10/6/24 to 10/12/24). c. The recertification assessment dated 8/26/24, showed the patient had Stage 1 coccyx pressure injury. *The SN note during Week 2 (9/1/24 to 9/7/24), showed no documented evidence the patient’s Stage 1 coccyx pressure injury was assessed for size as per the POC. The SN note dated 9/9/24, showed the patient had redness to coccyx and treatment was performed The SN note dated 9/11/24, showed the SN to assess buttock area during visits and to apply Calmoseptine as needed. *However, there was no documented evidence on what the status of the patient’s Stage 1 coccyx pressure during Week 3 (9/8/24 to 9/14/24) was. d. The recertification assessment dated 8/26/24, showed the patient had non-pressure chronic ulcer to the right distolateral extremity. The physician’s order dated 10/11/24, showed the non-pressure chronic ulcer to the right distolateral extremity was resolved. There was no documented evidence on what the wound size of was on the non-pressure chronic ulcer to the right distolateral extremity Week 4 (9/15/24 to 9/21/24), Week 5 (9/22/24 to 9/28/24), and Week 6 (9/29/24 to 10/5/24). On 10/29/24 at 1010 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. Findings: 1.Review of Patient 1's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 3/25/24. The patient was certified for home health services during the certification period from 3/25/24 to 5/23/24. The patient was discharge from the agency on 5/17/24. The POC, for the certification period from 3/25/24 to 5/23/24, cited SN visits 2W2 (two times a week for two weeks),1W7. The POC showed SN to assess wound status, size, depth, drainage, color, presence or absence of necrotic tissue, surrounding skin, signs and symptoms of infections and complications in wound healing. Review of the SN visit notes dated 4/3, 4/9, 4/18 and 5/9/24, showed the SN had performed body system assessment. The assessment included wound type which was documented as decubitus (pressure injury) stage 2. However, review of the Wound Care Worksheet dated 4/3, 4/9, 4/18 and 5/9/24 failed to show documented evidence wound assessments were performed as ordered by the physician. On 10/29/24 at 1203 hours, an interview and concurrent closed clinical record review was conducted with the DPCS. The DPCS was asked if the SN performed the wound assessment as ordered. The DPCS reviewed the SN visit notes and replied no. The DPCS was informed and acknowledged the findings. 2. Review of Patient 5's clinical record was initiated on 10/25/24. The closed clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification periods from 8/19/24 to 10/7/24 and 10/18/24 to 12/16/24. The POC, for the certification period from 8/19/24 to 10/7/19, cited SN visits 3W1, 2W1, 1W7 for the assessment of all body system. The patient principal diagnosis was encounter for surgical aftercare following surgery on digestive system. The POC also included SN to perform wound treatment to multiple surgical sites on the abdomen: cleanse with NS and pat dry. Apply Betadine (topical antiseptic) solution to affected areas, cover with dry dressing and secure with tape two times a week and as needed if soiled until end of certification. SN to assess wound status, size, depth, drainage, color, presence or absence of necrotic tissue, surrounding skin, signs and symptoms of infections and complications in wound healing. Review of the SN notes showed the SN visited the patient on 9/13, 9/18, and 9/27/24. However, review of the clinical record failed to show documented evidenced the RN had performed wound treatment and assessment as ordered by the physician. On 10/29/24 at 1338 hours, an interview and concurrent clinical was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 3. Review of Patient 4's clinical record was initiated on 10/25/24. The closed clinical record showed the SOC was 11/11/22. The patient was certified for home health services during the certification period from 9/1/24 to 10/30/24. The POC, for the certification period from 9/1/24 to 10/30/24, cited SN visits 2W8, 1W1 for assessment of all body systems. The POC also included suprapubic catheter, change dressing daily. SN may flush catheter with 30 to 60 cc sterile normal PRN one to two times per week. Review of the SN notes dated 10/7 and 10/12/24, showed the SN had flushed the catheter. However, the SN flushed the catheter with NS at 100 ml instead of 30 to 60 cc as ordered by the physician. On 10/29/24 at 1338 hours, an interview and concurrent clinical was conducted with the DPCS. The DPCS was informed and acknowledged the finding. 4. Review of Patient 7's clinical record was initiated on 10/24/24. The clinical record showed the SOC was 8/5/24. The patient was certified for home health services during the certification periods from 8/5/24 to 10/3/24 and 10/4/24 to 12/2/24. The POC, for the certification periods from 8/5/24 to 10/3/24, cited SN visits 3W8 for assessment of all body system. The POC also showed SN to assess wound status, size, depth, drainage, color, presence or absence of necrotic tissue, surrounding skin, signs and symptoms of infection and complications in wound healing. Review of the SN notes dated 8/29/24, showed the SN had performed wound treatment to the patient's second degree burn to the left heel. However, the SN failed to performed wound assessment to the patients second degree burn to the left heel. In addition, review of the SN narrative note dated 9/11/24 on the section of narrative notes, showed the SN had performed wound dressing to the patients left big toe: cleanse with NS, pat dry and triple antibiotic was applied. However, review of the clinical record failed to show documented evidenced of the wound assessment for the patients left big toe wound. On 10/29/24 at 1131 hours, an interview and concurrent clinical was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 5. Review of Patient 8's clinical record was initiated on 10/23/24. The closed clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification period from 8/19/24 to 10/17/24 and 10/18/24 to 12/16/24. Review of the Resumption of Care Orders dated 9/20/24, cited SN visits daily until 10/1/24 for continue assessment of patients overall condition. SN to perform treatment and dressing to the patients right abdominal area drain site, buttocks extending to the perineal area blanchable redness, and left second toe open blister. Review of the SN notes dated 9/22, 9/23, 9/24, 9/25, 9/26, 9/27 and 9/28/24 showed the SN had performed wound treatment as ordered. However, the SN failed to performed wound assessment as ordered by the physician. Review of the SN visit notes dated 4/3, 4/9, 4/18 and 5/9/24, showed the SN had performed body system assessment. The assessment includes Wound Type. The wound type was documented as decubitus stage 2. On 10/29/24 at 1530 hours, an interview and concurrent clinical was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 6. Review of Patient 9's clinical record was initiated on 10/21/24. The clinical record showed the SOC was 10/17/24. The patient was certified for home health services during the certification period from 10/17/24 to 12/15/24. The POC, for the certification period from 10/17/24 to 12/15/24, showed RN to perform as follows: -SN to drain right mid trunk nephrostomy tube bag daily. -Infuse ceftriaxone (antibiotic) 2 gm/20 ml sterile water for injection over 10 minutes via PICC line every 24 hours via slow IV push -Infuse ampicillin (antibiotic) 8 gm/480 ml normal saline (salt solution) over 24 hours continuously via PICC line every 24 hours via Elastomeric pump -Flush IV catheter with 5-10 ml 0.9% sodium chloride before and after each dose, followed by 3-5 ml of 100 u/ml of heparin (anticoagulant) using the SASH method (Saline-Administer medication-Saline-Heparin). A joint home visit with RN 1 was conducted on 10/22/24 at 1630 hours, to Patient 9’s home. The following was observed: a. RN 1 flushed the patient’s right arm single lumen PICC line with a prefilled saline syringe followed by a prefilled heparin syringe, administered the ceftriaxone via IV push, then flushed the patient’s right arm single lumen PICC line with a prefilled saline syringe followed by a prefilled heparin syringe, and administered ampicillin by connecting the Elastomeric pump (a medical device used for infusing medication). * However, RN 1 flushed the single lumen PICC line with a prefilled heparin syringe prior to the administration of the ceftriaxone via IV push and ampicillin via the Elastomeric pump, instead of administration of a prefilled saline syringe only as per the POC. On 10/22/24 at 1730 hours, an interview was conducted with RN 1. He stated he flushed Patient 9’s right arm PICC line with 10 cc saline followed by 5 cc heparin, then administered ceftriaxone IVP, then flushed the PICC line again with 10 cc saline followed by 5 cc heparin, then administered ampicillin by connecting the Elastomeric pump. b. RN 1 assessed patient’s nephrostomy tube bag. The bag had light yellow colored liquid. * However, RN 1 failed to drain the nephrostomy tube bag as per the POC. On 10/29/24 at 0955 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. The DPCS stated the procedure to flush a PICC line when administering IV medication would be saline, administer medication, saline, followed by heparin if the IV medication was administered intermittently. 7. Review of Patient 10's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/6/23. The patient was certified for home health services during the certification period from 8/31/24 to 10/29/24. The POC, for the certification period from 8/31/24 to 10/29/24, showed SN visits 2W8. The POC included the following: -Skilled assessment of all body systems. -SN to weigh the patient once weekly and notify the physician of any weigh loss or gain of five pounds and more. -Non pressure chronic ulcer of the right distolateral extremity: cleanse with wound cleanser, apply Santyl ointment (wound dressing) and mupirocin (topical antibiotic0 mixture “1:1” to wound bed and cover with bordered gauze; and change dressing three times s a week. Once by the wound specialist and twice by the SN. -Redness to coccyx: cleanse with normal saline and pat dry, apply Calmoseptine cream to affected area and leave open to air once daily and PRN. PCG to perform on SN non visit days. -SN to assess wound status, size, depth, drainage, color, presence or absence of necrotic tissue, surrounding skin, signs/symptoms of healing, signs/symptoms of infection, complications in wound healing, patient and caregiver’s knowledge and compliance with wound care procedure, and management of disease process a. * The SN note dated 10/4/24, showed the patient’s temperature, blood pressure, pulse, and respiration were not completed. b. There was no documented evidence the SN weighed the patient once weekly as per the POC on Week 2 (9/1/24 to 9/7/24), Week 4 (9/15/24 to 9/21/24), Week 5 (9/22/24 to 9/28/24), Week 6 (9/29/24 to 10/5/24), and Week 7 (10/6/24 to 10/12/24). c. The recertification assessment dated 8/26/24, showed the patient had Stage 1 coccyx pressure injury. *The SN note during Week 2 (9/1/24 to 9/7/24), showed no documented evidence the patient’s Stage 1 coccyx pressure injury was assessed for size as per the POC. The SN note dated 9/9/24, showed the patient had redness to coccyx and treatment was performed The SN note dated 9/11/24, showed the SN to assess buttock area during visits and to apply Calmoseptine as needed. *However, there was no documented evidence on what the status of the patient’s Stage 1 coccyx pressure during Week 3 (9/8/24 to 9/14/24) was. d. The recertification assessment dated 8/26/24, showed the patient had non-pressure chronic ulcer to the right distolateral extremity. The physician’s order dated 10/11/24, showed the non-pressure chronic ulcer to the right distolateral extremity was resolved. There was no documented evidence on what the wound size of was on the non-pressure chronic ulcer to the right distolateral extremity Week 4 (9/15/24 to 9/21/24), Week 5 (9/22/24 to 9/28/24), and Week 6 (9/29/24 to 10/5/24). On 10/29/24 at 1010 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was informed and acknowledged 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 clinical records were complete and accurate for eight of twelve sampled patients (Patients 1, 2, 3, 4, 7, 8, 10, and 12), creating the risk of substandard care provided to these patients as their clinical information were not accurate and complete. 7. Review of Patient 10's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/6/23. The patient was certified for home health services during the certification period from 8/31/24 to 10/29/24. a. The recertification assessment dated 8/26/24, showed the patient’s reported weight was 148 pounds. The SN note dated 9/9/24, showed the patient’s weigh was 186 pounds. On 10/29/24 at 1010 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS stated the patient’s weight in the SN note was inaccurate and a typographical error. The DPCS was informed and acknowledged the findings. 8. Review of Patient 3's closed clinical record was initiated on 10/23/24. The clinical record showed the SOC was 7/26/23. The patient was certified for home health services during the certification periods from 9/26/23 to 11/24/23 and 11/25/23 to 1/23/24. The POC during the certification periods from 9/26/23 to 11/24/23 and 11/25/23 to 1/23/24, showed the patient’s nutritional requirement was plant-based diet. The patient’s other pertinent diagnosis included "PREDIABETES 8/25/2023." * However, the SN notes during the certification periods from 9/26/23 to 11/24/23 and 11/25/23 to 1/23/24, showed the patient’s diet information was blank. The SN note dated 1/10/24, showed under endocrine assessment the patient had no diabetes mellitus diagnosis. The narrative section of the note showed SN instructed that a controlled carbohydrate diet is prescribed for people with diabetes. * However, there was inconsistency with the SN’s endocrine assessment, instruction, and the POC regarding diabetes. On 10/29/24 at 1043 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. Review of the agency's P&P titled Entries into the Clinical Record revised 4/14, showed the policy for documentation in the clinical record will be timely, detailed, accurate, and reflect the care and services provided. The procedures includes the entries into the clinical record will be clear, concise, and specific statements of fact. Entries into the clinical record will be made on the day care is provided to the patient. All documentation will be turned into the office at the end of the workday and clinical notes dictated or written will be incorporated into the patients health record at least every seven working days. 1.Review of Patient 1's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 3/25/24. The patient was certified for home health services during the certification periods from 3/25/24 to 5/23/24. The patient was discharge from the agency on 5/17/24. The POC, for the certification period from 3/25/24 to 5/23/24, cited SN visits 2W2 (two times a week for two weeks),1W7. The POC showed SN to assess wound status, size, depth, drainage, color, presence or absence of necrotic tissue, surrounding skin, signs and symptoms of infections and complications in wound healing. Review of the SN visit notes dated 3/28, 4/3, 4/9 and 4/18/24, showed the SN had performed body system assessment. The assessment includes Integumentary System. The integumentary system assessment showed a check marked on intact. However, on the section of Wound Type showed patient was assessed to have a decubitus Stage 2 which was inaccurate. On 10/29/24 at 1203 hours, an interview and concurrent closed clinical record review was conducted with the DPCS. The DPCS was asked if the skin assessment was accurate. The DPCS checked the SN visit notes and replied, it was inaccurate. The DPCS was informed and acknowledged the findings. 2. Review of Patient 2's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 5/1/24. The patient was certified for home health services during the certification periods from 5/1/24 to 6/29/24 and 6/30/24 to 8/28/24. The patient was discharge from the agency on 8/22/24. Review of the Recertification Assessment dated 6/26/24, under the section of musculoskeletal showed patient was assessed to have generalized pain and weakness of BLE (bilateral lower extremities). The assessment also showed poor conditioning and decrease ROM (range of motion) on the bilateral lower extremities. The POC, for the certification period from 6/30/24 to 8/28/24, cited SN visits 1W9 (one time per week for nine weeks) for all body system assessments. Review of the SN notes dated 7/2, 7/9,7/14, 7/23, 7/30, 8/7, 8/14, and 8/22 showed the SN had performed body system assessment. The assessment includes Motor/Musculoskeletal system. However, the SN placed a check marked on the section of no problem which was inconsistent with the recertification assessment. In addition, review of the Discharge OASIS under the section of Summary for certification period showed, patient was seen by SN and PT for two certification periods and provided disease, pain, medication management, HEP (home exercises program), gait, transfer and balance training. The patient will be starting outpatient rehabilitation. However, review of the closed medical record showed patient was not being seen by PT on the current certification period which was inaccurate. On 10/29/24 at 1231 hours, an interview and concurrent closed clinical record review was conducted with the DPCS. The DPCS was asked if there was an order for PT on this certification period. The DPCS checked the notes and replied, no, PT was on the first certification period only. The DPCS was also asked if the SN assessment for the motor/musculoskeletal assessment is accurate. The DPCS replied, it was inaccurate. The DPCS was informed and acknowledged the findings. 3. Review of Patient 12's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 10/1/24. The patient was certified for home health services during the certification period from 10/1/24 to 11/29/24. The POC for the certification periods from 10/1/24 to 11/29/24 cited SN visits 1W1, 2W7 and 1W1 for all body system assessments. Review of the SN visit notes dated 10/8, 10/11 and 10/15/24 showed the SN had a visit. However, the body system assessment were left blank. On 10/29/24 at 1108 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was asked if there was an SN missed visits. The DPCS replied, there was a visit but there were no notes available. The DPCS was informed and acknowledged the findings. 4. Review of Patient 4's clinical record was initiated on 10/25/24. The closed clinical record showed the SOC was 11/11/22. The patient was certified for home health services during the certification period from 9/1/24 to 10/30/24. The POC for the certification periods from 9/1/24 to 10/30/24 cited SN visits 1W1 for all body system assessments. Review of the SN notes dated 9/5, 9/10, 9/17, 9/24, 9/30 and 10/5/24 showed the SN had performed wound assessment and treatment to the patients stage 2 pressure injury to the right buttocks. The assessment includes a section if a wound photograph was taken. The SN marked yes on the section if the photo was taken. However, review of the medical record failed to show documented evidenced of a wound photographs were taken for the patients stage 2 pressure injury to the right buttocks which was inconsistent. In addition, review of the SN notes dated 10/5, 10/7, 10/12/24, showed the SN had assessed the patient integumentary system. The assessment showed a check mark on intact. However, on the section of the narrative notes showed the patient had a suprapubic catheter. The SN instructed the patient/PCG to the signs and symptoms of wound infection which was inconsistent with the integumentary assessment. On 10/29/24 at 1338 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 5. Review of Patient 7's clinical record was initiated on 10/24/24. The clinical record showed the SOC was 8/5/24. The patient was certified for home health services during the certification period from 8/5/24 to 10/3/24 and 10/4/24 to 12/2/24. The POC for the certification periods from 8/5/24 to 10/3/24, cited SN visits 2W8 for assessment of all body system. The POC also includes SN to performed wound assessment and treatment to the patients diabetic ulcer to the left heel: cleanse with NS and pat dry. Apply betadine around the wound and Santyl ointment inside the wound, cover with abdominal pad, wrap with kerlix and Coban 3x/week and as needed if soiled or dislodged. Review of the Wound Care Worksheet dated 10/14/24, showed the SN had performed wound assessment and treatment to the patients diabetic ulcer to the left heel. The treatment showed cleanse with NS and pat dry. Apply betadine around the wound and Santyl ointment inside the wound, cover with dry dressing. However, review of the SN visit notes dated 10/14/24 under the section of the narrative note showed, the SN had performed assessment and treatment to the patients diabetic ulcer to the left heel. The treatment showed the wound was covered with calcium alginate and a waterproof bordered foam dressing was applied which was inconsistent. On 10/29/24 at 1118 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. cross reference: Tag G - 580 6. Review of Patient 8's clinical record was initiated on 10/23/24. The closed clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification period from 8/19/24 to 10/17/24 and 10/18/24 to 12/16/24. Review of the Resumption of Care Orders dated 9/20/24, cited SN visits daily until 10/1/24 for continue assessment of patients overall condition. SN to perform treatment and dressing to the patients right abdominal area drain site, buttocks extending to the perineal area blanchable redness, and left second toe open blister. Review of the SN notes dated 9/22, 9/23, 9/24, 9/25, 9/26, 9/27 and 9/28/24 showed the SN had performed body system assessment. The assessment includes Wound Type. The section on wound type showed patient was assessed to have a "stage 2 pressure injury" and a check mark on "see wound sheet assessment and treatment". However, review of the SN notes failed to show documented evidenced of the wound assessment for the patients "stage 2 pressure injury ". On 10/29/24 at 1530 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged 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 HHA’s RN provided supervision to the LVN to ensure quality of care and services were provided for one of 12 sampled patients (Patient 10), creating the risk of substandard health outcomes to this patient. Findings: Review of Patient 10's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/6/23. The patient was certified for home health services during the certification period from 8/31/24 to 10/29/24. Review of the clinical record for Patient 10 showed the LVN did not provide services in accordance with the POC for this patient. Cross reference to G710, example #7. The LVN Supervisory Note dated 9/11 and 10/2/24, showed the RN had conducted a supervisory visit and the LVN followed the plan of treatment. * However, the RN failed to identify the LVN did not provide services in accordance with the POC. On 10/29/24 at 1010 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the finding.

