Every finding on record at Act Home Health , 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 2/6/25 at 0730 hours. The home health agency identified the census as 51. The survey sample size was 7. The agency was found to be in compliance with the HHA Emergency Preparedness requirements.

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 2/6/25 at 0730 hours. The home health agency identified the census as 51. The survey sample size was 7. GLOSSARY AND DEFINITIONS: AFO: ankle foot orthosis Asthma: a chronic lung disease that inflames and narrows the airways causing recurring periods of wheezing, chest tightness, shortness of breath and coughing; if untreated, an asthma attack can lead to death BIPAP: bilevel positive air pressure (a noninvasive mode of ventilation administered through a tight-fitting mask to assist spontaneously breathing) BP: Blood Pressure bpm: beats per minute(s) CEO: Chief Executive Officer CDC: Centers for Disease Control and Prevention colostomy: a surgical procedure that brings one end of the large intestine out through an opening (stoma) made in the abdominal wall corticosteroid: are strong, fast-acting anti-inflammatory medications DME: durable medical equipment DPCS: Director of Patient Care Services gm: gram(s) GI: Gastrointestinal tract GT: Gastrostomy Tube (a tube inserted through the abdominal wall into the stomach to provide nutrition, hydration, and medications) HHA: Home Health Agency I&O: Intake and Output IVIG: intravenous immunoglobulin (a medical treatment that involves administering purified antibodies [immunoglobulins] directly into the bloodstream through an intravenous infusion) LVN: Licensed Vocational Nurse MAR: Medication Administration Record mg: milligram(s) ml: milliliter(s) nebulizer: an electrically powered machine that turns liquid medication into a mist so that it can be breathed directly into the lungs through a face mask NJT: nasojejunal tube (a thin tube that's inserted through the nose and into the small intestine) OASIS: Outcome and Assessment Information Set Omphalocele: a birth defect in which an infant's intestine or other abdominal organs are outside of the body because of a hole in the belly button P&P: Policy and Procedure PCG: Patient Caregiver POC: Plan of Care PRN: As Needed QAPI: Quality Assurance and Performance Improvement Q: Every RN: Registered Nurse ROC: resumption of care ROM: range of motion SN: Skilled Nursing/Nurse SOC: Start of Care Trachea: the airway that leads from the larynx to the bronchi Tracheitis: an inflammation of the trachea Tracheostomy: a surgically created opening through the neck into the trachea (windpipe) to create an airway and to remove secretions from the lungs Tracheostomy ties: ties used to hold the tracheostomy in place URI: Upper Respiratory Infection Urinary catheter: a flexible tube that is drains out urine from bladder out into a collection bag UTI: Urinary Tract Infection Vest APX Clearance System: a medical device used for airway clearance therapy that utilizes high frequency wall oscillation technology to loosen and mobilize mucus in the airways by vibrating a wearable vest against the chest, allowing for easier coughing and suctioning of secretions

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 interview and record review, the agency failed to ensure the OASIS data was transmitted within 30 days of completing the OASIS data sets. This failure had the potential for not reporting and coordinating the patient care assessment timely for the patients receiving care and services at the agency. Findings: Review of the OASIS validation reports from 8/2024 to 1/2025 was initiated on 2/13/25, and showed the following: The agency’s OASIS Agency Final Validation reports from 8/2024 showed there were 38 OASIS data sets submitted more than 30 days from the assessment completion date. The agency’s OASIS Agency Final Validation reports from 9/2024 showed there were nine OASIS data sets submitted more than 30 days from the assessment completion date. The agency’s OASIS Agency Final Validation reports from 1/2025 showed there were five OASIS data sets submitted more than 30 days from the assessment completion date. On 2/18/25 at 0907 hours, an interview and concurrent agency document review was conducted with the CEO/Administrator Designee. The CEO/Administrator Designee was informed and acknowledged the above findings.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the initial comprehensive assessment was completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the SOC date for one of seven sampled patients (Patient 2). This failure had the potential to not identify and address the care needs timely for this patient. Findings: Review of Patient 2's clinical record was initiated on 2/6/25. The clinical record showed the SOC was 11/2/23. The patient was certified for home health services during the certification period from 12/29/24 to 2/26/25. The OASIS E SOC/ROC assessment dated 11/5/23, showed the RN performed the initial comprehensive assessment. However, there was no documented evidence the RN obtained the patient’s vital signs for the comprehensive assessment. On 2/18/25 at 0932 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She 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 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 two of seven sampled patients (Patients 6 and 7). This failure posed the risk to not identify the potential adverse effects, significant drug interactions, duplicate drug therapy, and drug reactions for these patients. Findings: #. Clinical record review for Patient 7 was initiated on 2/6/25. The clinical record showed the SOC was 5/24/24. The patient was certified for home health services during the certification periods from 11/20/24 to 1/18/25 and 1/19/25 to 3/19/25. The Medication Profile for the certification period from 1/19/25 to 3/19/25, showed the patient’s medication included budesonide (corticosteroid drug that treats asthma, allergies, COPD, and other inflammatory conditions) 0.5 mg/ 2 ml via nebulizer one vial (0.5 mg) twice daily at 0630 and 1300 hours. A joint home visit with the Administrator/DPCS and LVN 1 was conducted on 2/11/25 at 1120 hours, to Patient 7’s home. Review of the patient’s medications with LVN 1 was performed. LVN 1 verified the patient’s box of supply for the budesonide’s label showed dosage of 1 mg/ 2 ml instead of 0.5 mg / 2 ml. On 2/11/25 at 1121 hours, an observation and concurrent interview was conducted with the Administrator/DPCS. The Administrator/DPCS verified the above finding and stated she will update the patient’s medication profile. #. Review of Patient 6's clinical record was initiated on 2/12/25. The clinical record showed the SOC was 3/25/22. The patient was certified for home health services during the certification periods from 10/20/24 to 12/18/24 and to 12/19/24 to 2/16/25. The Medication Profile for the certification period from 12/19/24 to 2/16/25, showed the patient's medications included Ibuprofen (nonsteroidal anti-inflammatory drug) 400 mg 0.5 tablet PRN Q six hours PRN for fever/mild to moderate pain and metoclopramide (antiemetic) 5 mg 0.5 tablet PRN Q six hours for gastric motility and/or sign and symptoms of nausea and vomiting. A joint home visit with the Administrator/DPCS and LVN 2 and was conducted on 2/11/25 at 0845 hours, to Patient 6’s home. The family member stated the patient no longer takes ibuprofen and metoclopramide. * However, the patient’s medication profile was not updated to reflect the patient’s current medications. On 2/18/25 at 0852 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She 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 interview and record review, the agency failed to ensure the comprehensive assessments were updated within the last five days of every 60 days for two of seven sampled patients (Patients 2 and 5 ). This failure had the potential for not addressing the care needs for these patients. Findings: 1. Review of Patient 5's clinical record was initiated on 2/12/25. The clinical record showed the SOC was 3/10/23. The patient was certified for home health services during the certification periods from 10/30/24 to 12/28/24 and to 12/29/24 to 2/26/25. The OASIS E Recertification assessment dated 10/29/24, failed to show documented evidence the patient’s BP was checked. The OASIS E Recertification assessment dated 12/26/24, failed to show documented evidence the patient’s vital signs were checked. On 2/18/25 at 0815 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. 2. Review of Patient 2's clinical record was initiated on 2/6/25. The clinical record showed the SOC was 11/2/23. The patient was certified for home health services during the certification period from 12/29/24 to 2/26/25. The OASIS E Recertification assessment dated 12/26/24, failed to show no documented evidence the patient’s vital signs were checked. In addition, there was no documented evidence the patient’s bowel sounds were auscultated. On 2/18/25 at 0932 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She 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 observation, interview, and record review, the agency failed to ensure the POCs included specific information related to medications, nutritional requirement, DME, and supplies for four of seven sampled patients (Patients 1, 2, 4, and 6). This failure had the potential for not addressing the care needs for these patients. Findings: #. Clinical record review for Patient 1 was initiated on 2/6/25. The clinical record showed the SOC was 11/1/21. The patient was certified for home health services during the certification periods from 10/16/24 to 12/14/24 and 12/15/24 to 2/12/25. The POC, for the certification periods from 10/16/24 to 12/14/24 and 12/15/24 to 2/12/25, in the medication section of the POC, showed to administer Gamunex (immune globulin) 52.5 Gm (525 ml) infuse via pump over at least 10 hours and 57 minutes daily for two day every four weeks and perform vital signs as ordered and clinically indicated during IVIG infusion. However, the POC did not specify when it was clinically indicated to perform vital signs during IVIG infusion. On 2/18/25 at 0830 hours, the CEO/Administrator Designee was informed and acknowledged the finding. #. Closed clinical record review for Patient 4 was initiated on 2/12/25. The clinical record showed the SOC was "11/29/23." The patient was certified for home health services during the certification periods from 11/30/23 to 1/28/24 and 1/29/24 to 3/28/24. The patient was discharged from the agency on 3/15/24. Review of the POC, for the certification period from 1/29/24 to 3/28/24, in the medication section, showed to administer lactulose (laxative) 10 Gm/15 ml via NJT two times daily as needed for constipation and administer the second dose as needed for soft stool. However, there was no indication when to administer the first dose. Review of the MAR for the month of December 2023 showed Patient 4 was administered lactulose on 12/4, 12/7, and 12/9/23; and Glycerin on 12/11/23. On 2/18/25 at 0830 hours, the CEO/Administrator