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 patient care instructions for the CHHA was developed by the RN who was responsible for the supervision of the CHHA for one of 12 patients (Patient 3). This failure had the potential for not addressing the care needs for this patient. Findings: Review of Patient 3's closed clinical record was initiated on 10/23/24, and showed the SOC was 7/26/23. The patient was certified for home health services during the certification periods from 9/26/23 to 11/24/23, and 11/25/23 to 1/23/24. The physician’s order dated 9/23/23, showed to recertify the patient for certification period 9/26/23 to 11/24/23. The physician’s order included CHHA visits 1W9 to assist the patient with ADL personal care and hygiene, grooming, bathing, and light house keeping. The CHHA visit note dated 10/3/23, showed temperature, pulse rate, respiratory rate and BP were obtained. Documentation showed the patient was provided complete bed bath, personal care, assisted with dressing, hair care, skin care, foot care, pressure areas checked, assisted with bed mobility, encouraged fluids, and recorded patient's last BM. On 10/29/24 at 1043 hours, an interview and concurrent closed clinical record review was conducted with the DPCS. The DPCS stated there should be a CHHA care plan on what specific tasks the CHHA was to perform. The DPCS stated there was no CHHA care plan for the patient. The DPCS was informed and acknowledged the finding.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on interview and record review, the Administrator failed to ensure the HHA employed a qualified personnel (RN 2). This failure had the potential for substandard care provided. Findings: The agency’s P&P titled Executive Director/Administrator dated 4/2014, showed the essential job functions/responsibilities include recruiting, employing, and retaining qualified personnel to maintain appropriate staffing levels; and ensuring organizational compliance with legal, regulatory, and accreditation standards. The Executive Director/Administrator is responsible for planning, coordinating, managing, and directing all activities, and programs of the HHA. According to Title 22 Section 74707 (c) A registered nurse shall perform duties consistent with the Nursing Practice Act including the Standards of Competent Performance, Title 16, Chapter 14, Section 1443.5 of the California Code of Regulations. A registered nurse shall meet qualifications established by the home health agency for the services provided and any additional qualifications required by home health agency licensure regulations. Effective January 1, 1998, registered nurses providing services in a patient's temporary or permanent place of residence through a home health agency shall have one-year prior professional nursing experience. Review of the personnel files was conducted on 10/28/24. RN 2's personal file showed RN 2 was hired on 7/31/23. RN 2’s resume showed the work experience included as a charge nurse in a dialysis facility from 2009 to 2013, charge nurse in a dialysis health care from 2014 to 2015, supervisor in a SNF from 2016 to 2018; and a President/CEO in a home care company from 2012 to 2020. * However, there was no documented evidence RN 2 had a one-year prior professional nursing experience as per Title 22. On 10/29/24 at 1106 hours, an interview and concurrent record review was conducted with the Human Resource Staff. The Human Resource Staff was informed and acknowledged the finding.

Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the rehabilitation services were provided timely as per the contract agreement for two of the 12 sampled patients (Patient 8 and 12). This failure had the potential for not identifying and addressing the care needs timely for these patients. Findings: Review of the agency's P&P titled Care Coordination revised 4/14, showed timely and ongoing communication is the responsibility of each team member, will be appropriate to the needs and abilities of the patient, and will be relevant to the care of the patient. Care coordination will include timely documentation of coordination of care services. Review of the contract titled Independent Contractor Agreement for Home Health Services dated 4/1/24, showed the therapy staff shall perform the initial evaluation or assessment within 72 hours from the time the therapy staff is notified of the order for consultation. Review of Patient 12's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 10/1/24. The patient was certified for home health services during the certification period from 10/1/24 to 11/29/24. The POC, for the certification period from 10/1/24 to 11/29/24, cited a PT evaluation. Review of the PT evaluation note dated 10/8/24, showed the PT had performed the evaluation, more than 72 hours after it was ordered. On 10/29/24 at 1108 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was asked about the timeframe for the PT evaluation. The DPCS replied it should be within 48 hours from the physicians order. The DPCS further stated it was late and there was no coordination notes. The DPCS was informed and acknowledged the finding. 2. Review of Patient 8's clinical record was initiated on 10/23/24. The clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification periods from 8/19/24 to 10/17/24, and 10/18/24 to 12/16/24. Review of the POC, for the certification period from 8/19/24 to 10/17/24, showed an order for RT evaluation/visit to asses patients cardiorespiratory status due to pneumonia and recent exacerbation of SOB. However, review of the clinical record failed to show documented evidence of RT evaluation/visit was conducted within 72 hours as per the contract agreement. In addition, review of the physicians order dated 9/6/24, showed an order for RT evaluation/visit to asses patients cardiorespiratory status due to pneumonia and recent exacerbation of SOB. However, review of the clinical record failed to show documented evidence of a RT evaluation/visit was conducted within 72 hours as per the contract agreement. On 10/29/24 at 1530 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on interview and record review and interview, the agency failed to ensure the implementation of the P&Ps related to wound photography for four of 12 sampled patients (Patient 1, 4, 7, 8 and 10); and employee TB screening for one of five employees (RN 2). This failure had the potential for not addressing the care needs for the patients. e. Review of Patient 10's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/6/23. The patient was certified for home health services during the certification period from 8/31/24 to 10/29/24. The recertification assessment dated 8/26/24, showed the patient had Stage 1 coccyx pressure injury. The SN note during Week 2 (9/1/24 to 9/7/24), showed the patient had redness on the coccyx area. * However, there was no documented evidence of a wound photograph for the redness to the coccyx area on Week 2. The recertification assessment dated 8/26/24, showed the patient had non-pressure chronic ulcer to the right distolateral extremity. The physician’s order dated 10/11/24, showed the non-pressure chronic ulcer to the right distolateral extremity was resolved. * However, there was no documented evidence of wound photograph for Week 2 (9/1/24 to 9/7/24), Week 3 (9/8/24 to 9/14/24), Week 5 (9/22/24 to 9/28/24), and Week 6 (9/29/24 to 10/5/24). On 10/29/24 at 1010 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 2. The P&P titled Selection/Hiring of Personnel revised date 01/2022, showed a written health assessment and TB test/chest x-ray must be performed within 6 months prior to employment or within 15 days after assuming employment with the agency to be submitted immediately upon receipt. RN 2 was hired on 7/31/23. However, the TB test was completed on 10/19/23, more than 15 days of assuming employment. On 10/29/24 at 1109 hours, an interview and concurrent record review was conducted with the Human Resource Staff. The Human Resource Staff was informed and acknowledged the findings. 1.Review of the agency's P&P titled Wound Assessment and Documentation revised 1/2022, showed the photo documentation guidelines includes to take photographs on admission, once a week, upon discovery, change in wound status and upon discharge (if wound is still present). a. Review of Patient 1's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 3/25/24. The patient was certified for home health services during the certification periods from 3/25/24 to 5/23/24. The patient was discharge from the agency on 5/17/24. *Review of the SOC OASIS dated 3/25/24, showed the RN performed an assessment to the patients stage 2 pressure injury to the sacral area. However, the RN failed to take photograph upon admission of the patients stage 2 pressure injury to the sacral area as per P&P. The POC, for the certification period from 3/25/24 to 5/23/24, cited SN visits 2W2 (two times a week for two weeks),1W7. The POC showed SN to assess wound status, size, depth, drainage, color, presence or absence of necrotic tissue, surrounding skin, signs and symptoms of infections and complications in wound healing. *Review of the SN visit notes dated 3/28, 4/3, 4/9, 4/18 and 5/9/24, showed the SN had performed body system assessment. The assessment includes Wound Type. The wound type was documented as decubitus stage 2. However, review of the closed medical record failed to show documented evidence of a wound photograph was taken weekly per P&P. On 10/29/24 at 1203 hours, an interview and concurrent closed medical record review was conducted with the DPCS. The DPCS was asked if the wound photographs were taken as per P&P. The DPCS checked the SN visit notes and replied, no. The DPCS was informed and acknowledged the findings. b. Review of Patient 4's clinical record was initiated on 10/25/24. The closed clinical record showed the SOC was 11/11/22. The patient was certified for home health services during the certification period from 9/1/24 to 10/30/24. The POC for the certification periods from 9/1/24 to 10/30/24 cited SN visits 1W1 for all body system assessments. Review of the SN notes dated 9/5, 9/10, 9/17, 9/24, 9/30/24 showed the SN had performed wound assessment and treatment to the patients stage 2 pressure injury to the right buttocks. The assessment includes a section if a wound photograph was taken. The SN marked yes on the section if the photo was taken. In addition, review of the SN notes dated 10/5/24 on the section of narrative notes showed the patients stage 2 pressure injury to the right buttocks was healed. However, review of the clinical record failed to show documented evidenced of the wound photographs were taken weekly and when it was healed as per P&P. On 10/29/24 at 1338 hours, an interview and concurrent closed medical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. c. Review of Patient 7's clinical record was initiated on 10/24/24. The clinical record showed the SOC was 8/5/24. The patient was certified for home health services during the certification period from 8/5/24 to 10/3/24 and 10/4/24 to 12/2/24. The POC for the certification periods from 8/5/24 to 10/3/24, cited SN visits 3W8 for assessment of all body system. The POC also showed SN to perform treatment to the patients diabetic ulcer to the left heel. Review of the SN notes dated 8/14, 8/21 and 9/14/24 showed the SN had performed wound assessment and treatment to the patients diabetic ulcer to the left heel. The assessment showed photo was taken. However, review of the clinical record failed to show documented evidenced of a wound photograph was taken weekly as per P&P. On 10/29/24 at 1131 hours, an interview and concurrent closed medical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. Crossed ref: G-716 d. Review of Patient 8's clinical record was initiated on 10/23/24. The closed clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification period from 8/19/24 to 10/17/24 and 10/18/24 to 12/16/24. Review of the Resumption of Care (after Inpatient stay) dated 9/17/24 on the section of Wound/Lesion showed the patient was assessed to have redness to the bilateral buttocks, open blister on the left second toe, stage 2 pressure injury to the sacrococcygeal area and abrasion to the right anterior leg. Review of the SN notes dated 9/22, 9/23, 9/24, 9/25, 9/26, 9/27 and 928/24, showed the SN had performed wound treatment. However, review of the clinical record failed to show documented evidenced of the wound photographs were taken weekly as per P&P. On 10/29/24 at 1530 hours, an interview and concurrent closed medical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. Findings: 1. Review of the agency's P&P titled Wound Assessment and Documentation revised 1/2022 showed the photo documentation guidelines includes to take photographs on admission, once a week, upon discovery, change in wound status, and upon discharge (if wound is still present). a. Review of Patient 1's closed clinical record was initiated on 10/22/24. The closed clinical record showed the SOC was 3/25/24. The patient was certified for home health services during the certification period from 3/25/24 to 5/23/24. The patient was discharged from the agency on 5/17/24. Review of the SOC OASIS dated 3/25/24, showed the RN performed an assessment to the patient's Stage 2 pressure injury to the sacral area. However, the RN failed to take photograph of the patient's Stage 2 pressure injury to the sacral area upon admission as per the agency's P&P. The POC, for the certification period from 3/25/24 to 5/23/24, cited SN visits 2W2 and 1W7. The POC cited SN to assess wound status, size, depth, drainage, color, presence or absence of necrotic tissue, surrounding skin, signs and symptoms of infections, and complications in wound healing. Review of the SN visit notes dated 3/28, 4/3, 4/9, 4/18 and 5/9/24, showed the SN had performed body system assessment. The assessment included the wound type which was documented as decubitus (pressure injury) Stage 2. However, review of the closed clinical record failed to show documented evidence of the wound photograph obtained weekly as per the agency's P&P. On 10/29/24 at 1203 hours, an interview and concurrent closed medical record review was conducted with the DPCS. The DPCS was asked if the wound photographs were taken as per the agency's P&P. The DPCS checked the SN visit notes and replied no. The DPCS was informed and acknowledged the findings. b. Review of Patient 4's clinical record was initiated on 10/25/24. The clinical record showed the SOC was 11/11/22. The patient was certified for home health services during the certification period from 9/1/24 to 10/30/24. The POC, for the certification period from 9/1/24 to 10/30/24, cited SN visits 1W1 for all body system assessments. Review of the SN notes dated 9/5, 9/10, 9/17, 9/24, 9/30/24, showed the SN had performed wound assessment and treatment to the patient's Stage 2 pressure injury to the right buttocks. The assessment included a section to document if a wound photograph was taken, which the SN marked yes for the photograph was taken. In addition, review of the SN notes, on the narrative section, dated 10/5/24, showed the patient's Stage 2 pressure injury to the right buttocks was healed. However, review of the clinical record failed to show documented evidence the wound photographs were taken weekly and when it was healed as per the agency's P&P. On 10/29/24 at 1338 hours, an interview and concurrent medical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. c. Review of Patient 7's clinical record was initiated on 10/24/24. The clinical record showed the SOC was 8/5/24. The patient was certified for home health services during the certification periods from 8/5/24 to 10/3/24 and 10/4/24 to 12/2/24. The POC, for the certification periods from 8/5/24 to 10/3/24, cited SN visits 3W8 for assessment of all body system. The POC also showed SN to perform treatment to the patient's diabetic ulcer to the left heel. Review of the SN notes dated 8/14, 8/21 and 9/14/24, showed the SN had performed wound assessment and treatment to the patient's diabetic ulcer to the left heel. The assessment showed a photograph was taken. However, review of the clinical record failed to show documented evidence the wound photographs were taken weekly as per the agency's P&P. On 10/29/24 at 1131 hours, an interview and concurrent closed medical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. d. Review of Patient 8's clinical record was initiated on 10/23/24. The clinical record showed the SOC was 8/19/24. The patient was certified for home health services during the certification periods from 8/19/24 to 10/17/24, and 10/18/24 to 12/16/24. Review of the Resumption of Care (after Inpatient stay), on the section of Wound/Lesion dated 9/17/24, showed the patient was assessed to have redness to the bilateral buttocks, open blister on the left second toe, stage 2 pressure injury to the sacrococcygeal area and abrasion to the right anterior leg. Review of the SN notes dated 9/22, 9/23, 9/24, 9/25, 9/26, 9/27 and 928/24, showed the SN had performed wound treatment. However, review of the clinical record failed to show documented evidence the wound photographs were taken weekly as per the agency's P&P. On 10/29/24 at 1530 hours, an interview and concurrent medical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. e. Review of Patient 10's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/6/23. The patient was certified for home health services during the certification period from 8/31/24 to 10/29/24. The recertification assessment dated 8/26/24, showed the patient had Stage 1 coccyx pressure injury. The SN note during Week 2 (9/1/24 to 9/7/24), showed the patient had redness on the coccyx area. * However, there was no documented evidence of a wound photograph for the coccyx redness area during Week 2. The recertification assessment dated 8/26/24, showed the patient had non-pressure chronic ulcer to the right distolateral extremity. The physician’s order dated 10/11/24, showed the non-pressure chronic ulcer to the right distolateral extremity was resolved. * However, there was no documented evidence of wound photograph for Week 2 (9/1/24 to 9/7/24), Week 3 (9/8/24 to 9/14/24), Week 5 (9/22/24 to 9/28/24), and Week 6 (9/29/24 to 10/5/24). On 10/29/24 at 1010 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 2. The agency's P&P titled Selection/Hiring of Personnel revised date 01/2022, showed a written health assessment and TB test/chest x-ray must be performed within six months prior to employment or within 15 days after assuming employment with the agency to be submitted immediately upon receipt. Review of RN 2's personnel file showed RN 2 was hired on 7/31/23. However, the TB test was completed on 10/19/23, more than 15 days of assuming employment. On 10/29/24 at 1109 hours, an interview and concurrent agency documented review was conducted with the Human Resource Staff. The Human Resource Staff was informed and acknowledged 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 provide completed discharge summaries within five days from the date of discharge for three of three discharged patients (Patient 1, 2, and 3). This failure had the potential for the physician not aware of the patient's condition at discharge. 3. Review of Patient 3's closed clinical record was initiated on 10/23/24. The clinical record showed the SOC was 7/26/23. The patient was certified for home health services during the certification periods from 9/26/23 to 11/24/23 and 11/25/23 to 1/23/24. The POC, for the certification period from 11/25/23 to 1/23/24, showed the patient’s medications included quetiapine fumarate (antipsychotic) 50 mg 1 tablet oral TID, divalproex (anticonvulsant) 125 mg DR one capsule oral BID, donepezil (cognition enhancing medication) 5mg one tablet oral daily, aspirin (nonsteroidal anti-inflammatory drug) 81mg one tablet oral daily, multivitamin (supplement) two gummies oral daily, trazadone (antidepressant) 100mg one tablet oral Q HS, memantine HCL (cognition enhancing medication) 10 mg one tablet oral BID, melatonin (supplement) 10 mg one tablet oral Q HS PRN for sleep, acetaminophen (analgesic) 325 mg two tablets oral every four hours PRN for pain, Albuterol (bronchodilator) 90 mcg/puff inhaler two puffs every 4 hours PRN Q four hours PRN for SOB/wheezing, dextromethorphan /guaifenesin (cough suppressant/expectorant) 10/100 mg/5 ml 5-10 ml Q six hours PRN for cough, ondansetron (antiemetic) 4 mg one tablet Q 6 hours as needed for nausea and vomiting, and senna (laxative) 8.6 mg two tablets oral at night as needed for constipation The discharge assessment dated 1/20/24, showed the patient was discharged. * The Discharge Summary dated “1/20,” showed no documented evidence the medications the patient was on at the time of discharge was included in the discharge summary. In addition, there was no documented evidence the discharge summary was sent to the primary care physician who will be responsible for providing care and services to the patient after discharge from the HHA within five business days of the patient’s discharge. On 10/29/24 at 1043 hours, an interview and concurrent record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 1.Review of Patient 1's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 3/25/24. The patient was certified for home health services during the certification periods from 3/25/24 to 5/23/24. The patient was discharge from the agency on 5/17/24. Review of the Physicians order dated 5/17/24, showed an order for discharge from the agency per patients request. Review of the Discharge Summary dated 5/17/24, showed the RN had provided the discharge instructions via telephone. The RN have notified the patient, family and the MD of services have been terminated. Family/PCG will assume responsibility. However, review of the medical record failed to show documented evidenced of the discharge summary was sent to the physician five days from the date of discharge. On 10/29/24 at 1203 hours, an interview and concurrent closed medical record review was conducted with the DPCS. The DPCS was asked if the discharge summary was sent to MD within five days from the date of discharge. The DPCS replied, no, it was not sent to MD within five days but available upon request. The DPCS was informed and acknowledged the findings. 2. Review of Patient 2's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 5/1/24. The patient was certified for home health services during the certification periods from 5/1/24 to 6/29/24 and 6/30/24 to 8/28/24. The patient was discharge from the agency on 8/22/24. Review of the Physicians order dated 8/22/24, showed an order for discharge from the agency with instructions to follow up with PCP. Discharge summary is available upon request. Review of the Discharge Summary dated 8/22/24, showed the RN had provided the discharge instructions. The RN have notified the patient, family and the MD of services have been terminated. Family/PCG will assume responsibility. However, review of the medical record failed to show documented evidenced of the discharge summary was sent to the physician five days from the date of discharge. On 10/29/24 at 1231 hours, an interview and concurrent closed medical record review was conducted with the DPCS. The DPCS was asked if the discharge summary was sent to MD within five days from the date of discharge. The DPCS replied, no, it was not sent to MD within five days but available upon request. The DPCS was informed and acknowledged 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 authenticate the entries made in the clinical records for two of 12 patients (Patients 3 and 10). This failure had the potential for not knowing who provided care to the patients. Findings: The agency’s P&P titled Entries Into The Clinical record dated 4/2014 showed signature authorization of the clinical documentation will include the staff member’s name and credentials (as specified on professional licenses and/or certification documents). All entries into the clinical record will reflect the date care was provided, including the month, date, and year. 1. Review of Patient 10's clinical record was initiated on 10/22/24. The clinical record showed the SOC was 9/6/23. The patient was certified for home health services during the certification period from 8/31/24 to 10/29/24. The SN notes dated 9/11/and 9/18/24, showed the LVN conducted a visit. * However, there was no documented evidence of the clinician’s electronic signature, date, and credential. On 10/29/24 at 1010 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 2. Review of Patient 3's closed clinical record was initiated on 10/23/24. The closed clinical record showed the SOC was 7/26/23. The patient was certified for home health services during the certification periods from 9/26/23 to 11/24/23 and 11/25/23 to 1/23/24. The SN note dated 11/15/23, showed the LVN conducted a visit. * However, there was no documented evidence of the clinician’s electronic signature, date, and credential. The PT Visit Notes dated 10/2, 10/4, 10/11, and 10/16/23, showed the PTA completed and electronically signed the note; and the PT reviewed and electronically signed the notes. * However, there was no documented evidence of the date when it was completed, reviewed, and electronically signed. The Physical Therapy Discharge Summary dated10/25/23, showed the PT had completed and electronically signed the note. * However, there was no documented evidence of the date when it was completed and electronically signed. On 10/29/24 at 1043 hours, an interview and concurrent closed clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

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; 39796, HFEN; and 39210, HFEN. The survey team entered the HHA on 12/7/21 at 1030 hours. GLOSSARY OF ABBREVIATIONS AND BRIEF DEFINITION: COVID-19: an infectious disease caused by the SARS-CoV-2 virus DPCS: Director of Patient Care HHA: Home Health Agency P&P: Policy and Procedure Q: every

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on document review and interview, the agency failed to ensure the emergency preparedness plan was reviewed and updated every two years, creating the increased risk of not addressing the care needs for the patients of the agency during the emergency events. Review of the agency's emergency preparedness plan was conducted on 12/13/21. The agency's emergency preparedness plan updated date 10/28/21, showed the emergency preparedness plan was reviewed and approved by the Administrator, DPCS, Agency Emergency Coordinator, and Governing Body representative on 10/28/17. However, there was no documented evidence the emergency preparedness plan was reviewed and updated every two years. On 12/15/21 at 1530 hours, the DPCS was informed and acknowledged the findings.

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), §485.625(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 document review and interview, the agency failed to ensure the emergency preparedness plan included the strategies addressing the emergency events identified by the risk assessment, creating the increased risk of not addressing the care needs for the patients during the emergency events. Review of the agency's emergency preparedness plan was conducted on 12/13/21. The agency's emergency preparedness plan showed the events identified on the hazard vulnerability assessment included communication/telephony failure, drought, earthquake, epidemic/pandemic, external flood, fire/wild fire, infectious disease outbreak/COVID-19, landslide, seasonal influenza, and tsunami. However, there were no documented evidence of the strategies to address the emergency events related to communication/telephony failure, drought, infectious disease outbreak, and seasonal influenza. On 12/15/21 at 1530 hours, the DPCS 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), §485.625(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 document review and interview, the agency failed to ensure the emergency preparedness plan included the updated information addressing the patient population and type of services to be provided in an emergency, creating the risk of not providing appropriate, consistent, and quality care to the patients. Review of the agency's emergency preparedness plan was conducted on 12/13/21. However, the agency's emergency preparedness plan was not updated to address the current patient population and type of services to be provided in an emergency. On 12/15/21 at 1530 hours, the DPCS was informed and acknowledged the findings.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [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. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility 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 annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization 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 address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility 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. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on document review and interview, the agency failed to ensure the emergency preparedness P&P was reviewed and updated every two years, creating the increased risk of not addressing the care needs for the patients during the emergency events. Review of the agency's emergency preparedness P&P was conducted on 12/13/21. The document dated 10/28/21, showed the emergency preparedness P&P was approved on 10/28/17. However there was no documented evidence the emergency preparedness P&P was reviewed and updated every two years. On 12/15/21 at 1530 hours, the DPCS 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 document review and interview, the agency failed to ensure the emergency preparedness P&P addressed the procedures to inform the State and local emergency preparedness officials about the patients in need of evacuation from their residences due to an emergency situation based on the patient's medical and psychiatric condition and home environment. This failure created the increased risk of not evacuating the patients timely. Review of the agency's emergency preparedness plan was conducted on 12/13/21. The emergency preparedness plan showed the patients identified as at risk for injury or inability to comply with their medical and/or psychiatric plan of care, based on triage code levels shall be reported to State and local emergency officials for possible residences. However, the emergency preparedness P&P failed to include the procedures on when and how the State and local emergency preparedness officials would be informed about the patients in need of the evacuation from their residences due to an emergency situation. On 12/15/21 at 1530 hours, the DPCS 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 document review and interview, the agency failed to ensure the emergency preparedness P&P addressed the procedures to inform the State and local officials of any on-duty staff or patients that they were unable to contact. This failure had the potential to negatively affect the patients' care needs during the emergency events. Review of the agency's emergency preparedness plan and P&P was conducted on 12/13/21, and showed the agency's emergency preparedness P&P failed to include the procedures to inform the State and local officials of any on-duty staff or patients that they were unable to contact. On 12/15/21 at 1530 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

Policies/Procedures for Medical Documentation CFR(s): 484.102(b)(4) §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This STANDARD is not met as evidenced by: Based on document review and interview, the agency failed to ensure the emergency preparedness P&P addressed a system of medical documentation that protected confidentiality of the patient information, and secured and maintained availability of records. This created the potential risk of not protecting the patient's confidential information during the emergency. Review of the agency's emergency preparedness P&P was conducted on 12/13/21. The agency's emergency preparedness P&P showed the Agency Emergency Coordinator shall ensure all medical documentation is secured in order to protect the documentation, preserve the patient's information, and make the documentation available However, the P&P did not address a system of medical documentation that protected confidentiality of patient information, and secured and maintained availability of records. On 12/15/21 at 1530 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. This STANDARD is not met as evidenced by: Based on document review and interview, the agency failed to ensure the emergency preparedness communication plan was reviewed and updated every two years, creating the increased risk of not addressing the care needs for the patients during the emergency events. Review of the agency's emergency preparedness communication plan was conducted on 12/13/21, and showed no documented evidence the emergency preparedness communication plan was reviewed and updated Q two years. On 12/15/21 at 1530 hours, an interview and concurrent document review was conducted with the DPCS. The DPCS 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), §485.625(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 document review and interview, the agency failed to ensure the emergency preparedness communication plan included the updated name and contact information of the staff, entities provided services under agreement, patients' physician, and volunteers. This failure had the potential to negatively impact the patients' care needs during the emergency events. Review of the agency's emergency preparedness communication plan was conducted on 12/13/21. The agency's emergency preparedness communication plan showed the document dated 10/19, addressing the name and contact information of the staff, entities provided services under agreement, patients' physician, and volunteers. However, the information was not updated to address current name and contact information of the staff, entities provided services under agreement, patients' physician, and volunteers. On 12/15/21 at 1530 hours, the DPCS 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), §485.625(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 document review and interview, the agency failed to ensure the emergency preparedness communication plan included the information related to the alternate means for communicating with staff, federal, state, regional and local emergency management agencies, creating the risk of not being able to communicate to meet the patient and staff needs during an emergency. Review of the agency's emergency preparedness communication plan was conducted on 12/13/21. The agency's emergency preparedness communication plan showed if phones were not available, the Emergency Coordinator will contact two prearranged radio stations. The communication plan also showed, "Insert Two Radio Identification Letter/Number Combination" with an announcement for staff and patient. However, there was no information on what the two radio identification/letter number combination were. On 12/15/21 at 1530 hours, the DPCS was informed and acknowledged the findings.