Designee was informed and acknowledged the finding. On 2/18/25 at 1100 hours, the Administrator/DPCS stated provided the physician's order for lactulose and stated the indication for the second dose was for soft stool. When asked regarding the indication of the first dose, she acknowledged there was no documentation on the indication of the first dose. 3. Review of Patient 6's clinical record was initiated on 2/12/25. The clinical record showed the SOC was 3/25/22. The patient was certified for home health services during the certification periods from 10/20/24 to 12/18/24 to 12/19/24 to 2/16/25. The agency’s P&P titled Medication Administration and Enteral Feedings: Gastrostomy Tube dated 08/22, showed for feedings: - Put patient in semi-fowlers position. Keep her in this position during enteral administration and for at least 30 minutes afterward. - Remove GT plug and attach a 30 ml to 60 ml piston syringe. - Release the GT clamp. To verify tube placement and patency, aspirate for gastric contents, note the residual volume, and follow the facility’s policy for reinstilling. Clamp the GT, remove the syringe, and take out the plunger. - Reattach the syringe and unclamp the GT. Pinch the tubing to seal and add 30 ml of water to syringe, or physician prescribed amount of flush. Release the tubing, the water flow by gravity to flush it, and pinch it again before the syringe empties. - Pour the enteral feeding into the syringe and release the tubing to administer it. If you’re giving more than one drug, flush between each dose with 15 to 30 ml of water. The POC, for the certification period from 12/19/24 to 2/16/25, showed SN to administer feed as follows: administer Pediasure (nutritional supplement), water/hydration, and Pedialyte (electrolyte solution). The POC included enteral feeds and hydration in three divided increments to a total daily feeding volume of 1611 ml: Pediasure (nutritional supplement) 711 ml, water 540 ml, and Pedialyte (electrolyte solution) 360ml. Documentation showed to administer via GT bolus or on enteral pump over four hours at a rate of 60 ml per hour PRN for poor oral intake. A joint home visit with the Administrator/DPCS and LVN 2 and was conducted on 2/11/25 at 0845 hours, to Patient 6’s home. The following was observed: LVN 2 performed hand washing. LVN connected a large syringe filled with Pediasure to the patient’s GT. LVN administered the Pediasure-filled syringe by pushing the plunger of the syringe instead of by gravity. LVN disconnected the syringe from the GT. LVN performed the same procedure with another Pediasure-filled syringe and followed with another Pedialyte-filled syringe and followed lastly with a water-filled syringe. On 2/11/24 at 0845 hours, an interview was conducted with LVN 2. LVN 2 stated LVN 2 was instructed by the family member to push the plunger of the syringe when enteral/hydration feeding was administered. * However, the POC did not include to push the plunger of the syringe when enteral/hydration feeding was administered. On 2/18/25 at 0852 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. She stated the family member wanted to administer the enteral/hydration feeding by pushing the plunger to decrease reflux and ensure there would be no air entering via GT. 4. Review of Patient 2's clinical record was initiated on 2/6/25. The clinical record showed the SOC was 11/2/23. The patient was certified for home health services during the certification period from 12/29/24 to 2/26/25. The POC, for the certification period 12/29/24 to 2/26/25, cited LVN 272 to 280 hours/ 30 days for 60 days under a dual agency authorization with another HHA. The medications included apply zinc oxide “0.4 mg/mg” topical 1/2 inch "stripe" to bilateral gluteal regions PRN for irritation. * However, the POC did not include the frequency on the application of the zinc oxide. On 2/18/25 at 0932 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. Findings: 1. Clinical record review for Patient 1 was initiated on 2/6/25. The clinical record showed the SOC was 11/1/21. The patient was certified for home health services during the certification periods from 10/16/24 to 12/14/24 and 12/15/24 to 2/12/25. The POC, for the certification periods from 10/16/24 to 12/14/24 and 12/15/24 to 2/12/25, showed the medication section showing to administer Gamunex (immune globulin) 52.5 Gm (525 ml) infuse via pump over at least 10 hours and 57 minutes daily for two day every four weeks and perform vital signs as ordered and clinically indicated during IVIG infusion. However, the POC did not specify when it was clinically indicated to perform vital signs during IVIG infusion. On 2/18/25 at 0830 hours, the CEO/Administrator Designee was informed and acknowledged the finding. 2. Closed clinical record review for Patient 4 was initiated on 2/12/25. The clinical record showed the SOC was "11/29/23." The patient was certified for home health services during the certification periods from 11/30/23 to 1/28/24 and 1/29/24 to 3/28/24. The patient was discharged from the agency on 3/15/24. Review of the POC, for the certification period from 1/29/24 to 3/28/24, showed the medication section showing to administer lactulose (laxative) 10 Gm/15 ml via NJT two times daily as needed for constipation and administer the second dose as needed for soft stool. However, there was no indication when to administer the first dose. Review of the MAR for the month of December 2023 showed Patient 4 was administered lactulose on 12/4, 12/7, and 12/9/23; and Glycerin on 12/11/23. On 2/18/25 at 0830 hours, the CEO/Administrator Designee was informed and acknowledged the finding. On 2/18/25 at 1100 hours, the Administrator/DPCS provided the physician's order for lactulose and stated the indication for the second dose was for soft stool. When asked regarding the indication of the first dose, she acknowledged there was no documentation on the indication of the first dose. 3. The agency’s P&P titled Medication Administration and Enteral Feedings: Gastrostomy Tube dated 08/22 showed the following steps to administer feedings: - Put patient in semi-fowlers position. Keep her in this position during enteral administration and for at least 30 minutes afterward. - Remove GT plug and attach a 30 ml to 60 ml piston syringe. - Release the GT clamp. To verify tube placement and patency, aspirate for gastric contents, note the residual volume, and follow the facility’s policy for reinstilling. Clamp the GT, remove the syringe, and take out the plunger. - Reattach the syringe and unclamp the GT. Pinch the tubing to seal and add 30 ml of water to syringe, or physician prescribed amount of flush. Release the tubing, the water flow by gravity to flush it, and pinch it again before the syringe empties. - Pour the enteral feeding into the syringe and release the tubing to administer it. If you’re giving more than one drug, flush between each dose with 15 to 30 ml of water. Review of Patient 6's clinical record was initiated on 2/12/25. The clinical record showed the SOC was 3/25/22. The patient was certified for home health services during the certification periods from 10/20/24 to 12/18/24 to 12/19/24 to 2/16/25. The POC, for the certification period from 12/19/24 to 2/16/25, showed SN to administer feeding as follows: administer Pediasure (nutritional supplement), water/hydration, and Pedialyte (electrolyte solution). The POC included to provide enteral feeds and hydration in three divided increments to a total daily feeding volume of 1611 ml: Pediasure (nutritional supplement) 711 ml, water 540 ml, and Pedialyte (electrolyte solution) 360ml. Documentation showed to administer via GT bolus or enteral pump over four hours at a rate of 60 ml per hour PRN for poor oral intake. A joint home visit with the Administrator/DPCS and LVN 2 and was conducted on 2/11/25 at 0845 hours, to Patient 6’s home. The following was observed: LVN 2 performed hand washing. LVN connected a large syringe filled with Pediasure to the patient’s GT. LVN administered the Pediasure-filled syringe by pushing the plunger of the syringe instead of by gravity. LVN disconnected the syringe from the GT. LVN performed the same procedure with another Pediasure-filled syringe and followed with another Pedialyte-filled syringe and followed lastly with a water-filled syringe. On 2/11/24 at 0845 hours, an interview was conducted with LVN 2. LVN 2 stated LVN 2 was instructed by the family member to push the plunger of the syringe when enteral/hydration feeding was administered. * However, the POC did not include to push the plunger of the syringe when enteral/hydration feeding was administered. On 2/18/25 at 0852 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. She stated the family member wanted to administer the enteral/hydration feeding by pushing the plunger to decrease reflux and ensure there would be no air entering via GT. 4. Review of Patient 2's clinical record was initiated on 2/6/25. The clinical record showed the SOC was 11/2/23. The patient was certified for home health services during the certification period from 12/29/24 to 2/26/25. The POC, for the certification period 12/29/24 to 2/26/25, cited LVN 272 to 280 hours/30 days for 60 days under a dual agency authorization with another HHA. The medications included apply zinc oxide “0.4 mg/mg” topical 1/2 inch "stripe" to bilateral gluteal regions PRN for irritation. * However, the POC did not include the frequency on the application of the zinc oxide. On 2/18/25 at 0932 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure the provided treatment was included in the POC for one of seven sampled patients (Patient 7). This failure had the potential risk of not addressing the care needs for the patient. Findings: Clinical record review for Patient 7 was initiated on 2/6/25. The clinical record showed the SOC was 5/24/24. The patient was certified for home health services during the certification periods from 11/20/24 to 1/18/25 and 1/19/25 to 3/19/25. Review of the SN notes dated 12/20/24 at 0700 to 1500 hours and 1500 to 2200 hours, showed the SN applied the Vest APX Clearance System for a total of 20 minutes at 0900 and 2130 hours. The SN note dated 12/21/24 at 0900 to 2100 hours, showed the SN applied the Vest APX Clearance System for a total of 20 minutes at 0930 hours. The SN note dated 12/22/24 at 0830 to 2100 hours, showed the SN applied the Vest APX Clearance System for a total of 20 minutes at 0900 hours. The SN note dated 12/22/24 at 0730 to 1600 hours, showed the SN applied the Vest APX Clearance System for a total of 20 minutes at 0900 hours. * However, the POC, for the certification periods from 11/20/24 to 1/18/25, did not include the Vest APX Clearance System treatment. On 2/18/25 at 1154 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. The Administrator/DPCS was informed and acknowledged the above finding. The Administrator/DPCS stated there should be a supplemental physician’s order for the Vest APX Clearance System treatment; however, she was unable to provide documented evidence of a physician’s order for the above treatment.