Methods for Sharing Information CFR(s): 484.102(c)(4)-(5) §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(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: (4) A method for sharing information and medical documentation for patients under the [facility's] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility's] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI's care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4). This STANDARD is not met as evidenced by: Based on document review and interview, the agency failed to ensure the emergency preparedness communication plan included the method for sharing information and medical documentation for the HHA's patients with other health providers to maintain the continuity of care, creating the increased risk of not providing appropriate, consistent, and quality care to the patients during the emergency events. Review of the agency's emergency preparedness plan was conducted on 12/13/21. The agency's emergency preparedness communication plan failed to include the method for sharing the information and medical documentation for the HHA's patients with other health providers to maintain the continuity of care. On 12/15/21 at 1530 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS 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), §485.625(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 document review and interview, the agency failed to ensure the emergency preparedness communication plan included a means of providing information about the agency's occupancy, needs, and its ability to provide assistance to the authority having jurisdiction, the Incident Command Center, or designee. This failure created the risk of not providing the necessary care and services to the patients during the emergency events. Review of the agency's emergency preparedness plan and P&P was conducted on 12/13/21. The P&P showed the emergency preparedness communication plan did not include a means of providing information about the agency's occupancy, needs, and its ability to provide assistance to the authority having jurisdiction, the Incident Command Center, or designee. On 12/15/21 at 1315 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on document review and interview, the agency failed to ensure the emergency preparedness training and testing program was reviewed and updated every two years, creating the increased risk of not addressing the care needs for the patients during the emergency events. Review of the agency's emergency preparedness training and testing program was conducted on 12/13/21. However, there was no documented evidence the emergency preparedness training and testing program were reviewed and updated every two years. On 12/15/21 at 1530 hours, an interview and concurrent document review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on document review and interview, the agency failed to ensure the initial training in the emergency preparedness program was provided to contracted individuals providing services under arrangement. This failure created the risk of the HHA's staff not knowing what to do in case of emergency. Review of the agency's emergency preparedness plan and P&P was conducted on 12/13/21. The agency's emergency preparedness plan and P&P showed no documented evidence of the initial training in the emergency preparedness program provided to the contracted individuals providing services under arrangement. On 12/15/21 at 1530 hours, an interview and concurrent document review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on document review and interview, the agency failed to ensure the HHA had conducted exercises to test the emergency plan annually. This failure created the risk of the HHA's staff not knowing what to do in case of emergency. Review of the agency's emergency preparedness testing and training documents was conducted on 12/13/21. The agency's emergency preparedness testing and training documents showed a "Tabletop emergency drill" was conducted on 10/31/19 and 10/29/21. However, there was no documented evidence the HHA had conducted exercises to test the emergency plan for the year 2020. On 12/15/21 at 1530 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS 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; 39796, HFEN; and 39210, HFEN. The survey team entered the HHA on 12/7/21 at 1030 hours. The survey team conducted 4 home visits and reviewed 7 active and 3 closed clinical records. GLOSSARY OF ABBREVIATIONS AND BRIEF DEFINITIONS: ADL: Activities of Daily Living AM: Morning BID: Twice a Day BP: Blood Pressure BS: blood sugar CDC: Centers for Disease Control and Prevention CEO: Chief Executive Officer CHHA: Certified Home Health Aide CLIA: Clinical Laboratory Improvement Amendments COVID-19: an infectious disease caused by the SARS-CoV-2 virus DBP: diastolic blood pressure (the pressure in the arteries when the heart rests between beats) dl: deciliter DPCS: Director of Patient Service ER: Extended Release gm: gram(s) G-Tube: gastric tube (a tube inserted through the wall of the abdomen directly into the stomach. It allows air and fluid to leave the stomach and can be used to give drugs and liquids, including liquid food, to the patient) HHN: hand held nebulizer HR: Human Resource hrs: hours HS: at bedtime Hyperglycemic: high blood sugar Hypoglygemic: low blood sugar IM: Intramuscular Interstitial infiltrate: the accumulation of foreign and/or abnormal substances (i.e pus, blood, fluid) within body tissues or cells in the interstitium (lining between the air sacs) IV: Intravenous LVN: Licensed Vocational Nurse mcg: microgram(s) MD: Medical Doctor meq: milliequivalent(s) mg: milligram(s) mmHg: millimeter(s) of mercury ml: milliliter(s) MSW: Medical Social Worker NS: Normal Saline OASIS: Outcome and Assessment Information Set OT: Occupational Therapy/Therapist oz: ounce(s) P&P: Policy and Procedure PCG: Primary Caregiver PCP: Primary Care Provider Pneumonia: an infection of one or both of the lungs caused by bacteria, viruses, or fungi PO: By mouth POC: Plan of Care PRN: As Needed PT: Physical Therapy/Therapist PTA: Physical Therapy Assistant Q: Every QAPI: Quality Assurance Performance Improvement QD: Daily rales: small clicking, bubbling, or rattling sounds in the lungs RN: Registered Nurse Sacrum: a shield-shaped bony structure that is located at the base of the lumbar vertebrae and that is connected to the pelvis SBP: systolic blood pressure (how much pressure your blood is exerting against your artery walls when the heart beats) SC: Subcuteneous SN: Skilled Nursing/Nurse SOC: Start of Care ST: Speech Therapy/Therapist Stage 1 pressure injury: intact skin with non-blanchable redness of a localized area usually over a bony prominence. Darkly pigmented skin may not have visible blanching; its color may differ from the surrounding area. 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 Stage 3 pressure injury: full-thickness skin loss; full-thickness loss of skin, in which adipose (fat) is visible in the ulcer and granulation tissue and epibole (rolled wound edges) are often present. TID: Three Times a Day u: unit(s) W: Week

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 clinical 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, but no later than 5 calendar days after the SOC date for seven of 10 sampled patients (Patients 1, 3, 4, 5, 7, 8, and 10), creating the risk of not identifying and addressing the care needs timely for these patients. Findings: 5. Review of Patient 5's clinical record was initiated on 12/8/21. The clinical record showed the SOC was 11/12/21. The patient was certified for home health services during the certification period from 11/12/21 to 1/10/22. The initial comprehensive assessment dated 11/12/21, showed the RN had performed the initial comprehensive assessment. However, there was no documented evidence of the hand grips assessment and advance directives status. On 12/15/21 at 1349 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was informed and acknowledged the findings. 6. Review of Patient's 8 clinical record was initiated on 12/10/21. The clinical record showed the SOC was 4/20/21. The patient was certified for home health services during the certification periods from 4/20/21 to 6/18/2, 6/19/21 to 8/17/21, 8/18/21 to 10/16/21, and 10/17/21 to 12/15/21. a. The initial comprehensive assessment dated 4/2021, showed the RN had performed the initial comprehensive assessment. However, the initial comprehensive assessment showed no documented evidence of the hand grips assessment and advance directive status. b. Review of the recertification comprehensive assessment dated 10/15/21, showed the RN had performed the recertification comprehensive assessment. However, the recertification comprehensive assessment showed the Advance Directive, Integumentary system and the Psychosocial were assessed. On 12/15/21 at 1255 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was informed and acknowledged the findings. 7. Review of Patient 10's clinical record was initiated on 12/10/21. The clinical record showed the SOC was 3/22/20. The patient was certified for home health services during the certification periods from 9/13/21 to 11/11/21, and 11/12/21 to 1/10/22. The POC for the certification period from 9/13/21 to 11/11/21 and 11/12/21 to 1/10/22, cited for SN visits 1W9 (one visit a week for nine weeks) for the assessments of all the body systems. Further review of the POC showed Patient 10's other pertinent diagnoses included hemiplegia, unspecified affecting the left nondominant side. The recertification comprehensive assessment dated 9/9/21, showed the RN had performed the comprehensive assessment. However, there were no assessments of the musculoskeletal system for the hand grips, dominant side, weakness; and advance directives status. On 12/15/21 at 1236 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was informed and acknowledged the findings. 4. Closed clinical record review for Patient 1 was initiated on 12/9/21. The clinical record showed the SOC was 2/22/21. The patient was certified for home health services during the certification period from 2/22/21 to 4/22/21. Review of Patient 1's initial comprehensive assessment dated 2/22/21, showed no documented evidence of the complete assessment of the patient's mouth and advance directive status. On 12/15/21 at 1202 hours, an interview and concurrent medical record review was conducted with LVN 3. LVN 3 was informed and acknowledged the findings. 1. Review of Patient 4's clinical record was initiated on 12/7/21. The clinical record showed the SOC was 10/10/21. The patient was certified for home health services during the certification period from 10/10/21 to 12/8/21. The initial comprehensive assessment dated 10/10/21, showed the RN had performed the initial comprehensive assessment. However, there was no documented evidence the patient's hand grips were assessed. On 12/15/21 at 1209 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 2. Review of Patient 7's clinical record was initiated on 12/9/21. The clinical record showed the SOC was 10/22/21. The patient was certified for home health services during the certification period from 10/22/21 to 12/20/21. The initial comprehensive assessment dated 10/22/21, showed the RN had performed the initial comprehensive assessment. However, there was no documented evidence the patient's hand grips were assessed. On 12/15/21 at 1230 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 3. Review of Patient 3's closed clinical record was initiated on 12/9/21. The closed clinical record showed the SOC was 10/1/21. The patient was certified for home health services during the certification period from 10/1/21 to 11/29/21. The initial comprehensive assessment dated 10/1/21, showed the RN had performed the initial comprehensive assessment. However, there was no documented evidence the patient's hand grips were assessed. In addition, there was no documented evidence the patient's psychosocial status was completed. On 12/15/21 at 1315 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the finding.