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 interview and record review, the agency failed to ensure effective communication with the patient's physician for two of seven sampled patients (Patients 1 and 2). This failure had the potential for not providing necessary care and services to these patients. 2. Review of Patient 2's clinical record was initiated on 2/6/25. The clinical record showed the SOC was 11/2/23. The patient was certified for home health services during the certification period from 12/29/24 to 2/26/25. The SN note dated 12/31/24 (0600 hours to 1000 hours) and 1/1/24 (0600 hours to 1000 hours) showed the patient’s urine was clear, yellow, and had a mild odor. * However, there was no documented evidence the SN coordinated the presence of mild odor in the patient’s urine with the RN or the physician. On 2/18/25 at 0932 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. Findings: Clinical record review for Patient 1 was initiated on 2/6/25. The clinical record showed the SOC was 11/1/21. The patient was certified for home health services during the periods from 10/16/24 to 12/14/24 and 12/15/24 to 2/12/25. Review of the POC, for the certification periods 10/16/24 to 12/14/24 and 12/15/24 to 2/12/25, cited SN to perform clean intermittent catheterization at 1200 and 1500 hours. SN to insert indwelling urinary catheter at 2000 hours and remove the indwelling urinary catheter at 0800 hours. *Review of the SN note dated 12/15/24 at 0700 to 1900 hours, showed the SN had performed clean intermittent catheterization at 1100 hours with an output of 560 ml, at 1400 hours with an output of 440 ml, and at 1700 hours with an output of 320 ml. *Review of the SN note dated 12/18/24 at 1000 to 2100 hours, showed the SN had performed clean intermittent catheterization at 1200 hours with an output of 810 ml, at 1500 hours with an output of 420 ml, and at 1800 hours with an output of 210 ml. *Review of the SN note dated 12/28/24 at 1015 to 2115 hours, showed the SN had performed clean intermittent catheterization at 1200 hours with an output of 710 ml, at 1500 hours with an output of 410 ml, and at 1800 hours with an output of 260 ml. Further review of the clinical record failed to show documented evidence the RN had coordinated/consulted the physician regarding the need for a clean intermittent catheterization at 1800 hours. On 2/18/25 at 0830 hours, the CEO/Administrator Designee 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 ensure the standard precautions to prevent the transmission of infections and communicable diseases were implemented for two of sampled seven patients (Patients 6 and 7). This failure had the potential for spread of infections. Findings: #. According to the CDC recommendation, washing hands before and after using gloves to prevent the spread of germs. If soap and water are not available, you can use an alcohol-based hand sanitizer that contains at least 60% alcohol. Gloves are not a substitute for hand hygiene. Clinical record review for Patient 7 was initiated on 2/6/25. The clinical record showed the SOC was 5/24/24. The patient was certified for home health services during the certification periods from 11/20/24 to 1/18/25 and 1/19/25 to 3/19/25. A joint home visit with the Administrator/DPCS and LVN 1 was conducted on 2/11/25 at 1109 hours, to Patient 7’s home. LVN 1 was observed performing tracheostomy care to Patient 7. LVN 1 washed her hands prior to the tracheostomy care procedure and donned gloves to bilateral hands. LVN 1 removed her gloves after the tracheostomy care procedure. LVN 1 was asked if she was done with the tracheostomy care procedure and replied “yes.” *However, LVN 1 was not observed washing her hands after removing her gloves. LVN 1 continued with cleaning the bedside table. On 2/18/25 at 1045 hours, an interview was conducted with the Administrator/DPCS. The Administrator/DPCS was informed and acknowledged the above finding. 1. According to the CDC's Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings showed ensure proper selection and use of personal protective equipment (PPE) based on the nature of the patient interaction and potential for exposure to blood, body fluids and/or infectious material: - Wear gloves when it can be reasonably anticipated that contact with blood or other potentially infectious materials, mucous membranes, non-intact skin, potentially contaminated skin or contaminated equipment could occur. Review of Patient 6's clinical record was initiated on 2/12/25. The clinical record showed the SOC was 3/25/22. The patient was certified for home health services during the certification periods from 10/20/24 to 12/18/24 and 12/19/24 to 2/16/25. The POC, for the certification period from 12/19/24 to 2/16/25, showed SN to administer feed as follows: administer Pediasure (nutritional supplement), water/hydration, and Pedialyte (electrolyte solution). The POC included enteral feeds and hydration in three divided increments to a total daily feeding volume of 1611 ml: Pediasure (nutritional supplement) 711 ml, water 540 ml, and Pedialyte (electrolyte solution) 360ml. Documentation showed to administer via GT bolus or on enteral pump over four hours at a rate of 60 ml per hour PRN for poor oral intake. A joint home visit with the Administrator/DPCS and LVN 2 and was conducted on 10/11/25 at 0845 hours, to Patient 6’s home. The following was observed: LVN 2 performed hand washing. LVN connected a large syringe filled with Pediasure to the patient’s GT. LVN administered the Pediasure-filled syringe. LVN disconnected the syringe from the GT. LVN performed the same procedure with another Pediasure-filled syringe and followed with another Pedialyte-filled syringe and followed lastly with a water-filled syringe. * However, the LVN did not don gloves when the syringe was connected and disconnected from the GT; and when the LVN administered Pediasure, Pedialyte, and water via GT. On 2/18/25 at 0852 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to implement and maintain the infection control program which included surveillance, identification, prevention, control, and investigation of infections. This failure had the potential for the transmission of infections to the staff, caregivers, and vulnerable patients in their homes. Findings: Review of the agency’s P&P titled Infection Prevention and Control dated 1/2019 showed the staff strategies for preventing and controlling infection transmission. The staff will be responsible for infection prevention and control activities by conducting infection surveillance, identification, and reporting activities. All infection control data will be reported and addressed by the QAPI Committee. Review of the QAPI Meeting Minutes dated 12/14/22, showed the description of the patient and employee infection report findings for the fourth quarter/annual of 2022. The meeting minutes showed the patients' infections included 12 cases with UTIs, two cases with eye infection, five cases with intestinal infection, and one case with dog bite. However, review of the agency’s fourth quarter/annual data aggregation for 2022 showed incomplete information as it only showed the data aggregation for the months of January and February of 2022. In addition, there was no documented evidence the agency had analyzed the data, investigated for possible causes of infection, tracked patterns, and trends of infection, and implemented specific actions to minimize infections to improve care practices and control the transmissions of infection among staff, caregiver, and patients. Furthermore, there was no documented evidence the infection control data was reported and addressed by the QAPI Committee for the first, second, and third quarters. Review of the QAPI Meeting Minutes dated 12/8/23, showed the description of the patient and employee infection report findings for the fourth quarter/annual of 2023. The meeting minutes showed the patients' infections included 20 cases with UTI, 10 cases with URI, four case with GI, four with ear infection, one case with skin infection, one case with tracheitis, one case with wound infection, one case with testicular infection, one case with eye infection, and one case with oral infection. However, there was no documented evidence the agency had analyzed the data, investigated for possible causes of infection, tracked patterns and trends of infection, and implemented specific actions to minimize infections to improve care practices and control the transmissions of infection among staff, caregiver, and patients. In addition, there was no documented evidence the infection control data was reported and addressed by the QAPI Committee for the first, second, and third quarters. Review of the QAPI Meeting Minutes dated 10/3/24, showed the description of the patient and employee infection report findings for the third quarter of 2024. The meeting minutes showed there were four patients with UTIs wherein two patients with UTIs were long-term urinary catheter dependent patients. However, review of the agency’s third quarter data aggregation for 2024 showed there were three UTIs and one URI which was inconsistent with the QAPI meeting minutes. Review of the QAPI Meeting Minutes dated 12/20/24, showed the description of the patient and employee infection report findings for the fourth quarter/annual of 2024. The meeting minutes showed there were four patients with UTIs wherein two patients with UTIs were long-term urinary catheter dependent patients. However, review of the agency’s fourth quarter/annual data aggregation for 2024 showed there were two UTIs and two URIs which was inconsistent with the QAPI meeting minutes. On 2/13/25 at 1304 hours, an interview and concurrent agency document review was conducted with the Administrator/DPCS. The Administrator/DPCS stated she was unable to retrieve the complete raw data, infection reports, and QAPI meeting minutes for the years of 2022 and 2023 because their software system was new and the old documentation was not maintained. On 2/18/25 at 0920 hours, an interview was conducted with the CEO/Administrator Designee. The CEO/Administrator Designee was informed and acknowledged the above findings. The CEO/Administrator Designee stated the staff will input infection information in their system when infection was identified. The CEO/Administrator Designee stated Administrator/DPCS will then generate, analyze, and report infection control and prevention data for the QAPI meeting.

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 plan of care for seven of seven sampled patients (Patients 1, 2, 3, 4, 5, 6, and 7). This failure had the potential for not providing appropriate, consistent, and quality care to these patients. 5. Review of Patient 6's clinical record was initiated on 2/12/25. The clinical record showed the SOC was 3/25/22. The patient was certified for home health services during the certification periods from 10/20/24 to 12/18/24 and to 12/19/24 to 2/16/25. a. The POC, for the certification period from 10/20/24 to 12/18 24, showed the following: - SN/PCG to perform GT care each shift and PRN using clean technique by cleaning with soap and warm water or normal saline to keep stoma clean, pat dry, and place gauze dressing around site and PRN for excess drainage. The POC showed to document condition of site. - SN to reposition Q two hours unless connected to BIPAP during sleeping hours and PRN. Document tolerance, position, and safety measures - Perform active/passive ROM three times daily at 0900, 1300, and 1900 as tolerated. - Document number of voids throughout the shift in the I&O record. Document urine color, size and clarity of urine. * The SN notes dated 10/20 (1600 hours to 0800 hours), 10/21 (0800 hours to 1400 hours), 10/21 (1600 hours to 0800 hours), 10/22 (1600 hours to 0800 hours), and 10/23 (0800 to 1400 hours), and 10/23/24 (1600 hours to 0800 hours), showed no documented evidence the SN performed GT care Q shift and documented the condition of the site as per the POC. The SN note dated 10/23/24 (0800 hours to 1400 hours), showed at 0800 and 1200 hours, the patient had “Urine Count: 1.” * However, there was no documented evidence of what was the urine color, size and clarity of urine as per the POC. The SN note dated 10/23/24 (0800 hours to 1400 hours), showed the SN repositioned the patient at 0800, 1000, and 1400 hours. * However, there was no documented evidence the patient was repositioned Q two hours at 1200 hours. The SN note dated 10/23/24 (0800 hours to 1400 hours), showed at 1300 hours active/passive ROM was performed. * However, there was no documented evidence active/passive ROM was performed at 0900 hours as per the POC. b. The POC, for the certification period from 12/19/24 to 2/1/25, showed the following: - SN/PCG to perform GT care each shift and PRN using clean technique by cleaning with soap and warm water or normal saline to keep stoma clean, pat dry, and place gauze dressing around site and PRN for excess drainage. The POC showed to document condition of site. - Document number of voids throughout the shift in the I&O record. Document urine color, size and clarity of urine. * The SN note dated 12/19/24 (0800 hours to 1600 hours), 12/19 (1600 hours to 0800 hours), 12/20 (0800 hours to 1600 hours), 12/20 (1600 hours to 0800 hours), 12/21 (1600 hours to 0800 hours), and 12/23/24 (0800 hours to 1600 hours), showed no documented evidence the SN performed GT care Q shift and documented the condition of the site. The SN note dated 12/20/24 (0800 hours to 1600 hours) showed at 0800, 1200, and 1500 hours the “Urine Count: 1.” * However, there was no documented evidence of what was the urine color, size and clarity of urine as per the POC. On 2/18/25 at 0852 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. 6. Review of Patient 5's clinical record was initiated on 2/12/25. The clinical record showed the SOC was 3/10/23. The patient was certified for home health services during the certification periods from 10/30/24 to 12/28/24 and to 12/29/24 to 2/26/25. a. The POC, for the certification period from 10/30/24 to 12/28/24, showed the following: - Perform vital signs: temperature, pulse, respiratory rate, blood pressure, and pain every shift during initial assessment and PRN complications. - SN to administer feed as follows: Nutren 1.5 cal (nutritional supplement) 250 ml via GT slow gravity bolus four times a day at 0730, 1030, 1430, and 1800 hours. May give 125 mL and then wait one hour before administering remaining 125 ml to ensure patient tolerance and reduce reflux/emesis. Flush GT with 60 ml to 180 ml water after each feeding. * The SN dated 10/30 (0700 hours to 1500 hours), 10/31 (0700 hours to 1500 hours), 11/1 (0000 hours to 0800 hours), 11/1 (0800 hours to 1615 hours), and 11/1/24 (1615 hours to 0000 hours), showed no documented evidence the patient’s BP was obtained as per the POC. * The SN note dated 10/30/24 (0700 hours to 1500 hours), showed at 0815, 1115, and 1430 hours, Nutren 250 ml via GT was administered. Documentation showed GT was flushed with 200 ml of water instead of 60 to180 ml of water The SN note dated 10/31/24 (0700 hours to 1500 hours), showed at 0715, 1030, and 1415 hours, Nutren 250 ml via GT was administered. Documentation showed GT was flushed with 200 ml of water instead of 60 to180 ml of water The SN note dated 11/1/24 (0000 hours to 0800 hours), showed at 0640 hours, Nutren 250 ml via GT was administered. Documentation showed GT was flushed with 200 ml of water instead of 60 to180 ml of water. b. The POC, for the certification period from 12/29/24 to 2/26/25, showed the following: - Perform vital signs: temperature, pulse, respiratory rate, blood pressure, and pain every shift during initial assessment and PRN complications. - Cleanse GT stoma site 1/2 strength hydrogen peroxide and water, and leave open to air every shift & PRN soiling: * The SN dated 12/30 (0800 hours to 1530 hours), 12/30 (1530 hours to 2200 hours), 12/31 (0900 hours to 1500 hours), and 12/31/24 (1500 hours to 2000 hours) and 1/2/25 (1500 hours to 2300 hours), showed no documented evidence the patient’s BP was obtained as per the POC. The SN note dated 12/31/24 (0900 hours to 1500 hours), showed no documented evidence the SN cleansed the GT stoma site 1/2 strength hydrogen peroxide and water, and left open to air. On 2/18/25 at 0815 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. #. Review of Patient 2's clinical record was initiated on 2/6/25. The clinical record showed the SOC was 11/2/23. The patient was certified for home health services during the certification period from 12/29/24 to 2/26/25. The OASIS E Recertification assessment dated 12/26/24, showed the patient had a left buttock skin tear. Documentation showed the treatment was Duoderm (wound dressing). The physician’s order dated 12/26/24, showed to cleanse small left buttock skin tear with normal saline, pat dry, apply a Mepilex Border flex (wound dressing) self-adherent soft silicone foam dressing Q two to three days and PRN for soiling/dislodgement until healed. * However, the treatment in the OASIS E Recertification assessment was not consistent with the physician’s order dated 12/26/24. The POC, for the certification period from 12/29/24 to 2/26/25, cited LVN 272 to 280 hours/ 30 days for 60 days under a dual agency authorization with another HHA. The POC showed the following information: - Tracheostomy care included change tracheostomy cannula and cleanse tracheostomy site each shift and PRN soiling. - Perform vital signs: temperature, pulse, respiratory rate, BP, and pain Q shift during initial assessment and PRN complications. - Physician notification data: pulse greater than 120; pulse less than 60 * The SN note dated 12/29/24 (1800 hours to 2200 hours), 12/31/24 (1800 hours to 2200 hours), and 1/1/25 (1800 hours to 2200 hours) showed no documented evidence tracheostomy site was cleansed as per the POC. The SN note dated 12/31/24 (0600 hours to 1000 hours), showed on the initial assessment the patient’s apical pulse was irregular and 56 beats/minute. Documentation showed will monitor. Documentation showed at 0835 hours, the patient was not in distress and the heart rate was low. Documentation showed will monitor. * However, there was no documented evidence the physician was notified related to the patient’s apical pulse less than 60 beats per minute as per the POC. On 2/18/25 at 0932 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. # Clinical record review for Patient 7 was initiated on 2/6/25. The clinical record showed the SOC was 5/24/24. The patient was certified for home health services during the certification periods from 11/20/24 to 1/18/25 and 1/19/25 to 3/19/25. a. The POC, for the certification period 11/20/24 to 1/18/25, showed LVN visits 480 hours Q 30 days for 60 days (starting with day 1 of authorization period between the dates of 09/21/24-10/20/24 increase in hours). Review of the physician’s order dated 2/5/25, showed an increased in hours for patient staffed at 530.5 hours out of 480 hours Medical LVN hours between the dates of 12/20/24-1/18/25. * However, review of the SN notes dated 12/20/24 to 1/18/25, showed the LVN visited the patient 508.5 hours in 30 days instead of 530.5 hours as per the physician’s order. On 2/18/25 at 1022 hours, an interview and concurrent agency document review was conducted with the CEO/Administrator Designee. The CEO/Administrator Designee was informed and acknowledged the above finding. b. The POC, for the certification period 1/19/25 to 3/19/25, showed orders for discipline and treatments for SN to perform tracheostomy care, to cleanse tracheostomy cannula and tracheostomy site each shift and PRN soiling. Cleanse with 1/2 strength hydrogen peroxide (3%) and sterile water. Rinse with sterile water and air dry, cover stoma with trach sponge. Change tracheostomy ties following tracheostomy care every morning. During the home visit observation on 2/11/25 conducted with LVN 1 and Patient 7 between 1100 to 1135 hours, the following was identified: - LVN 1 washed her hands. - LVN 1 told Patient 7 she will do his tracheostomy care. - LVN 1 prepared a bedside table next to patient 7’s bed, opened a tracheostomy care kit, and squeezed the hydrogen peroxide liquid bottle and sterile water liquid bottle together in a container inside the tracheostomy care kit. - LVN 1 stated she did measure the amount of the hydrogen