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 clinical record review, the agency failed to ensure the medication profiles were updated for seven of 10 sampled patients (Patients 2, 4, 5, 6, 7, 8, and 10), creating the risk of not identifying the potential adverse effects, significant drug interactions, duplicate drug therapy, and drug reactions for these patients. 7. Review of Patient 6's clinical record was initiated on 12/8/21. The clinical record showed the SOC for Patient 6 was on 1/19/21. The patient was certified for home health services during the certification period from 11/15/21 to 1/13/22. The Medication Profile showed the patient's medications included levothyroxine (hypothyroidism) 50 mcg one tablet PO QD, Omeprazole (to treat acid reflux) 20 mg one capsule PO QD, Prednisone (corticosteroid) 5 mg one tablet PO QD, Metformin (antidiabetic) 500 mg one tablet PO BID, Metoprolol Succinate (high blood pressure) 25 mg one tab PO QD, Centrum Silver (supplement) one tablet PO QD, Folic Acid (supplement) 1mg one tablet PO QD, Gabapentin (anticonvulsant) 100 mg one capsule PO QID; Bethanecol 25 mg one tablet PO QD, Fish Oil (supplement) 1000 mg one tablet PO QD, Atorvastatin (high cholesterol) 40 mg one tablet PO QD, Sertraline (antidepressant) 50 mg one tablet PO Q HS, Tamsulosin (treatment for benign prostatic hyperplasia) 0.4 mg one tablet PO QD, and Melatonin (insomnia) 10 mg one tablet PO Q HS. A joint home visit with the CHHA was conducted on 12/8/21 at 1045 hours, to Patient 6's home. Review of the patient's medications with the family member showed Patient 6 was on Bethancol 25 mg three times a day PO, Fish Oil 1200 mg PO QD, Sertraline 25 mg one tablet PO QD, and Restasis 0.05% eye drops one drop to both eyes BID, which were not listed on the medication profile. However, the agency's SN failed to update the Medication Profile to reflect the patient's current medications. On 12/15/21 at 1202 hours, an interview and clinical record review was conducted with LVN 3. LVN 3 was informed and acknowledged the above findings. 5. Review of Patient 4's clinical record was initiated on 12/7/21. The clinical record showed the SOC was 10/10/21. The patient was certified for home health services during the certification period from 10/10/21 to 12/8/21. The Medication Profile for the certification period from 10/10/21 to 12/8/21, showed the patient's medications included metoprolol (antihypertensive) 25 mg one tablet PO BID; amiodarone (antiarrhythmic) 200 mg one tablet PO QD, Semglee (antidiabetic) 20 units injectible, inject SC per sliding scale at bedtime 0-70 = 0 units; 151-200 = 2 units, 201-250 = 4 units, 251-300 = 6 units, and 301-400 = 8 units; duloxetine (antidepressant) DR 30 mg one capsule BID; potassium (supplement) 20 meq one tablet PO QD; furosemide (antihypertensive/diuretic) 20 mg one tab PO QD; sevelamer (phosphate binder) 800 mg two tablets PO TID; Eliquis (anticoagulant) 2.5 mg one tablet PO BID; Humulin R (antidiabetic) 100 u/ml, inject per sliding scale 70-150 = 0 u, 151-200 = 1 unit, 201-250 = 2 units, 251-300 = 3 units, 301-350 = 4 units, 351-400 = 6 units, more than 400 = 10 units; and hydrocodone acetaminophen (opioid analgesic) 5/325 mg one tablet every four hours PRN. A joint home visit with RN 1 was conducted on 12/8/21 at 0800 hours, to Patient 4's home. Review of the patient's medications with the family member showed the following information: - The patient was on Semglee 4 units SC at HS instead of 20 units and per sliding scale. - The patient was on furosemide 20 mg one tablet BID instead of QD. The family member stated furosemide was started on July 2021. - The patient was on clopidogrel bisulfate (anticoagulant) 75 mg one tablet, which was started on 11/1/21, but not listed on the medication profile. - The patient was no longer on Eliquis after clopidogrel bisulfate was started. On 12/15/21 at 1209 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. She stated the medication profile should be updated every SN visit. 6. Review of Patient 7's clinical record was initiated on 12/9/21. The clinical record showed the SOC was 10/22/21. The patient was certified for home health services during the certification period from 10/22/21 to 12/20/21. The Medication Profile for the certification period from 10/22/21 to 12/20/21, showed the patient was on Megace (appetite stimulant) 40 mg PO BID, amlodipine (antihypertensive) 5 mg one tablet PO QD, budesonide (steroid) 0.5 mg/2 ml one unit dose via HHN BID, simvastatin (antilipemic)10 mg one tablet QD in the evening, vitamin C (supplement) 1000 mg one tablet PO QD, vitamin D3 (supplement) 1000 mcg one tablet, finesteride (urinary retention medication) 5 mg PO QD, iron (supplement) 65 mg one tablet PO QD, tamsulosin (urinary retention medication) 0.4 mg one capsule, stool softener 100 mg one tablet PO QD PRN for constipation, donepezil (cognition enhancing medication) 10 mg one tablet PO Q HS, omeprazole (used to treat heart burn) 20 mg one capsule PO QD, aspirin (nonsteroidal anti-inflammatory drug) 81 mg PO QD, hydrocodone/acetaminophen (opioid analgesic) 5-325 mg one tablet PO Q six hours PRN for severe pain, and acetaminophen (analgesic) 500 mg one tablet PO QD. A joint home visit with LVN 1 was conducted on 12/8/21 at 1300 hours, to Patient 7's home. Review of the patient's medications with the PCG showed the following information: - The patient was on budesonide (steroid) 0.5 mg/2 ml one unit dose via HHN QD instead of BID. - The patient was on stool softener 100 mg two tablet once a day instead of one tablet PO QD PRN. - The patient was on acetaminophen 500 mg two tablets PO Q four hours PRN instead of acetaminophen 500 mg one tablet PO QD On 12/15/21 at 1230 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. Findings: Review of the agency's P&P titled Medication Profile revised date April 2014 showed the patients receiving medications will have a current, accurate medication profile in the clinical record. Medication Profiles will be updated for each change to reflect current medications and new and/or discontinued medications. The procedure includes during the subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver, as well as other clinicians understand the medication regimen. 1. Review of Patient 5's clinical record was initiated on 12/8/21. The clinical record showed the SOC was 11/12/21. The patient was certified for home health services during the certification period from 11/12/21 to 1/10/22. The POC, for the certification period from 11/12/21 to 1/10/21, cited SN visits 1W1, 2W1, and 1W7 to assess the body systems. a. The Medication Profile showed the patient's medications included alendronate (osteoporosis) 10 mg one tablet PO QD before breakfast, Eliquis (anticoagulant) 10 mg one tablet PO BID, amlodipine (antihypertensive) 2.5 mg one tablet PO QD, memantine (antidementia)10 mg one tablet PO BID, montelukast (to treat asthma) 10 mg one tablet PO QD, sertraline (antidepressant) 50 mg one tablet PO QD, atorvastatin (anticholesterol) 40 mg one tablet PO QD, famotidine (histamine - 2 blocker) 20 mg one tablet PO QD, and losartan (antihypertensive) 50 mg one tablet PO QD PRN for BP >160/90 mmHg. A joint home visit with PTA 1 was conducted on 12/8/17 at 1100 hours, to Patient 5's home. Review of the patient's medications with PTA 1 and the PCG showed the following information: - The patient was on memantine (dementia) 5 mg one tablet PO BID instead of 10 mg one tablet PO BID. - The patient was on sertraline 50 mg one tablet PO BID instead of one tablet QD. - The patient was on atorvastatin 40 mg one tablet PO HS instead of QD. - The patient was on famotidine 20 mg one tablet PO BID instead of QD. - The patient was on losartan (antihypertensive) 50 mg one tablet PO QD PRN for BP>150/80 mmHg instead of BP >160/90 mmHg. In addition, the PCG was asked if there was any medications that the patient was taking. The PCG showed several medications that the patient was on, including Arnuity-Ellipta (inhaled corticosteroid) 100 mcg one spray Q HS, Tylenol (analgesic) 650 mg one tablet PRN for pain, Black Elderberry with vitamins C,D and Zinc (supplements) one tablet PO in AM, Zinc 50 mg PO QD, and Airborne Vitamin C one gummy QD. The PCG was asked as to how long the patient had been on these medications. The PCG and patient's family member stated it was long time ago. However, these medications were not listed on the Medication Profile. The SN did not update the Medication Profile to include these medications. b. Further review of the SN note dated 11/15 and 11/20/21, showed the SN performed wound care to the patient's right great toenail. The wound was cleansed with NSS (normal saline solution), patted dry, applied triple antibiotic ointment, and covered with a band aid. However, review of the Medication Profile failed to show documented evidenced the SN updated the Medication Profile to include triple antibiotic ointment for the treatment of the right great toenail wound. On 12/15/21 at 1358 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was informed and acknowledged the findings. 2. Review of Patient 2's closed clinical record was initiated on 12/7/21. The clinical record showed the SOC was 6/18/21. The patient was certified for home health services during the certification period from 6/18/21 to 8/16/21. The POC, for the certification period from 6/18/21 to 8/16/21, cited SN visits 1W1, 2W2, and 1W6 to assess the body systems to including the medication regimen. The POC included wound care assessment and treatment for the left buttock Stage 2 pressure injury. The wound treatment included Calazime ointment (for wound management). The Medication Profile showed the patient's medications included carvedilol (antihypertension) 12.5 mg one tablet PO BID, atorvastatin 80 mg one tablet PO QD, Aspirin (non-steroidal anti-inflammatory drug) 81 mg one tablet PO QD, Levemir ( antidiabetic) 20 units subcutaneous BID, Trulicity (antidiabetic) 0.3 mg subcutaneous once weekly, Excedrin ES (to treat migraine headache) 500 mg one tablet PO Q six hours PRN, Miralax (laxative) 17 gm per 4 ounces PO QD, Dulcolax (laxative) 10 mg one suppository per rectum PRN if no bowel movement for 3 days, and Fleet enema (laxative) one per rectum PRN if Dulcolax ineffective. However, review of the Medication Profile failed to show the SN had updated the medication profile to include Calazime ointment for the treatment of the left buttock Stage 2 pressure injury. On 12/15/21 at 1436 hours, an interview with concurrent closed clinical record review was conducted with LVN 2. LVN 2 was informed and acknowledged the findings. 3. Review of Patient's 8 clinical record was initiated on 12/10/21. The clinical record showed the SOC was 4/20/21. The patient was certified for home health services during the certification periods from 4/20/21 to 6/18/2, 6/19/21 to 8/17/21, 8/18/21 to 10/16/21, and 10/17/21 to 12/15/21. The POC, for the certification period from 8/18/21 to 10/16/21, cited SN visits 2W2 and 1W7 to assess all the body system including medication regimen. The POC included wound care assessment and treatment for the abrasion on the left ear. The wound treatment included triple antibiotic ointment. Review of the Medication Profile showed the patient's medications included Ceftriaxone (antibiotic) 1 gm via IV QD for seven days, Bactrim (antibiotic) 400-80 mg one tablet PO BID for seven days, Levaquin (antibiotic) 250 mg one tablet PO QD for seven days, atorvastatin 20 mg one tablet PO QD, hydralazine (antihypertension) 50 mg one tablet PO TID, docusate sodium (laxative) 100 mg one capsule PO BID, pregabalin (nerve pain) 100 mg one capsule PO BID, famotidine (stomach, duodenal ulcers) 20 mg one tablet PO QHS, amlodipine (antihypertension) 5 mg one tablet QD, isosorbide mononitrate (antiangina) 120 mg PO QD, furosemide (diuretic) 40 mg one tablet QD, clopidogrel (antiplatelet) 75 mg one tablet PO QD, icosapent ethyl (antilipidemic) 1 gm two capsules PO BID, hydrocodone- acetaminophen (opioid pain medication) 10-325 mg one tablet PO Q 4 hrs, paroxetine (antidepressant) 10 mg one tablet PO QD, tamsulosin hydrochloride (to treat enlarge prostate) 0.4 mg one capsule PO QD, Clobetasol propionate (topical steroid) 0.05% foam BID, Desoximetasone (skin discomfort) 0.05% topical ointment BID, metoprolol ( beta blocker) 50 mg one tablet PO BID, glipizide (antidiabetic) 10 mg one tablet PO QD, multivitamin (supplement) one tablet PO QD, vitamin D3 (supplement) 1000 mg one tablet PO QD, Banophen (antihistamine) 25 mg one capsule PO Q 6 hrs, Bisacodyl (laxative) 5 mg one tablet PO QD PRN, nitroglycerine (chest pain) 0.4 mg sublingual every 5 minutes PRN for three doses, ondansetron (antiemetic) 4 mg one tablet PO Q eight hours PRN, and Tresiba (insulin) injectable 40 units subcutaneous QD. However, review of the Medication Profile failed to show the SN had updated the medication profile to include triple antibiotic ointment for the treatment of the left ear wound. On 12/15/21 at 1319 hours, an interview with concurrent closed clinical record review was conducted with LVN 2. LVN 2 was informed and acknowledged the findings. 4. Review of Patient 10's clinical record was initiated on 12/10/21. The clinical record showed the SOC was 3/22/20. The patient was certified for home health services during the certification periods from 9/13/21 to 11/11/21 and 11/12/21 to 1/10/22. The POC, for the certification period from 9/13/21 to 11/11/21 and 11/12/21 to 1/10/22, cited for SN visits 1W9 for all the body system assessments. Review of the Wound Care Visit progress notes dated 11/26/21, showed the wound care order for the treatment of the G-tube stoma irritation. The treatment included an application of silver nitrate to the wound bed, cover with a gauze, and secure with a tape. The Medication Profile showed the patient's medications included levofloxacin (antibiotic) 10 ml via G-tube QD for ten days, albuterol sulfate (bronchodilator) 3 mg-2.5 mg albuterol-ipratropium bromide 0.5 mg inhalant solution via HHN two times a week for one week, phenytoin (anticonvulsant) 125 mg per 5 ml BID via G-tube, Zovirax (antiviral) 200 mg one capsule BID via G-tube, potassium chloride (potassium supplement) 20 meq ER one tablet BID via G-tube, Wellbutrin (antidepressant) 200 mg one tablet QD via G-tube, Proscar (to treat enlarge prostate) 5 mg one tablet QD via G-tube, levetiracetam (antiseizure) 100 mg/ml 15 ml BID via G-tube, vitamin B12 (supplement) 1000 mcg via IM injection one a month, Aricept (dementia) 5 mg one tablet Q HS via G-tube, gabapentin (anticonvulsant) 100 mg one tablet QD via G-tube, Lipitor (anticholesterol) 40 mg one tablet Q HS via G-tube, Prednisolone acetate ophthalmic suspension (eye inflammation) one drop in right eye QD, Systane (to treat dry eyes) one drop in left eye QD, Glytrol (nutritional supplement) two cans via G-tube TID bolus and omeprazole (stomach acid) 40 mg one capsule Q HS via G-tube. However, review of the Medication Profile failed to show the SN had updated the medication profile to include silver nitrate for the treatment of the G-tube stoma irritation. On 12/15/21 at 1225 hours, an interview was conducted with LVN 2. LVN 2 was asked if the silver nitrate was included in the medication profile. LVN 2 stated the medication profile was not updated and should have been updated. LVN 2 was informed and acknowledged the findings.

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on clinical record review and interview, the agency failed to ensure the update comprehensive assessment was completed within 48 hours of the patient's return to home from the hospital for one of 10 sampled patients (Patient 4), creating the risk of not providing the necessary care and services timely to meet the care needs for these patients. Findings: Review of Patient 4's clinical record was initiated on 12/7/21. The clinical record showed the SOC was 10/10/21. The patient was certified for home health services during the certification period from 10/10/21 to 12/8/21. The resumption of care comprehensive assessment dated 11/10/21, showed no documented evidence the patient's hand grips were assessed. In addition, the assessment showed the patient had a peripheral IV line. However, there was no documented evidence of the location and the status of the IV site. On 10/15/21 at 1209 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on clinical record review and interview, the agency failed to ensure the comprehensive assessment was completed at discharge for one of 10 sampled patients (Patient 3), creating the risk of not updating the patient's status for this patient. Review of Patient 3's closed clinical record was initiated on 12/9/21. The closed clinical record showed the SOC was 10/1/21. The patient was certified for home health services during the certification period from 10/1/21 to 11/29/21. The discharge comprehensive assessment dated 11/24/21, showed no documented evidence the patient's psychosocial status was completed. On 12/15/21 at 1315 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on interview and clinical record review, the agency failed to ensure the patients received care and services as per the written POCs for six of 10 sampled patients (Patients 2, 4, 5, 7, 8, and 10), creating the risk of not providing appropriate, consistent, and quality of care to these patients. 5. Review of Patient 4's clinical record was initiated on 12/7/21. The clinical record showed the SOC was 10/10/21. The patient was certified for home health services during the certification period from 10/10/21 to 12/8/21. The physician's order dated 11/10/21, showed to resume home health services. The order showed SN visits 3W4 and 2W1 to perform wound treatment as follows: cleanse Stage 2 left buttock pressure injury with NS, pat dry, then apply Duoderm (wound dressing) three time a week for two weeks then reassess. The physician's order dated 11/19/21, showed refer the patient to the Professional Wound Specialist for pressure injury evaluation and skin assessment. * However, there was no documented evidence a referral to the Professional Wound Specialist was made. On 10/15/21 at 1209 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 6. Review of Patient 7's clinical record was initiated on 12/9/21. The clinical record showed the SOC was 10/22/21. The patient was certified for home health services during the certification period from 10/22/21 to 12/20/21. The SN note dated 11/12/21, showed the left buttock excoriation was identified. The SN notes dated 11/12 and 11/15/21, showed the left buttock excoriation was cleansed with NS, patted dry, and applied with Calmoseptine cream (moisture barrier). The Case Manager was updated. * However, there was no documented evidence a POC or physician's order to cleanse the left buttock excoriation with NS, pat dry, and apply Calmoseptine cream until 11/22/21, five days after the left buttock excoriation was identified. The physician's order dated 11/17/21, showed a report was received from LVN 1 that the patient had excoriation to the left buttocks. The status report was given to the physician. The order included to cleanse the left buttock excoriation with NS, pat dry, apply Calmoseptine cream and leave open to air daily for two weeks; and the PCG may perform treatment on the non SN visit days. On 10/15/21 at 1209 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 1. Review of Patient 5's clinical record was initiated on 12/8/21. The clinical record showed the SOC was 11/12/21. The patient was certified for home health services during the certification period from 11/12/21 to 1/10/22. a. The POC, for the certification period from 11/12/21 to 1/10/21, cited SN visits 1W1, 2W1, and 1W7 to assess all the body systems. The POC also showed a referral to a podiatrist. Review of the Initial Case Conference note dated 11/12/21, showed a wound care order for the right great toe and a referral to a podiatrist. Further review of the Physicians' Admission orders dated 11/12/21, showed a referral order for a podiatrist. However, review of the clinical record failed to show a documented evidenced the SN had coordinated the podiatry referral as cited in the POC. On 12/15/21 at 1338 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was asked if the podiatry referral order was followed. LVN 2 stated no, nothing was uploaded; had no documentation to provide; and verified not following the POC. b. Review of the POC, for the certification period from 11/12/21 to 1/10/21, showed an order for the PT evaluation and visit for the week of 11/14/21. Review of the Communication Note dated 11/16/21, showed the patient's family member requested to reschedule the PT evaluation for the following week. However, review of the clinical record failed to show documented evidenced the MD was notified of the rescheduled visit. On 12/15/21 at 1348 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was asked if the physician was notified of the rescheduled visit for the PT evaluation. LVN 2 stated it was written in the communication note, but the physician was not notified. LVN 2 was informed and acknowledged the findings. 2. Review of Patient 2's closed clinical record was initiated on 12/7/21. The clinical record showed the SOC was 6/18/21. The patient was certified for home health services during the certification period from 6/18/21 to 8/16/21. The POC, for the certification period from 6/18/21 to 8/16/21, cited SN visits 1W1, 2W2, and 1W6 to assess all body systems. The POC also showed a referral to a podiatrist. Review of the Physicians' Admission Order dated 6/18/21, showed an order for a podiatry consult for a diabetic toenails. Review of the Initial Case Conference note dated 6/18/21, showed a referral needed for a podiatrist. However, review of the closed clinical record failed to show documented evidenced the SN had coordinated for the podiatry referral as cited in the POC. On 12/15/21 at 1431 hours, an interview with concurrent closed clinical record review was conducted with LVN 2. LVN 2 was asked if the patient was referred to the podiatrist as written on the POC. LVN 2 stated there was no documentation available and verified the POC was not followed. 3. Review of Patient's 8 clinical record was initiated on 12/10/21. The clinical record showed the SOC was 4/20/21. The patient was certified for home health services during the certification periods from 4/20/21 to 6/18/2, 6/19/21 to 8/17/21, 8/18/21 to 10/16/21, and 10/17/21 to 12/15/21. Review of the POC, for the certification period from 8/18/21 to 10/16/21, showed Patient 8's other pertinent diagnoses includes hypothyroidism, unspecified. Further review of the POC showed Patient 8's list of medication included Levothyroxine (to treat hypothyroidism) 200 mcg one tablet PO QD. Review of the SN notes dated 8/23, 8/25, 8/31, 9/10, 9/14, 9/17, 9/21, 9/24, 9/29, 10/1, 10/2, 10/3, 10/4, 10/5, 10/6, and 10/7/21, showed the SN had performed body system assessment including endocrine system. However, the SN notes failed to include hypothyroidism as part of the endocrine assessment. On 12/15/21 at 1325 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was asked if the hypothyroidism should be included as part of the endocrine assessment. LVN 2 stated it should have been assessed and it was not documented on the section for "others" as part of the endocrine system. LVN 2 was informed and acknowledged the findings. 4. Review of Patient 10's clinical record was initiated on 12/10/21. The clinical record showed the SOC was 3/22/20. The patient was certified for home health services during the certification periods from 9/13/21 to 11/11/21, and 11/12/21 to 1/10/22. Review of the POC, for the certification period from 9/13/21 to 11/11/21 and 11/12/21 to 1/10/22, cited for SN visits 1W9 for all body system assessments. The POC also cited CHHA visits 1W9 to assist with ADL care, personal care and hygiene, skin/ foot care, grooming and bathing, ambulation exercise, and light housekeeping. Review of the CHHA visit notes showed the CHHA had a missed visit on 9/29/21, during Week 3 (9/26/21 to 10/2/21. However, there was no documented evidence the staff had coordinated to reschedule a visit for Week 3. On 12/15/21 at 1233 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was asked if there was a rescheduled visit for the missed visit. LVN 2 stated there was nothing documented and they should have rescheduled a visit. LVN 2 was informed and acknowledged the findings.

Review and revision of the plan of care CFR(s): 484.60(c) Standard: Review and revision of the plan of care. This STANDARD is not met as evidenced by: Based on clinical record review and interview, the agency failed to revise and update the POC for one of 10 sampled patients (Patient 4), creating the risk for not providing necessary care and services to meet the care needs for these patients. Findings: Review of Patient 4's clinical record was initiated on 12/7/21. The clinical record showed the SOC was 10/10/21. The patient was certified for home health services during the certification period from 10/10/21 to 12/8/21. Review of the resumption of care comprehensive assessment showed dated 11/1/0/21, showed the patient had an IV peripheral line. The physician's order dated 11/10/21, showed Meropenem (antibiotic) 500 mg/100 ml NS infuse over 30 minutes IV once QD for 10 days. The order showed the dialysis nurse to give the dose during the dialysis days. However, there was no documented evidence of the POC to start and care of the patient's IV peripheral line for the use of IV antibiotic. On 12/15/21 at 1209 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on interview and clinical record review, the agency failed to communicate with the physician to meet the patients' care needs for two of 10 sampled patients (Patients 4 and 7), creating the risk of not providing the necessary care and services to these patients. 1. Review of Patient 4's clinical record was initiated on 12/7/21. The clinical record showed the SOC was 10/10/21. The patient was certified for home health services during the certification period from 10/10/21 to 12/8/21. The physician's order dated 11/10/21, showed to resume the home health services. The order showed SN visits 3W4 and 2W1 and to administer Meropenem 500 mg /100 NS over 30 minutes IV QD for 10 days. The order also showed the dialysis nurse to give the does during dialysis days. The Communication Note dated 12/3/21, showed a note addressing the patient's physician. Documentation showed a report was received from the SN that the patient was complaining of a headache, diarrhea six times last night and feeling dizzy. Documentation showed the PCG gave loperamide (antidiarrhea) last night (12/2/21). The patient refused to go to dialysis today (12/3/21) and to please advise. The SN note dated 12/3/21, showed the patient complained of headache with a pain level of 9 (on a 0-10 pain scale with 0=no pain and 10=worst pain). The patient had history of migraine. The patient had diarrhea six times and did not sleep well last night. The note showed the patient took loperamide 2 mg PO between 0500 hours to 0600 hours. The note showed to notify the physician if needed to repeat stool sample, urinalysis, and if the IV line in the right forearm be discontinued. The SN note also included the same information as showed in the Communication Note dated 12/3/21. * However, there was no documented evidence the HHA had communicated or followed up with the physician regarding the repeat stool sample, urinalysis, and if the IV line in the right forearm would be discontinued. On 12/15/21 at 1209 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 2. Review of Patient 7's clinical record was initiated on 12/9/21. The clinical record showed the SOC was 10/22/21. The patient was certified for home health services during the certification period from 10/22/21 to 12/20/21. The SN note dated 10/26/21, showed the patient had rales on bilateral lungs. The Case Manager was made aware. The physician's order dated 10/26/21, showed to send to the mobile x-ray to rule out pneumonia. The chest x-ray result dated 10/27/21, showed the right sided interstitial infiltrate. * However, there was no documented evidence the physician was informed of the above chest x-ray result. On 12/15/21 at 1209 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS 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 observation, clinical record review, and interview, the agency failed to ensure the effective coordination for three of 10 sampled patients (Patients 1, 5, and 8), creating the risk of not providing necessary care and services to these patients. 3. Review of Patient 1's clinical record was initiated on 12/9/21. The clinical record showed the SOC was 2/22/21. The patient was certified for home health services during the certification period from 2/22/21 to 4/22/21. The POC, for the certification period from 2/22/21 to 4/22/21, showed Patient 1's diagnoses including pressure injury of the right buttock- Stage 2, hemiplegia and hemiparesis following cerebral infarction affecting left non- dominant side, and gout. The POC cited PT evaluation for physical, functional level, educate on safety awareness, perform therapeutic exercises, muscle re-education, and to establish home exercise program. Review of Patient 1's Physician's Order dated 2/23/21, showed PT visits 2W3 and 1W1, to provide evaluation, gait training, transfer training, functional training, caregiver/ family training, balance exercise, modalities and pain management, and therapeutic exercises. Review of Patient 1's PT Evaluation dated 2/23/21, showed PT visits 2W3 and 1W1, effective on 2/23/21. Review of Patient 1's Physician's Order dated 2/28/21, showed to hold PT visit and resume during week of 3/7/21, with frequency of 2W3. Review of Patient 1's Physician's Order dated 3/17/21, showed hold PT per the patient's request. Review of Patient 1's PT and PTA Visit notes showed the PT visits conducted on 2/23, 3/9, 3/11, 3/15, and 3/17/21. Review of Patient 1's PT Re- Evaluation dated 3/17/21, showed Patient 1 made good progress with therapy and to resume gait training as tolerated. Further review of the re-evaluation showed PT visits 2W1, effective on 3/21/21. Further review of Patient 1's clinical record failed to show documentation of the PT visits after 3/17/21. Review of Patient 1's Physician Order dated 4/21/21, showed to discharge the patient from home health services with instructions to follow up with the PCP. On 12/15/21 at 1202 hours, an interview and concurrent medical record review was conducted with LVN 3. LVN 3 was informed and acknowledged the above findings. The agency's P&P titled Care Coordination revised April 2014 showed to ensure the coordination of services for each patient and to minimize the potential missed, conflicting, or duplicate services. Timely and ongoing communication is the responsibility of each team member, will be appropriate to the to the needs and abilities of the patient, and will be relevant to the care provided. Written evidence of the care coordination will be recorded during the case conference and repeated in the skilled nursing visit reports in the patient's clinical records. 1. Review of Patient 5's clinical record was initiated on 12/8/21. The clinical record showed the SOC was 11/12/21. The patient was certified for home health services during the certification period from 11/12/21 to 1/10/22. The POC, for the certification period from 11/12/21 to 1/10/21, showed Patient 5's principal diagnosis was Polyosteoarthritis, unspecified. The other pertinent diagnoses includes pain on the right and left hips. The POC cited PT evaluation for physical, functional level, educate on safety awareness, perform therapeutic exercises, muscle re-education and to establish home exercise program. The POC also cited PT to focus on the assessment of the level and location of pain. Review of the PT visit note dated 12/1/21, showed the PT had performed the pain assessment. The patient was assessed to have pain to the right groin. The pain prior to the therapy was assessed to be at level 2 and post therapy was a level 3. The pain was increased by movement and relieved by rest, and interfered with transfers and bed mobility. Further review of the PT visit note showed the patient complains of pain along the right hip/groin and knee. The pain occurred during the weight bearing movement and was minimal at rest. Review of the PT notes dated 12/3/21, showed the PT performed pain assessment. The patient was assessed to have pain to the right groin. The pain prior to the therapy was assessed to be at level 2 and post therapy was at level 4. The pain was increased by movement and relieved by rest, and interfered with transfers and bed mobility. On 12/8/21 at 1100 hours, a joint home visit was conducted with PTA 1. PTA 1 assisted the patient to perform the exercises as ordered. The patient was able to follow the instructions and performed the exercises. However, the patient constantly stating the "right leg is hurting" during the exercises. On 12/8/21 at 1254 hours, an interview with concurrent clinical record review was conducted with PTA 1. PTA 1 was asked about the patient's level of pain. The PTA stated he did not ask for the pain level and he already knew the patient's pain level which was same as before, it is difficult to gauge. The PTA stated he used Wong Baker to assess the level of pain. PTA 1 was asked if he needed to notify the nurse about the patient's pain. He stated no, only to notify the nurse when the patient experienced severe pain and needed to take the pain medication to relieve the pain. The patient was taking Tylenol prior to the PT visit. PTA 1 was asked if he needed to notify the nurse if the patient was taking Tylenol. He stated no. In addition, review of the Initial Comprehensive Assessment dated 11/12/21, showed the RN performed pain assessment. Patient 5's current pain level was 3 and pain was assessed to be worst at a level of 6. The pain was located on bilateral hip with intermittent in onset and described as aching type. However, review of the Medical Profile failed to show documented evidence of the medication to manage the pain on the right groin. Further review of the clinical record failed to show the coordination between the HHA staff and physician for an order of pain medication. On 12/8/21 at 1337 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was asked if there was a medication to address the patient's pain. LVN 2 stated no pain medication was ordered and they should have ordered. PTA 1 should have reported to the nurse or HHA. We should have notified the physician to obtain an order for pain medication. LVN 2 was informed and acknowledged the findings. 2. Review of Patient's 8 clinical record was initiated on 12/10/21. The clinical record showed the SOC was 4/20/21. The patient was certified for home health services during the certification periods from 4/20/21 to 6/18/2, 6/19/21 to 8/17/21, 8/18/21 to 10/16/21, and 10/17/21 to 12/15/21. a. Review of the Others - MSW order/New wound Order dated 9/14/21, showed an order for MSW evaluation/visit 1 to 3 visits within the certification to assist the patient to obtain necessary community resources to enable to remain at home and provide brief therapy regarding improved management/adjusted to illness and facilitate coping with increased function limitations. However, review of the clinical record failed to show documented evidence of the coordination for the MSW visit as ordered. b. Review of the Others - Podiatry Order dated 10/5/21, showed an order for a referral to a podiatrist for a home visit evaluation. However, review of the clinical record failed to show documented evidenced of the coordination for the podiatrist as ordered. On 12/15/21 at 1328 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was asked if there was a coordination for MSW visits. The LVN stated there was nothing documented. LVN 2 was further asked regarding the order for a podiatry. LVN 2 stated nothing was documented. She 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 clinical record review, the agency failed to provide the written instructions outlining the SN visit schedule for three of 10 sampled patients (Patients 4, 5, and 7), creating the risk of not providing the necessary information to these patients. 2. Review of Patient 4's clinical record was initiated on 12/7/21. The clinical record showed the SOC was 10/10/21. The patient was certified for home health services during the certification period from 10/10/21 to 12/8/21. The physician's order dated 11/10/21, showed SN visits 3W4 and 2W1 for the assessment of the patient's overall condition. A joint home visit with RN 1 was conducted on 12/8/21 at 0800 hours, to Patient 4's home. RN 1 was asked for the written instructions outlining the SN visit schedule. RN 1 stated there was no written instruction outlining the SN visit schedule provided to the patient. The PCG was interviewed on how he would knew the SN visit schedule. The PCG stated the SN would call ahead of time. Review of the patient's home folder provided by the HHA showed no documented evidence of the written instructions outlining the SN visit schedule. On 12/15/21 at 1209 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 3. Review of Patient 7's clinical record was initiated on 12/9/21. The clinical record showed the SOC was 10/22/21. The patient was certified for home health services during the certification period from 10/22/21 to 12/20/21. A joint home visit with LVN 1 was conducted on 12/8/21 at 1300 hours, to Patient 7's home. LVN 1 was asked for the written instructions outlining the SN visit schedule. LVN 1 stated there was no written instruction outlining the SN visit schedule provided to the patient. LVN 1 stated he would call a day ahead of the visit. Review of the patient's home folder provided by the HHA showed no documented evidence of the written instructions outlining the SN visit schedule. On 12/15/21 at 1230 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 1. Review of Patient 5's clinical record was initiated on 12/8/21. The clinical record showed the SOC was 11/12/21. The patient was certified for home health services during the certification period from 11/12/21 to 1/10/22. The POC, for the certification period from 11/12/21 to 1/10/21, cited SN visits 1W1, 2W1, and 1W7 to assess all the body systems. The POC also showed a PT evaluation/visit during the week of 11/14/21. Review of the PT evaluation note dated 11/22/21, showed PT visit frequency as 1W1 and 2W3. A joint home visit with PTA 1 was conducted on 12/8/21at 1100 hours, to Patient 5's home. PTA 1 was asked for the written instructions outlining the visit schedule. PTA 1 opened the admission packet and stated he did not use a visit calendar. PTA 1 stated he called the patient's family member on the day of the visit and the patient's family member would notify the PCG. The PCG was asked about the schedule of the visits. The PCG stated they would call the patient's family member and the family member would be the one to inform her of the SN visit. However, review of the patient's home folder provided by the HHA showed no documented evidence of the written instructions outlining the SN and the PT visit schedule. On 12/15/21 at 1351 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was asked if they provided a written visit schedule to the patient. LVN 2 stated yes, the visit schedule should be provided by the RN who did the SOC OASIS assessment. LVN 2 was informed and acknowledged the findings.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on observation, interview, and clinical record review, the agency failed to provide the name and information of the clinical manager for two of 10 sampled patients (Patients 5 and 7), creating the risk of not providing the necessary information to these patients. 2. Review of Patient 7's clinical record was initiated on 12/9/21. The clinical record showed the SOC was 10/22/21. The patient was certified for home health services during the certification period from 10/22/21 to 12/20/21. A joint home visit with LVN 1 was conducted on 12/8/21 at 1300 hours, to Patient 7's home. Review of the patient's home folder provided by the HHA showed no documented evidence of the written instructions outlining the name and contact information of the HHA's clinical manager. On 12/15/21 at 1230 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the finding. 1. Review of Patient 5's clinical record was initiated on 12/8/21. The clinical record showed the SOC was 11/12/21. The patient was certified for home health services during the certification period from 11/12/21 to 1/10/22. The POC, for the certification period from 11/12/21 to 1/10/21, cited SN visits 1W1, 2W1, and 1W7 to assess body systems. The POC also showed a PT evaluation/visit during the week of 11/14/21. Review of the PT evaluation noted dated 11/22/21, showed PT visit frequency as 1w1 and 2w3. A joint home visit with PTA 1 was conducted on 12/8/21at 1100 hours, to Patient 5's home. The PCG was asked as to how to contact the agency if there was any concern. The PCG stated she did not contact the agency but called the patient's family member instead. However, review of the patient's home folder provided by the HHA showed the contact information of the agency's President/CEO instead of the clinical manager. On 12/15/21 at 1351 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 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 clinical record review, the agency failed to ensure infection control practices were implemented for one of 10 sampled patients (Patient 7). This posed the risk for the spread of infectious organisms. According to the CDC, hand hygiene means cleaning your hands by using either handwashing (washing hands with soap and water), antiseptic hand wash, antiseptic hand rub (i.e. alcohol-based hand sanitizer including foam or gel), or surgical hand antisepsis. Cleaning your hands reduces: the spread of potentially deadly germs to patients and the risk of healthcare provider colonization or infection caused by germs acquired from the patient. Following are the clinical indications for hand hygiene: Use an alcohol-based hand sanitizer immediately before touching a patient; before performing an aseptic task ( for example, 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; and immediately after glove removal. Wash with soap and water when hands are visibly soiled; caring for a person with known or suspected infectious diarrhea; and after known or suspected exposure to spores (for example B. anthracis, C difficile outbreaks) Review of Patient 7's clinical record was initiated on 12/9/21. The clinical record showed the SOC was 10/22/21. The patient was certified for home health services during the certification period from 10/22/21 to 12/20/21. A joint home visit with LVN 1 was conducted on 12/8/21 at 1300 hours, to Patient 7's home. LVN 1 was observed performing wound care to the patient's left buttock excoriation. LVN 1 donned gloves, cleansed the left buttock excoriation with a wound cleanser and disposable wash cloths, then doffed the gloves. LVN took out the cellular phone from his pocket and photographed the patient's left buttock excoriation. However, LVN 1 failed to perform hand hygiene after doffing the gloves. On 12/15/21 at 1230 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the finding.