peroxide and sterile water and will eyeball the amount of liquid. - LVN 1 proceeded in swabbing around Patient 7’s tracheostomy site with a cotton swab soaked with the hydrogen peroxide and sterile water solution. - LVN 1 fanned Patient 7’s tracheostomy site with her hand and an individual square gauze pad packet to dry. -LVN 1 placed the dressing in the tracheostomy site. * However, LVN 1 did not measure the amount of hydrogen peroxide or sterile water for the dose of ½ strength solution or allow the tracheostomy site to air dry after cleaning as per the POC. On 2/18/25 at 1045 hours, an interview was conducted with the Administrator/DPCS. The Administrator/DPCS was informed and acknowledged the above finding. c. The POC, for the certification period 1/19/25 to 3/19/25, showed orders and treatments for SN to administer cough assist as follows: 3x daily and every 4 hours PRN, as tolerated, after breathing treatments, vest clearance system. Perform suctioning before, during and after as required to maintain patent airway and clear mobilized secretions. * However, review of the SN notes from 1/19/25 to 2/6/25, showed the SN did not administer the cough assist after Patient 7 received levosalbutamol (breathing treatment medication) on the following days as per the POC: - 1/19/25 at 1700 hours - 1/20/25 at 1730 and 2130 hours - 1/21/25 at 1730 and 2130 hours On 2/18/25 at 0845 hours, an interview and concurrent agency document review was conducted with the CEO/Administrator Designee. The CEO/Administrator Designee was informed and acknowledged the above finding. d. The POC, for the certification periods from 11/20/24 to 1/18/25 and 1/19/25 to 3/19/25, showed a physician’s order dated 5/24/24, to administer Patient 7 melatonin (sleep aid supplement) 3 mg via GT 3 tablets (for a total of 9 mg) daily at 2100 hours. Administer routinely at 2100 hours. May administer an additional PRN tablet by PCG request (for a total of 4 tablets - 12 mg). * Review of Patient 7's MAR showed to administer Patient 7 melatonin 9mg at 2100 routinely. However, the scheduled administration time for melatonin was for 2200 hours. In addition, there was no documented evidence melatonin was administered to Patient 7 on 11/20-11/22, 11/25-11/29, 12/2-12/6, 12/9-12/13, 12/16-12/20, 12/23, 12/25-12/27, 12/30/24, 1/1-1/3, 1/6-1/10, 1/13-1/17, 1/20-1/24, and 1/27-1/31/25. On 2/18/25 at 0854 hours, an interview and concurrent agency document review was conducted with the CEO/Administrator Designee. The CEO/Administrator Designee was informed and acknowledged the above finding. e. The POC, for the certification periods from 11/20/24 to 1/18/25 and 1/19/25 to 3/19/25, showed a physician’s order dated 5/24/24, to administer Patient 7 polyethylene glycol (stool softener medication) powder 17 grams /capful via GT twice daily to be added to hydration. Combine with 15mL water to dissolve, then add to hydration in enteral feeding bag twice daily at 1000 and 2200 hours. * However, review of Patient 7’s MAR, showed to administer Patient 7 polyethylene glycol (stool softener medication) powder 17 grams /capful via GT twice daily to be added to hydration. Combine with 15mL water to dissolve, then add to hydration in enteral feeding bag twice daily at 0900 and 1900 hours. In addition, Patient 7 was administered polyethylene glycol on 1/30-1/31/25 at 1910 hours and 2/1/25 at 1912 hours. There were no documented evidence Patient 7 was administered polyethylene glycol on 11/2024 to 1/29/25 for the routine 1900 hours scheduled administration. On 2/18/25 at 0859 hours, an interview and concurrent agency document review was conducted with the CEO/Administrator Designee. The CEO/Administrator Designee was informed and acknowledged the above finding. Findings: #. Clinical record review for Patient 1 was initiated on 2/6/25. The clinical record showed the SOC was 11/1/21. The patient was certified for home health services during the certification periods from 10/16/24 to 12/14/24 and 12/15/24 to 2/12/25. The POC, for the certification periods from 10/16/24 to 12/14/24 and 12/15/24 to 2/12/25, cited SN to monitor output in the colostomy hourly during shift and empty the pouch every two hours and PRN if 1/3 full or to expel excess gas. In addition, in the medication section of the POC, showed to administer Gamunex (immune globulin) 52.5 Grams (525 ml) infuse via pump over at least 10 hours and 57 minutes daily for two day every four weeks; diphenhydramine (antihistamine) 12.5 mg/5 ml 30 to 45 minutes prior to Gamulex infusion; and gentamicin (antibiotic) 40 mg/ml instill 50 ml of prepared solution into bladder daily and drain at next catheterization. However, the POC was not followed. For example: *Review of the SN note dated 10/27/24 at 1015 to 2130 hours, showed IVIG was administered at 1130 hours; however, there was no documented evidence diphenhydramine was administered as per the POC. *The SN note dated 12/15/24 at 0700 to 1900 hours, showed the SN had monitored the output in the colostomy at 1000, 1135, 1330, 1530, and 1800 hours instead of hourly as per the POC. In addition, Gamulex was administered on 1000 hours; however, there was no documented evidence diphenhydramine was administered as per the POC and there was no documented evidence Gamulex was administered daily for two days as per the POC. *The SN note dated 12/16/24 at 2100 hours to 12/17/24 at 0600 hours, showed the SN had emptied the pouch at 2130 and 0130 hours instead of every two hours as per the POC. *The SN note dated 12/17/24 at 0700 to 1700 hours, showed the SN had monitored the output in the colostomy at 0730, 0915, 1115, and 1330 hours instead of hourly as per the POC. *The SN note dated 1/12/25 at 0700 to 1900 hours, showed at 0800 hours, gentamicin 40 mg/ml 50 ml or prepared solution was instilled to the bladder; however, there was no documented evidence it was drained at the next catheterization at 1100 hours as per the POC. On 2/18/25 at 0830 hours, the CEO/Administrator Designee was informed and acknowledged the findings. On 2/18/25 at 1100 hours, the Administrator/DPCS stated the Gamulex was administered on 12/14/24; however, she acknowledged there was no documented evidence it was administered. #. Closed clinical record review for Patient 3 was initiated on 2/11/25. The clinical record showed the SOC was 7/7/24. The patient was certified for home health services during the certification periods from 7/7/24 to 9/4/24 and 9/5/24 to 11/3/24. The patient was discharged from the agency on 10/1/24. The POC, for the certification periods from 7/7/24 to 9/4/24 and 9/5/24 to 11/3/24, cited SN to perform shallow tracheal suctioning and document every four hours the number of times patient was suctioned since the last entry. SN to monitor pulse oximetry continuously and document oxygen saturation every four hours. In addition, in the medication section of the POC, showed to administer tobramycin (antibiotic) 300 mg/5 ml two times daily via nebulizer every other month during even months; and aztreonam (antibiotic) 75 mg/vial 1 vial three times daily every other month during odd months. However, the POC was not followed. For example: *Review of the MAR for the month of July 2024 showed tobramycin was administered from 7/7 to 7/18/24, instead of only during even months as per the POC. *The MAR for the month of September 2024 failed to show documented evidence aztreonam was administered on 9/1, 9/2, and 9/3/24 as per the POC. *Review of the SN note dated 7/7/24 at 0800 to 2100 hours, showed Patient 3 was on continuous oxygen pulse oximetry; however, the SN did not document the oxygen saturation every four hours as per the POC. *The SN note dated 7/8/24 at 0700 to 2100 hours, showed the SN had performed tracheal suctioning at 0700, 1000, 1500, and 2100 hours; however, the SN did not document the number of times Patient 3 was suctioned as per the POC. *The SN note dated 7/9/24 at 0700 to 2100 hours, showed the SN had performed tracheal suctioning at 0700, 1000, and 1600 hours; however, the SN did not document the number of times Patient 3 was suctioned as per the POC. On 2/18/25 at 0830 hours, the CEO/Administrator Designee was informed and acknowledged the findings. #. Closed clinical record review for Patient 4 was initiated on 2/12/25. The clinical record showed the SOC was "11/29/23." The patient was certified for home health services during the certification periods from 11/30/23 to 1/28/24 and 1/29/24 to 3/28/24. The patient was discharged from the agency on 3/15/24. The POC, for the certification periods from 11/30/23 to 1/28/24 and 1/29/24 to 3/28/24, SN visits 660 hours per 30 days for 60 days. However, the POC was not followed. For example: *Review of the SN notes from 12/1 to 12/31/23, showed SN visits had a total of 496 hours instead of 660 hours as per the POC. *Review of the SN notes from 1/1 to 1/31/24, showed SN visits had a total of 480 hours instead of 660 hours as per the POC. *Review of the SN notes from 2/1 to 3/1/24, showed SN visits had a total of 411 hours instead of 660 hours as per the POC. On 2/18/25 at 0830 hours, the CEO/Administrator Designee 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 skilled professionals prepared accurate clinical notes for five of seven sampled patients (Patients 1, 2, 3, 5, and 6 ). This failure had the potential for substandard healthcare outcomes to these patients. 