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 which included surveillance, identification, prevention, control, and investigation of infections, creating the risk of spread of infections. The agency's P&P titled Evaluating and Maintaining Records of Infections Among Patients dated 04/23 showed the patient report form is completed when any of the following occur: a new, actual, or suspected infection is observed by home care personnel, a culture is ordered and performed and the results are positive, a new antibiotic is ordered, a patient is admitted to a hospital due to an actual or suspected infection, the patient dies due to an actual or suspected infection, a reportable communicable infection is identified, patient has a temperature greater that 101 degrees Fahrenheit. The Case Manager or the nurse caring for the patient in his/her absence should complete the Infection Identification Patient Report within 24 hours of discovering the infection. Each section of the report should be completed in its entirety. After completion the original form will be sent to the Performance Improvement Coordinator summarizes, trends, and analyzes the reports. The break down and summary may include, but not limited to: number of types of infection, diagnoses, age/sex of patients, family/caregiver, pathogens, and orders/medication. The Performance Improvement Coordinator, in conjunction with the Clinical Coordinator, will investigate possible causal factors and recommend appropriate action to contain the transmission of infection. A report on infections will be given to each Performance Improvement Committee meeting. A summary will be provided to the Professional Advisory Committee. Information from the summary, analysis, and discussion will be used to improve patient care. Review of the Infection Control Report for 2021 showed the following information: - For January 2021, there were a total of five infections. One of the infection case was present on the SOC and four cases were developed during the certification period. The sites of infection were classified as follows: two for genitourinary, two for integumentary, one for "other." There was none for respiratory, gastrointestinal, and "prophylaxis." - For February 2021, there were a total of eight infections. Three of the infection cases were present on the SOC and five cases were developed during the certification period. The sites of infection included two for genitourinary, three for integumentary, two for respiratory, and one for gastrointestinal. - For March 2021, there were a total of 13 infections. Three of the infection cases were present on the SOC and 10 cases were developed during the certification period. The sites of infection included two for genitourinary, seven for integumentary, three for respiratory, and one for "other." - For April 2021, there were a total of 10 infections. Three of the infection cases were present on the SOC and seven cases were developed during the certification period. The sites of infection were classified as follows: one for genitourinary, five for integumentary, three for "other," and one for for respiratory. - For May 2021, there were a total of 10 infections. Five of the infection cases were present on the SOC and five cases were developed during the certification period. The sites of infection included four for genitourinary, two for integumentary, three for "other," and one for respiratory. - For June 2021, there were a total of 15 infections. Seven of the infection cases were present on the SOC and eight cases were developed during the certification period. The site of infection were classified as follows: five for genitourinary, three for integumentary, five for "other," one for respiratory, and one for gastrointestinal. - For July 2021, there were a total of 16 infections. Five of the infection cases were present on the SOC and 11 cases were developed during the certification period. The sites of infection were classified as follows: six for genitourinary, seven for integumentary, two for "other," and one for respiratory. - For August 2021, there were a total of 23 infections. Six of the infection cases were present on the SOC and 17 cases were developed during the certification period. The sites of infection were classified as follows: nine for genitourinary, four for integumentary, eight for "other," one for respiratory, and one for gastrointestinal. - For September 2021, there were a total of 30 infections. Ten of the infection cases were present on the SOC and 20 cases were developed during the certification period. The sites of infection were classified as follows: nine for genitourinary, 13 for integumentary, eight for "other." On 12/15/21 at 1405 hours, a concurrent review and document review was conducted with the DPCS. The monthly Infection Control Report showed inaccurate information related to the number of the site infection. For example: - Review of each individual Infection Control Report for July 2021 was conducted and tallied according to the site infection. The DPCS stated for July 2021, there were a total of 16 infections. She stated nine of the infections were identified as integumentary instead of seven as listed in the July 2021 Infection Control Report. The DPCS stated there were no infections under the "Other," instead of two cases listed in the July 2021 Infection Control Report. On 12/15/21 at 1415 hours, the DPCS stated the Care Coordinator obtained the data from the patient's clinical records. She stated the Care Coordinator would document on the patient's Infection Control Report. The DPCS stated the patient who was on antibiotic and had COVID-19 infection even without an antibiotic would be included in the individual report. She stated the DPCS would collect the data and total the number of infections for the month; infections which were present at their SOC and within their certification period; and the site of the infection. She stated the DPCS would give the monthly Infection Control Report to the QAPI committee for review. The DPCS stated the QAPI meetings were held monthly and changed to quarterly on September 2021. Further review of the agency's documents showed no documented evidence the agency had analyzed the data, investigated for possible causes of infections, and implemented specific actions to minimize infections. In addition, the monthly Infection Report did not specify what site of infection for "Other." On 12/15/21 at 1415 hours, the 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 clinical record review, the agency failed to ensure the skilled professionals provided care and services in accordance with the POC for two of 10 sampled patients (Patients 4 and 9). This posed the risk of not providing appropriate, consistent, and quality care to these patients. 2. Review of Patient 9's clinical record was initiated on 12/9/21. The clinical record showed the SOC was 11/2/21. The patient was certified for home health services during the certification period from 11/2/21 to 12/31/21. The POC, for the certification period from 11/2/21 to 12/31/21, cited SN visits 2W9 for the skilled assessment of all body system. The POC also showed SN to perform wound assessment and treatment for Stage 3 pressure injuries on the right and left buttocks. Review of the Wound Care Worksheet dated 11/26/21, showed the SN had performed wound assessment and treatment for the Stage 3 right buttock pressure injury. However, the assessment for wound status of Stage 3 right buttock pressure injury was blank. On 12/15/21 at 1423 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was asked about the assessment of the wound status for Stage 3 right buttock pressure injury. LVN 2 stated the wound status was not assessed. LVN 2 was informed and acknowledged the finding. 1. Review of Patient 4's clinical record was initiated on 12/7/21. The clinical record showed the SOC was 10/10/21. The patient was certified for home health services during the certification period from 10/10/21 to 12/8/21. The POC, for the certification period from 9/10/21 to 12/8/21, cited SN visits 3W4. The POC also showed SN to report to MD for any sign/symptoms of infection, if SBP less than 90 mmHg or greater than 160 mmHg, and if DBP less than 50 mmHg or heart rate greater than 110 beats per minute. The physician's order dated 11/2/21, showed to hold home health services. The order showed may resume services when the patient discharged from the hospital. The physician's order dated 11/10/21, showed to resume home health services. The order showed SN visits 3W4 and 2W1. The SN visit dated 11/26/21, showed the patient's BP was 166/80 mmHg. The SN visit dated 11/29/21, showed the patient's BP was 178/80 mmHg. The SN visit dated 12/6/21, showed the patient's BP was 168/72 mmHg. However, there was no documented evidence the patient's BP was rechecked or the physician was notified as per the POC. On 12/15/21 at 1209 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged 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 clinical record review, the agency failed to ensure the agency's skilled professionals prepared accurate clinical notes for seven of 10 sampled patients (Patients 3, 4, 6, 7, 8, 9, and 10), creating the increased risk of substandard healthcare outcomes to these patients. 5. Review of Patient 9's clinical record was initiated on 12/9/21. The clinical record showed the SOC was 11/2/21. The patient was certified for home health services during the certification period from 11/2/21 to 12/31/21. The POC, for the certification period from 11/2/21 to 12/31/21, cited SN visits 2W9 for the skilled assessment of all body system. The POC also showed the SN to perform wound assessment and treatment for the Stage 3 pressure injury to the right and left buttocks. Review of the Wound Care Worksheets dated 11/2, 11/12, and 11/19/21, showed the SN had performed wound assessment and treatment for the Stage 3 right buttock pressure injury. However, the Stage 3 right buttock pressure injury wound assessment showed a number 3. On 12/15/21 at 1424 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was asked as to the meaning of number 3. LVN 2 stated it was an error. LVN 2 was informed and acknowledged the findings. 6. Review of Patient 10's clinical record was initiated on 12/10/21. The clinical record showed the SOC was 3/22/20. The patient was certified for home health services during the certification periods from 9/13/21 to 11/11/21 and 11/12/21 to 1/10/22. The POC, for the certification period from 9/13/21 to 11/11/21 and 11/12/21 to 1/10/22, cited for SN visits 1W9 for all body system assessments. The POC also showed CHHA visits 1W9 to assist with the ADL care, personal care and hygiene, skin/foot care, grooming and bathing, ambulation exercise, and light housekeeping. Review of the CHHA Supervisory Visit note dated 12/5/21, showed the RN performed a supervisory visit for the patient's CHHA. However, review of the CHHA Supervisory Visit note showed the RN performed the supervisory visit dated 12/6/21, which was inconsistent with the CHHA Supervisory Visit note. On 12/10/21 at 1459 hours, an interview with concurrent clinical record review was conducted with the DPCS. The DPCS was asked as to when the actual visit date was. The DPCS stated the correct visit date was 12/6/21, instead on 12/5/ 21. The 12/6/21 visit was a telephone visit and not an actual joint visit. On 12/15/21 at 1202 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was informed and acknowledged the findings. 7. Review of Patient's 8 clinical record was initiated on 12/10/21. The clinical record showed the SOC was 4/20/21. The patient was certified for home health services during the certification periods from 4/20/21 to 6/18/2, 6/19/21 to 8/17/21, 8/18/21 to 10/16/21, and 10/17/21 to 12/15/21. The POC, for the certification period from 8/18/21 to 10/16/21, cited SN visits 2W2 and 1W7 to assess all body system including the medication regimen. The POC included wound care assessment and treatment for the abrasion on the left ear. The wound treatment included triple antibiotic ointment. Review of the SN notes dated 8/19 and 8/23/21, showed the narrative notes showing the SN had performed the wound treatment to the left ear. Further review of the SN assessment notes dated 8/19 and 8/23/21, showed the SN had placed a check mark referring to the wound sheet assessment and treatment . However, the wound sheet assessment and treatment was not completed. On 12/15/21 at 1316 hours, an interview with concurrent clinical record review was conducted with LVN 2. LVN 2 was informed and acknowledged the findings. 4. Review of Patient 6's clinical record was initiated on 12/8/21. The clinical record showed the SOC was 1/21/21. The patient was certified for home health services during the certification period from 11/15/21 to 1/13/21. The POC for this certification period showed the nutritional requirement was the no added salt, no concentrated sugars, and low cholesterol diet. Review of the Nursing Progress Notes dated 11/15, 11/22, and 11/29/21, showed Patient 6's diet was the low fat, no concentrated sweets, no added salt, and high protein diet, which was not consistent with the POC. On 12/15/21 at 1202 hours, an interview and concurrent clinical record review was conducted with LVN 3. LVN 3 was informed and acknowledged the findings. 1. Review of Patient 4's clinical record was initiated on 12/7/21. The clinical record showed the SOC was 10/10/21. The patient was certified for home health services during the certification period from 10/10/21 to 12/8/21. a. The POC, for the certification period from 10/10/21 to 12/8/21, showed the diet included no added salt, controlled carbohydrate, and no concentrated sweet diet. The SN notes dated 10/12, 10/14. 110/18, 10/20, 10/22, 10/25, 10/27, 10/29, and 11/1/21, showed the patient's diet was the controlled carbohydrate and renal diet, which was inconsistent with the POC. b. The resumption of care comprehensive assessment dated 11/10/21, showed the patient did not have a skin breakdown. However, the Wound Care Work Sheet dated 11/10/21, showed the patient had the Stage 2 left buttock pressure injury. On 12/15/21 at 1209 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 2. Review of Patient 7's clinical record was initiated on 12/9/21. The clinical record showed the SOC was 10/22/21. The patient was certified for home health services during the certification period from 10/22/21 to 12/20/21. The POC, for the certification period from 10/22/21 to 12/20/21, showed the diet was the ow salt, low fat, and low cholesterol diet. The SN notes dated 10/25, 10,27, 10/29, 11/1 11/3, 11/5, 11/8, 11/10,11/12, 11/15, 11/17, 11/19, 11/22, 11/24, 11/27, and 11/29/21, showed the patient's diet was a regular diet which was inconsistent with the POC. On 12/15/21 at 1230 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings. 3. Review of Patient 3's closed clinical record was initiated on 12/9/21. The closed clinical record showed the SOC was 10/1/21. The patient was certified for home health services during the certification period from 10/1/21 to 11/29/21. The POC, for the certification period from 10/1/21 to 11/29/21, showed the diet was the controlled carbohydrate, low salt, low fat, and low cholesterol diet. The SN notes dated 10/4, 10/6, 10/8, 10/16, 10/22, and 10/27/21, showed the patient's diet was the no added salt and "CCHO" diet which was inconsistent with the POC. On 12/15/21 at 1315 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech-language pathology services, a registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in §484.80(g), must make an onsite visit to the patient's home no less frequently than every 14 days. The home health aide does not have to be present during this visit. This ELEMENT is not met as evidenced by: Based on clinical record review and interview, the agency failed to ensure the agency's RN provided the onsite supervision for the CHHA no less frequently than every 14 days to ensure quality of care and services provided for two of 10 sampled patients (Patients 2 and10 ), creating the risk of substandard health outcomes to these patients. 1. Review of Patient 2's closed clinical record was initiated on 12/7/21. The clinical record showed the SOC was 6/18/21. The patient was certified for home health services during the certification period from 6/18/21 to 8/16/21. The POC, for the certification period from 6/18/21 to 8/16/21, showed CHHA visits 1W4 to start on 6/20/21. Review of the CHHA notes dated 6/23, 6/28,7/8 and 7/15/21, showed the CHHA provided care and services as ordered. However, there was no documented evidence the agency's RN provided supervision to the CHHA no less frequently than every 14 days. On 12/15/21 at 1457 hours, an interview with concurrent closed clinical record review was conducted with LVN2. LVN 2 was asked about the frequency of the supervisory visit for the CHHA. LVN 2 stated the supervisory visit was conducted once a month. LVN 2 was informed and acknowledged the finding 2. Review of Patient 10's clinical record was initiated on 12/10/21. The clinical record showed the SOC was 3/22/20. The patient was certified for home health services during the certification periods from 9/13/21 to 11/11/21 and 11/12/21 to 1/10/22. Review of the POC, for the certification periods from 9/13/21 to 11/11/21 and 11/12/21 to 1/10/22, cited SN visits 1W9 for all body system assessments. The POC also showed CHHA visits 1W9 to assist with the ADL care, personal care and hygiene, skin/foot care, grooming and bathing, ambulation exercise, and light housekeeping. Review of the CHHA visit notes dated 9/14, 9/22, 10/4, 10/11, 10/20, 10/25, 11/1, and11/8/21, showed the CHHA performed the assignment as cited in the POC. However, review of the CHHA supervisory Visit form undated failed to show documented evidence the agency's RN provided supervision to the CHHA no less frequently than every 14 days. On 12/15/21 at 1245 hours, an interview with concurrent closed clinical record review was conducted with LVN2. LVN 2 was asked about the frequency of the supervisory visit for the CHHA. LVN 2 stated the supervisory visit was not done. The supervisory visit should have been conducted on 9/27/21, for the whole certification period. She further stated the supervisory visit is due monthly. LVN 2 was informed and acknowledged the findings.