3. Review of Patient 6's clinical record was initiated on 2/12/25. The clinical record showed the SOC was 3/25/22. The patient was certified for home health services during the certification periods from 10/20/24 to 12/18/24 and 12/19/24 to 2/16/25. The POC, for the certification period from 10/20/24 to 12/18 24, showed to apply AFOs when up in chair two times day for 30 minutes, as tolerated. The POC showed for SN to document time AFOs applied, time removed and skin condition. The SN note dated 10/23/24 (0800 hours to 1400 hours), showed at 0800 hours the AFOs were applied when up in chair two times day for 30 minutes, as tolerated. Documentation showed “Additional Details: 3 hours.” * However, the “Additional Details: 3 hours” was not clear as to what it meant. The MAR Addendum and PRN Effectiveness dated 01/06/25, showed sennosides (laxative) was administered at 0830 hours. Documentation showed at 1357 hours, the effectiveness/reaction showed will continue to monitor. * However, there was no documented evidence to show if the medication was effective or not. On 2/18/25 at 0852 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. She stated the “Additional Details: 3 hours” was the amount of time the patient was in the wheelchair. 4. Review of Patient 5's clinical record was initiated on 2/12/25. The clinical record showed the SOC was 3/10/23. The patient was certified for home health services during the certification periods from 10/30/24 to 12/28/24 and to 12/29/24 to 2/26/25. The MAR Addendum and PRN Effectiveness dated 01/17/25, showed levalbuterol (bronchodilator) was administered at 2100 hours and Mucinex (expectorant) 2210 hours. Documentation showed at "215" and 2218 hours, the effectiveness/reaction showed “TBD”. * However, there was no documented evidence to show if the medications were effective or not. On 2/18/25 at 0815 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. 5. Review of Patient 2's clinical record was initiated on 2/6/25. The clinical record showed the SOC was 11/2/23. The patient was certified for home health services during the certification period from 12/29/24 to 2/26/25. The OASIS E SOC/ROC assessment dated 11/5/23, showed the RN performed the initial comprehensive assessment. Documentation showed the patient had diffuse blisters on bilateral lower extremities. Documentation showed the onset date was 11/10/23. On 2/18/25 at 0932 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She stated the onset date of the diffuse blisters on bilateral lower extremities in the assessment was a typographical error. The POC, for the certification period from 12/29/24 to 2/26/25, showed SN to reposition patient every time requested during daytime hours and while in bed every two hours and PRN for comfort of sign/symptoms redness/pressure. The SN note dated 12/31/24 (1800 hours to 2200 hours) showed at 1810 hours, the patient was repositioned. * However, there was no documented evidence after 1810 hours, the patient was repositioned Q two hours while in bed or if the patient was not in bed. On 2/18/25 at 932 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. Findings: #. Clinical record review for Patient 1 was initiated on 2/6/25. The clinical record showed the SOC was 11/1/21. The patient was certified for home health services during the certification periods from 10/16/24 to 12/14/24 and 12/15/24 to 2/12/25. Review of the supplemental physician's order obtained by the RN dated 12/26/24, showed SN had provided a total of 146.4 hours during the period from 11/12 to 12/11/24. *However, review of the SN notes from 11/12 to 12/11/24, showed SN had provided a total of 225.25 hours which was inconsistent with the above physician's order. On 2/18/25 at 0830 hours, the CEO/Administrator Designee was informed and acknowledged the finding. #. Closed clinical record review for Patient 3 was initiated on 2/11/25. The clinical record showed the SOC was 7/7/24. The patient was certified for home health services during the certification periods from 7/7/24 to 9/4/24 and 9/5/24 to 11/3/24. The patient was discharged from the agency on 10/1/24. Review of the SN assessment dated 7/7/24, showed Patient 3's trach was last changed on 7/31/24. On 2/18/25 at 0830 hours, the CEO/Administrator Designee was informed and of the finding. The CEO/Administrator Designee stated it was a "typo" error and the date Patient 3's trach was changed must have been 7/3/24.

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 SN to ensure quality of care and services were provided for five of seven sampled patients (Patients 1, 3, 4, 5, and 6 ). This failure had the potential for poor health outcomes to these patients. Findings: #. Clinical record review for Patient 1 was initiated on 2/6/24. The clinical record showed the SOC was 11/1/21. The patient was certified for home health services during the certification periods from 10/16/24 to 12/14/24 and 12/15/24 to 2/12/25. Review of the clinical record for Patient 1 showed the SN did not provide services in accordance with the POC for this patient. Cross reference to G710, example ##. The RN supervisory notes dated 11/20, 12/10/24, and 1/14/25, showed the RN had conducted supervisory visits; however, the RN failed to identify the SN did not provide services in accordance with the POC. #. Closed clinical record review for Patient 3 was initiated on 2/11/24. The clinical record showed the SOC was 7/7/24. The patient was certified for home health services during the certification periods from 7/7/24 to 9/4/24 and 9/5/24 to 11/3/24. The patient was discharged from the agency on 10/1/24. Review of the clinical record for Patient 3 showed the SN did not provide services in accordance with the POC for this patient. Cross reference to G710, example ##. The RN supervisory notes dated 8/30 and 9/2/24, showed the RN had conducted supervisory visits; however, the RN failed to identify the SN did not provide services in accordance with the POC. #. Closed clinical record review for Patient 4 was initiated on 2/12/24. The clinical record showed the SOC was "11/29/23." The patient was certified for home health services during the certification periods from 11/30/23 to 1/28/24 and 1/29/24 to 3/28/24. The patient was discharged from the agency on 3/15/24. Review of the clinical record for Patient 1 showed the SN did not provide services in accordance with the POC for this patient. Cross reference to G710, example ##. The RN supervisory notes dated 1/26, 2/1, and 2/2724, showed the RN had conducted supervisory visits; however, the RN failed to identify the SN did not provide services in accordance with the POC. On 2/18/25 at 0830 hours, the CEO/Administrator Designee was informed and acknowledged the findings. 4. Review of Patient 6's clinical record was initiated on 2/12/25. The clinical record showed the SOC was 3/25/22. The patient was certified for home health services during the certification periods from 10/20/24 to 12/18/24 to 12/19/24 to 2/16/25. Review of the clinical record for Patient 6 showed the LVN did not provide services in accordance with the POC for this patient. Cross reference to G710, example --. The Comprehensive Assessment & Supervisory Report |dated 11/15/24, showed the RN conducted a supervisory visit. * However, the RN failed to identify the LVN did not provide services in accordance with the POC. On 2/18/25 at 0852 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. 5. Review of Patient 5's clinical record was initiated on 2/12/25. The clinical record showed the SOC was 3/10/23. The patient was certified for home health services during the certification periods from 10/30/24 to 12/28/24 and to 12/29/24 to 2/26/25. Review of the clinical record for Patient 5 showed the LVN did not provide services in accordance with the POC for this patient. Cross reference to G710, example --. The Supervisory Visit and Comprehensive Assessment dated 11/5/25, showed the RN had conducted a supervisory visit. * However, the RN failed to identify the LVN did not provide services in accordance with the POC. On 2/18/25 at 0815 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. Findings: 1. Clinical record review for Patient 1 was initiated on 2/6/24. The clinical record showed the SOC was 11/1/21. The patient was certified for home health services during the certification periods from 10/16/24 to 12/14/24 and 12/15/24 to 2/12/25. Review of the clinical record for Patient 1 showed the SN did not provide services in accordance with the POC for this patient. Cross reference to G710, example #1. The RN supervisory notes dated 11/20, 12/10/24, and 1/14/25, showed the RN had conducted supervisory visits; however, the RN failed to identify the SN did not provide services in accordance with the POC. 2. Closed clinical record review for Patient 3 was initiated on 2/11/24. The clinical record showed the SOC was 7/7/24. The patient was certified for home health services during the certification periods from 7/7/24 to 9/4/24 and 9/5/24 to 11/3/24. The patient was discharged from the agency on 10/1/24. Review of the clinical record for Patient 3 showed the SN did not provide services in accordance with the POC for this patient. Cross reference to G710, example #2. The RN supervisory notes dated 8/30 and 9/2/24, showed the RN had conducted supervisory visits; however, the RN failed to identify the SN did not provide services in accordance with the POC. 3. Closed clinical record review for Patient 4 was initiated on 2/12/24. The clinical record showed the SOC was "11/29/23." The patient was certified for home health services during the certification periods from 11/30/23 to 1/28/24 and 1/29/24 to 3/28/24. The patient was discharged from the agency on 3/15/24. Review of the clinical record for Patient 1 showed the SN did not provide services in accordance with the POC for this patient. Cross reference to G710, example #3. The RN supervisory notes dated 1/26, 2/1, and 2/2724, showed the RN had conducted supervisory visits; however, the RN failed to identify the SN did not provide services in accordance with the POC. On 2/18/25 at 0830 hours, the CEO/Administrator Designee was informed and acknowledged the findings. 4. Review of Patient 6's clinical record was initiated on 2/12/25. The clinical record showed the SOC was 3/25/22. The patient was certified for home health services during the certification periods from 10/20/24 to 12/18/24 to 12/19/24 to 2/16/25. Review of the clinical record for Patient 6 showed the LVN did not provide services in accordance with the POC for this patient. Cross reference to G710, example #5. The Comprehensive Assessment & Supervisory Report |dated 11/15/24, showed the RN conducted a supervisory visit. * However, the RN failed to identify the LVN did not provide services in accordance with the POC. On 2/18/25 at 0852 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. 5. Review of Patient 5's clinical record was initiated on 2/12/25. The clinical record showed the SOC was 3/10/23. The patient was certified for home health services during the certification periods from 10/30/24 to 12/28/24 and to 12/29/24 to 2/26/25. Review of the clinical record for Patient 5 showed the LVN did not provide services in accordance with the POC for this patient. Cross reference to G710, example #6. The Supervisory Visit and Comprehensive Assessment dated 11/5/24, showed the RN had conducted a supervisory visit. * However, the RN failed to identify the LVN did not provide services in accordance with the POC. On 2/18/25 at 0815 hours, an interview and concurrent clinical record review was conducted with the Administrator/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 record review, the agency’s Administrator failed to be responsible for the day-to-day operations related to ensuring LVN 1's pre-employment physical health examination was completed timely before the start of employment. This failure had the potential for not providing quality of care and services to the patients receiving services at the HHA. Findings: Review of the agency’s Job Description for Administrator revised 10/2018 showed the Administrator's responsibilities included participation in ensuring 100% compliance with all Federal and State regulations, reimbursement criteria as well as agency policies and procedures at all times. According to Title 22 Section 74723 (Employee’s Health Examination and Health Record), showed the following: (b) A written health assessment of each employee who had direct patient contact shall: (1) Be required as a prerequisite of employment. (2) Be performed within six months prior to employment or within 15 days of assuming employment with the agency. Review of LVN 1’s employee file showed a hired date of 5/16/24. Review of LVN 1’s pre-employment physician’s history and physical examination showed a completion date of 6/1/24, 16 days before assuming employment with the agency. On 2/18/25 at 0910 hours, an interview and concurrent agency document review was conducted with the CEO/Administrator Designee. The CEO/Administrator Designee was informed and acknowledged the above finding.

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 the agency failed to ensure the agency’s P&Ps were implemented as evidenced by: There was no address listed in the written complaint filings for nonsampled patients (Patients A and B) as per the agency’s P&P. The P&P related to wound assessment and documentation were not followed for one of seven sampled patients (Patient 2) These failures created the risk of not providing quality of care and services to the patients receiving services from the HHA. The agency’s P&P titled Wound assessment and Documentation undated, showed to document the following on the visit report: - The treatment and condition of the wound (each visit) - Appearance of the wound bed (black, yellow, green, tan, red, or pink) - Wound measurements (at least weekly), including the length, depth, and width of the wound in centimeters - Depth and location of undermining in centimeters - Inflammation or erythema of the skin around the wound - Color, odor, and estimated amount of drainage - Stage the wound weekly, and compare the progress with the goals of therapy - Any patient/caregiver instructions on wound care and response to teaching, including ability to change dressings and manage the wound at home - Physician notification, if applicable - Standard Precautions - Other pertinent findings Review of Patient 2's clinical record was initiated on 2/6/25. The clinical record showed the SOC was 11/2/23. The patient was certified for home health services during the certification period from 12/29/24 to 2/26/25. Documentation showed inconsistencies with the wound assessment, treatment, and documentation. For example: The OASIS E Recertification assessment dated 12/26/24 (1000 to 1100 hours), showed the patient had a left buttock skin tear. Documentation showed the size was 1cm (length) x 0.5cm (width) x 0.25cm (depth). Documentation showed the treatment was Duoderm. The physician’s order dated 12/26/24, showed to cleanse small left bittock skin tear with normal saline, pat dry, apply a Mepilex Border flex (wound dressing) self-adherent soft silicone foam dressing Q two to three days and PRN for soiling/dislodgement until healed. The SN note dated 12/26/24 (1800 hours to 2200 hours), showed the patient’s skin condition was dry, intact, and clean. The SN note dated 12/27/24 (0600 hours to 1000 hours), showed the patient’s skin condition included rash and pressure injury. The SN note dated 12/27/24 (1800 hours to 2200 hours),12/28/24 (0600 to 2200 hours), and 12/28/24 (1800 hours to 2200 Hours), showed the patient’s skin condition was dry, intact, and clean. The POC, for the certification period from 12/29/24 to 2/26/25, showed the following information The SN note dated 12/29/24 (0600 hours to 1000 hours), showed the patient’s skin condition was dry, intact, and clean. The SN note dated 12/29/24 (1800 hours to 2200 hours) showed the patient’s skin condition was dry, intact, and clean. The SN note dated 12/30/24 (0600 hours to 1000 hours), showed the patient’s skin condition included rash, pressure Injury, and excessive dryness. The SN note dated 12/30/24 (1800 hours to 2200 hours), showed patient’s skin condition was dry, intact, and clean. The SN note dated 12/31/24 (0600 hours to 1000 hours), showed the patient’s skin condition included rash, pressure Injury, and excessive dryness. * However, there was no documented evidence of what the status of the left buttock skin tear was. There was no documented evidence if the left buttock skin tear was healed. Some of the SN assessments included pressure injury which was inconsistent on the recertification assessment dated 12/26/24. There was no documented evidence treatment was performed on the left buttock skin tear. On 2/18/25 at 0932 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the findings. Findings: # The agency’s P&P titled Grievance and Section 504 Complaints Procedure for Employees or Patients dated 10/20/20, showed a formal complaint must be in writing, containing the name and address of the person filing it (“the grievant”). The complaint must state the problem, or any action alleged to be discriminatory, and the remedy or relief sought by the grievant. Informal complaints may be submitted by phone or in person. Review of the agency’s complaint log (undated) showed there was a complaint filed regarding Patients A and B. a. Review of a Grievance Detail form regarding Patient A dated 10/31/24, showed the grievant ‘s name was provided. However, the grievant’s address was not included in the form as per the agency’s P&P. b. Review of a Grievance Detail form regarding Patient B dated 8/1/23, showed the grievant ‘s name was provided. However, the grievant’s address was not included in the form as per the agency’s P&P. On 2/18/25 at 0940 hours, an interview and concurrent agency document review was conducted with the CEO/Administrator Designee. The CEO/Administrator Designee was informed and acknowledged the above findings.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to maintain accurate and complete clinical records for two of seven sampled patients (Patients 1 and 4). This failure had the potential for substandard quality of care due to incomplete or inaccurate clinical records. Findings: 1. Clinical record review for Patient 1 was initiated on 2/6/25. The clinical record showed the SOC was 11/1/21. The patient was certified for home health services during the certification periods from 10/16/24 to 12/14/24 and 12/15/24 to 2/12/25. The POC, for the certification periods from 10/16/24 to 12/14/24 and 12/15/24 to 2/12/25, cited SN to perform clean intermittent catheterization at 1200 and 1500 hours. The medication section in the POC showed to irrigate bladder with sodium chloride 0.9% 200 ml daily during catheterization at 1300 hours. However, there was no ordered catheterization at 1300 hours. On 2/18/25 at 0830 hours, the CEO/Administrator Designee was informed and acknowledged the finding. 2. Closed clinical record review for Patient 4 was initiated on 2/12/25. The clinical record showed the SOC was "11/29/23." The patient was certified for home health services during the certification periods from 11/30/23 to 1/28/24 and 1/29/24 to 3/28/24. The patient was discharged from the agency on 3/15/24. The POC, for the certification periods from 11/30/23 to 1/28/24 and 1/29/24 to 3/28/24, cited SN visits 660 hours per 30 days for 60 days. However, the POC did not include all the treatments and medications necessary to meet the patient's needs. For example: Review of the SN notes dated 12/1, 12/2, and 12/3/23 at 0700 to 2300 hours, showed the SN performed shallow tracheal suctioning, tracheostomy care two times daily, and omphalocele dressing (nonadherent dressings, and silver-impregnated dressing) changes at 2000 hours as follows: to remove previous dressing, cleanse with Vashe (antiseptic) wound cleanser, apply ordered topical cream, cover with Vaseline gauge then, stretch gauge. However, the POC did not include these treatments. Review of the MAR for the month of December 2024 showed Patient 4 was administered lactulose (laxative) on 12/4, 12/7, and 12/9/23; and Glycerin (laxative) suppository on 12/11/23. However, the POC did not include these PRN medications. On 2/8/25 at 0830 hours, the CEO/Administrator Designee was informed of the finding. The CEO/Administrator Designee stated it was missed and acknowledged the finding.