Licensing CFR(s): 484.100(b) (b) Standard: Licensing. The HHA, its branches, and all persons furnishing services to patients must be licensed, certified, or registered, as applicable, in accordance with the state licensing authority as meeting those requirements. This STANDARD is not met as evidenced by: Based on document review and interview, the agency failed to ensure the written agreements for the contracted rehabilitation companies (Companies 1 and 2) providing PT, OT, and ST services included the rights and responsibilities of the agency or contracted provider in the patient admission process. Findings: Title 22 Division 5 Chapter 6 Article 4 74719 titled Services Arranged by Agreement. When a service offered by the agency is not provided by employees, there shall be a written agreement meeting the requirements of this section. The agreement shall include at least the following: The role, if any, of the agency and the contracted individual or agency in the patient admission process. 1. Review of the written agreement between the agency and Company 1 providing PT, OT, and ST services was conducted on 12/15/21. The written agreement failed to include the rights and responsibilities of the agency or contracted provider in the patient admission process. On 12/15/21 at 1259 hours, the HR manager was informed and acknowledged the findings. 2. Review of the written agreement between the agency and Company 2 providing PT services was conducted on 12/15/21. The written agreement failed to include the rights and responsibilities of the agency or contracted provider in the patient admission process. On 12/15/21 at 1259 hours, the HR manager was informed and acknowledged the findings.

Laboratory services/CLIA waivers CFR(s): 484.100(c)(1) Laboratory services. If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient's equipment when assisting with self-administered tests. This STANDARD is not met as evidenced by: Based on interview and clinical record and document review, the agency failed to ensure the CLIA waiver certificate was current when conducting the blood glucose testing for one of 10 sampled resident (Patient 2) and one nonsampled resident (Patient A ), creating the risk of not meeting the regulatory standards related to laboratory testing. On 12/17/21 at 1030 hours, an entrance conference was conducted with the DPCS. The DPCS was asked to provide the agency's CLIA certificate of waiver. Review of the agency's CLIA certificate of waiver showed the effective date was 10/9/16, and the expiration date was on 10/8/18. On 12/8/21 at 1100 hours, an interview was conducted with the Administrator Designee. She stated the agency's CLIA certificate of waiver had expired. She stated the renewal application and payment were sent on 10/5/18, and the check was cashed on 10/15/18. She stated the agency did not receive the CLIA certificate of waiver which should be effective for the years of 2018 - 2020. She stated they had not applied for the renewal of CLIA certificate of waiver for the year of 2020 or after. On 12/15/21 at 1430 hours, an interview was conducted with the Administrator Designee. She stated the HHA sent an application and payment for the CLIA certificate of waiver on 12/14/21. Review of two clinical records for Patient A and Patient 2, showed an order to perform the blood glucose testing. However, the agency's CLIA waiver certificate was not current. For example: a. Review of Patient A 's closed clinical record was initiated on 12/15/21. The closed clinical record showed the SOC was 2/16/21. The patient was certified for home health services during the certification period from 2/16/21 to 4/16/21. The POC, for the certification period from 2/16/21 to 4/16/21, showed SN may perform BS check using the patient's glucometer PRN for any sign/symptoms of hypo/hyperglycemia. The SN note date 2/26 and 3/1/21, showed the SN checked the patient's BS level using the new glucometer bought by the nurse. b. Review of Patient 2 's closed clinical record was initiated on 12/7/21. The closed clinical record showed the SOC was 6/18/21. The patient was certified for home health services during the certification period from 6/18/21 to 8/16/21. The POC, for the certification period from 6/18/21 to 8/16/21, showed SN may perform BS check using the patient's glucometer PRN for any sign/symptoms of hypo/hyperglycemia. The POC showed to report the BS readings below 60 mg/dl and above 350 mg/dl to the physician. The SN note dated 6/29/21, showed LVN 4 conducted the SN visit. Documentation showed the patient's RBS level was 126 mg/dl. On 12/15/21 at 1000 hours, a telephone interview was conducted with LVN 4. LVN 4 was asked who conducted the patient's BS check on 6/29/21. She stated she did the BS testing. On 12/15/21 at 1500 hours, an interview and concurrent clinical record review was conducted with the DPCS. She was informed and acknowledged 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 clinical record review, the agency's Administrator failed to be responsible for the day to day operations related the P&P development and implementation, and maintain the current CLIA certificate of waiver. These failures created the risk of not providing quality of care and services to the patients receiving services from the HHA. Review of the agency's Job Description for Administrator showed the essential functions/responsibilities included planning and directing operations to ensure the provision of adequate and appropriate care and services; ensuring organizational compliance with legal, regulatory, and accreditation standards; evaluating services and programs; and ensuring that appropriate service policies are developed and implemented. 1. Review of the agency's P&P titled Wound Assessment and Documentation undated showed to inspect and evaluate the condition of the wound in the following manner: assess the wound location and it's size; measure the length, width, and depth; assess the color of the wound; assess wound drainage; assess wound color; stage the wound; assess wound odor; assess the surrounding skin for redness inflammation; evaluate the response to treatment. The agency's P&P titled Assessment/Staging of Pressure Ulcers dated 08/22, showed in assessing the pressure injury, the following parameters should be addressed consistently: site; stage of ulcer; size; presence of tunneling or undermining; presence of necrotic tissue; amount, color, and odor of drainage; granulation; pain; and condition of surrounding tissue. However, both P&Ps did not address how often the wound assessment including wound measurement should be performed. On 12/15/21 at 1209 hours, an interview and concurrent clinical record review was conducted with the DPCS. She stated the assessment are conducted weekly which includes completing the Wound Care Worksheet. She also stated when the SN would perform the wound care, the SN would assess for the signs and symptoms of infection. Review of the Wound Care Worksheet included assessing the location, type of wound, wound status, measurement, stage, tunneling, undermining, amount, odor of drainage, tissue of wound base, tissue of surrounding wound, and level of pain. 2. The agency's P&P titled Intravenous Therapy protocol dated 08/22 showed to change the IV site every 72 hours and PRN if dislodged. The agency's P&P titled Documentation of Infusion Therapy dated 08/22 showed the medical records shall include sufficient information to identify the procedures, treatments, complications, intervention, and outcomes of the prescribed infusion therapy. All documentation should be factual, accurate, and legible. Review of Patient 4's clinical record was initiated on 12/7/21. The clinical record showed the SOC was 10/10/21. The patient was certified for home health services during the certification period from 10/10/21 to 12/8/21. Review of the resumption of care comprehensive assessment showed dated 11/1/0/21, showed the patient had an IV peripheral line. The physician's order dated 11/10/21, showed Meropenem 500 mg /100 NS infuse over 30 minutes IV once QD for 10 days (11/10/21 to 11/19/21). The order showed the dialysis nurse to give dose during the dialysis days. The SN note dated 11/11/21, showed the patient had a saline lock to the right forearm from the hospital. Documentation showed the patient was seen for IV antibiotic infusion for UTI. The note showed the patient was discharged from the hospital on 11/9/21. The SN note dated 11/13, 11/16, 11/17, and 11/18/21, showed the patient had the right forearm IV site. The SN note dated 11/14/21, showed the patient's IV site was intact. The SN note dated 12/3/21, showed to follow-up on the "IV line on right forearm if d/c." * However, there was no documented evidence the IV peripheral line was changed very 72 hours as per the agency's P&P. There was no documented evidence of the status of the right forearm IV site after the last SN assessment on 11/18/21. There was no documented evidence showing when the right forearm IV site site was discontinued. On 12/15/21 at 1209 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the finding. The DPCS stated the patient's IV site on the right forearm was the same IV site from the hospital. The DPCS stated the right forearm IV site should have been discontinued during the SN visit after the last dose of IV antibiotic given at the dialysis center on 11/19/21. 3. Review of six clinical records for Patients 2, 4, 5, 7, and 8 showed the wound photographs in their clinical record. However, there was no documented evidence of a P&P addressing the wound photography. For example: a. Review of Patient 7's clinical record was initiated on 12/9/21. The clinical record showed the SOC was 10/22/21. The patient was certified for home health services during the certification period from 10/22/21 to 12/20/21. A joint home visit with LVN 1 was conducted on 12/8/21 at 1300 hours, to Patient 7's home. LVN 1 conducted the wound assessment and provided care to the patient's left buttock excoriation and mid back wounds. LVN 1 stated the patient's mid back wound was healed. LVN 1 took the photograph of the patient's left buttock excoriation and mid back wounds. Review of the clinical record showed a wound photograph dated 10/22/21, of the patient's back area and sacral/buttock area. b. Review of Patient 4's clinical record was initiated on 12/7/21. The clinical record showed the SOC was 10/10/21. The patient was certified for home health services during the certification period from 10/10/21 to 12/8/21. The POC, for the certification period from 10/10/21 to 12/8/21, showed to cleanse Stage 1 sacrococcygeal pressure injury with NS, pat dry, apply Calmoseptine (moisture barrier), cover with a foam dressing three times a week for two weeks. Review of the clinical record showed the wound photograph of the patient's sacral area dated 10/10/21. On 12/15/21 at 1230 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS stated the HHA would encourage the staff to take wound photograph. The DPCS stated the wound would be photographed during the comprehensive assessment, weekly, and change of condition. When asked if there was a P&P addressing the wound photography. She stated no. The DPCS was informed and acknowledged the findings. 4. Review of the agency's CLIA certificate of waiver showed the effective date of 10/9/16, and expiration date of 10/8/18 On 12/8/21 at 1100 hours, an interview was conducted with the Administrator Designee, She stated the agency's CLIA certificate of waiver expired. She stated the renewal application and payment was sent on 10/5/18, and the check was cashed on 10/15/18. She stated the agency did not receive the CLIA certificate of waiver which should be effective for the years 2018 to 2020. She stated they had not applied for the renewal of CLIA certificate of waiver. On 12/15/21 at 1430 hours, an interview was conducted with the Administrator Designee. She stated they had sent an application and payment for the CLIA certificate of waiver on 12/14/21. The Administrator Designee stated the Administrator was responsible to ensure the HHA's CLIA certificate of waiver current.

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 clinical record review, the agency failed to ensure the discharge summary for three of 10 sampled patients (Patients 1, 2, and 3) were completed. This deficient practice created the risk of risk of substandard care provided to these patients as their clinical information were not accurate and complete. 3. Review of Patient 2's closed clinical record was initiated on 12/7/21. The clinical record showed the SOC was 6/18/21. The patient was certified for home health services during the certification period from 6/18/21 to 8/16/21. The POC, for the certification period from 6/18/21 to 8/16/21, cited SN visits 1W1, 2W2, and 1W6 to perform assessment of all body systems. The POC also included PT evaluation and CHHA visits 1W4. Review of the Discharge OASIS assessment dated 7/20/21, showed the discharge summary for the certification period from 6/18/21 to 8/16/21. However, review of the Discharge OASIS assessment failed to show documented evidenced of the visit frequency of the SN, PT, and CHHA and the list of the medications. Further review of the closed clinical record failed to show documented evidenced the discharge summary was sent to the physician. On 12/15/21 at 1457 hours, an interview with concurrent closed clinical record review was conducted with the DPCS and LVN 2. They were asked if the visit frequency and medication list were included in the discharge summary. The DPCS stated they were not included in the document. When asked if the discharge summary was sent to the physician. The DPCS stated their fax machine did not have the capability to show the discharge summary was sent and received by the physician. They were informed and acknowledged the findings. 2. Review of Patient 1's closed clinical record was initiated on 12/9/21. The clinical record showed the SOC was 2/22/21. The patient was certified for home health services during the certification period from 2/22/21 to 4/22/21. Review of Patient 1's discharge comprehensive assessment dated 4/22/21, showed Patient 1 was discharged because the patient- centered goals had been achieved. Further review of the comprehensive discharge assessment failed to show the medications that Patient 1 was on at the time of discharge. On 12/15/21 at 1202 hours, an interview and concurrent medical record review was conducted with LVN 3. LVN 3 was informed and acknowledged the findings. 1. Review of Patient 3's closed clinical record was initiated on 12/9/21. The closed clinical record showed the SOC was 10/1/21. The patient was certified for home health services during the certification period from 10/1/21 to 11/29/21. The Discharge Summary dated 11/24/21, showed the patient was discharged on 11/24/21. * However, there was no documented evidence of the patient's discharge summary to include the frequency of service and medications that the patient was on at the time of discharge. On 12/15/21 at 1315 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged 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 clinical record review, the agency failed to ensure the clinical record was completed for one of 10 sampled patient (Patient 4), creating the risk of not appropriately authenticating the contents of the patient's clinical record. Review of Patient 4's clinical record was initiated on 12/7/21. The clinical record showed the SOC was 10/10/21. The patient was certified for home health services during the certification period from 10/10/21 to 12/8/21. Review of the SN notes dated 10/12, 10/22, 10,25. 10/27, 10/29, and 11/1/21, showed no documented evidence of an electronic signature of the visiting SN. On 12/15/21 at 1209 hours, an interview and concurrent clinical record review was conducted with the DPCS. The DPCS was informed and acknowledged the findings.