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 39210, HFEN; 31929, HFEN; and 39539, HFEN. The survey team entered the HHA on 4/5/22 at 0730 hours. The agency was found to be in compliance with the HHA Emergency Preparedness requirements.

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 39210, HFEN; 31929, HFEN; and 39539, HFEN. The survey team entered the HHA on 4/5/22 at 0730 hours. The survey team conducted 3 home visits and reviewed 5 active and 2 closed clinical records. Glossary: BP: blood pressure CEO: Chief Executive Officer DPCS: Director of Patient Care Services F: Fahrenheit G-tube: gastrostomy tube (a small tube placed through the abdominal wall into the stomach, used to provide feeding formula and/or administer medications) HHA: Home Health Agency J-tube: jejunostomy tube (a soft, plastic tube placed through the skin of the abdomen into the midsection of the small intestine) LVN: Licensed Vocational Nurse mg: milligram(s) ml: milliliter(s) mmHg: millimeter(s) of mercury OASIS: Outcome and Assessment Information Set P&P: Policy and Procedure POC: Plan of Care PRN: As Needed Q: Every QAPI: Quality Assurance and Performance Improvement (process used to ensure services are meeting quality standards) RN: Registered Nurse SN: Skilled Nursing/Nurse SOC: Start of Care UTI : urinary tract infection URI: upper respiratory infection

Transmittal of OASIS data CFR(s): 484.45(c) Standard: Transmittal of OASIS data. An HHA must- This STANDARD is not met as evidenced by: Based on interview and clinical record review, the facility failed to ensure the OASIS data were transmitted for four of seven patients (Patients 2, 3, 6, and 7), creating the risk of not reporting and coordinating patient care assessments for patients receiving care and services from the HHA. Findings: An entrance conference was conducted on 4/5/21 at 0900 hours, with the CEO and Administrator/ DPCS. The CEO stated the HHA had not been transmitting OASIS data because of the patient/family's refusal to transmit OASIS information. 1. Review of Patient 7's clinical record was initiated on 4/7/22. The clinical record showed the SOC was 12/27/17. The patient was certified for home health services during the certification period from 2/4/22 to 4/4/22. Review of the Patient's Rights showed a section regarding release of information. Documentation showed, "I further authorize the HHA to release, or receive from hospitals, health care institutions, physicians, accreditation, regulatory or other agencies involved in my care, all medical records and information pertinent to my care," and was signed on 12/27/17. Review of an electronic email dated 11/21/18, showed the family member had received the Patient's Rights and addendum to Patient's Rights document. The information which was on the Patient's Rights document dated 12/27/17, had the same information regarding the release of information. Review of an untitled document showed the patient's name and "OASIS-no transmit." * However, there was no documented evidence showing a discussion of the patient/PCG's refusal to transmit OASIS information in the clinical record. 2. Review of Patient 3’s closed clinical record was initiated on 4/7/22. The closed clinical record showed the SOC was 12/9/18. The patient was certified for home health services during the certification periods from 5/27/21 to 7/25/21, and 7/26/21 to 9/23/21. Review of the Patient's Rights showed a section regarding release of information. Documentation showed "I further authorize the HHA to release, or receive from hospitals, health care institutions, physicians, accreditation, regulatory or other agencies involved in my care, all medical records and information pertinent to my care," and was signed on 12/9/18. Review of an untitled document showed the patient's name, "OASIS-no transmission." * However, there was no documented evidence showing a discussion of the patient/PCG's refusal to transmit OASIS information in the clinical record. On 4/12/22 at 1350 hours, the CEO and Administrator/DPCS was asked for documentation on the patient/family refusal to transmit OASIS data. The Administrator/DPCS stated the OASIS information including transmittal was explained to the over age 18 patients/families at the SOC. The Administrator/DPCS stated for the patients who were admitted before age 18 and will be at the age of 18, the OASIS information including transmittal was explained to the patients/families during a supervisory visit before the first OASIS would be performed. The Administrator/DPCS stated based on the conversation with the patient/family, the HHA would create an OASIS file in the patient's computer folder and label as to transmit or not to transmit. On 4/13/22 at 1000 hours, an interview a was conducted with the CEO and Administrator/DPCS. They were informed of the finding. 3. Review of Patient 2’s clinical record was initiated on 4/5/22. The clinical record showed the SOC was 5/19/16. The clinical record showed the patient received home health services during the certification periods from 12/20/21 to 2/17/22, and 2/18/22 to 4/18/22. Review of the Patient Rights dated 8/28/18, showed the details regarding the patient’s release of information. The document showed "I further authorize the HHA to release, or receive from hospitals, health care institutions, physicians, accreditation, regulatory or other agencies involved in my care, all medical records and information pertinent to my care", and was signed by the patient or representative on 8/28/18. Review of the untitled document provided by the HHA showed the patient's name and a document folder titled “OASIS-no transmission.” Further review of Patient 2’s clinical record showed there was no documented evidence the patient’s OASIS information was transmitted. There was also no documented evidence showing the patient’s refusal to release the OASIS information. 4. Review of Patient 6’s clinical record was initiated on 4/5/22. The clinical record showed the SOC was 11/3/20. The patient was certified for home health services during the certification periods from 12/28/21 to 2/25/22, and 2/26/22 to 4/26/22. Review of the Patient Rights dated 11/3/20, showed the details regarding the patient’s release of information. The document showed, "I further authorize the HHA to release, or receive from hospitals, health care institutions, physicians, accreditation, regulatory or other agencies involved in my care, all medical records and information pertinent to my care," and was signed by the patient’s representative on 11/3/20. Review of the untitled document provided by the HHA showed the patient's name and a document folder titled “OASIS-no transmit.” Further review of Patient 6’s clinical record showed there was no documented evidence the patient’s OASIS information was transmitted. There was also no documented evidence showing the patient’s refusal to release the OASIS information.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on interview and clinical record review, the agency failed to ensure the recertification assessments were completed within the last five days of the certification period for two of seven sampled patients (Patients 1 and 5), creating the risk of not providing the necessary care and services to these patients. Findings: 1. Review of Patient 5’s clinical record was initiated on 4/6/22. The clinical record showed the SOC was 9/4/19. The patient was certified for home health services during the certification period from 1/14/22 to 3/14/22 and 3/15/22 to 5/13/22. Review of Patient 5’s Comprehensive Assessment and Supervisory Visit Reports showed the comprehensive assessments were conducted on 12/29/20, 1/21, 2/25, and 3/25/22. However, further review of the patient's clinical record failed show documented evidence the recertification assessments were completed within the last five days of the certification period. On 4/13/22 at 0815 hours, an interview and concurrent clinical record review was conducted with LVN 1. LVN 1 was informed and acknowledged the finding. 2. Review of Patient 1's clinical record was initiated on 4/6/22. The clinical record showed the SOC was 12/11/08. The patient was certified for home health services during the certification period from 12/02/21 to 1/30/22, and 1/31 to 3/31/22. Review of Patient 5’s Comprehensive Assessment and Supervisory Visit Reports showed the comprehensive assessments were conducted on 11/11, 12/27/21, and 1/28/22, However, further review of the patient's clinical record failed show documented evidence the recertification assessments were completed within the last five days of the certification period. On 4/13/22 at 0915 hours, an interview and concurrent clinical record review was conducted with the CEO. The CEO 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 clinical record review, the facility failed to ensure the POCs included specific information related to medication administration for two of seven sampled patients (Patients 3 and 7), creating the risk of not addressing the care needs for these patients. Findings: 1. Review of Patient 7's clinical record was initiated on 4/7/22. The clinical record showed the SOC was 12/27/17. The patient was certified for home health services during the certification period from 2/4/22 to 4/4/22. The POC, for the certification period from 2/4/22 to 4/4/22, showed the following medications: Tylenol Extra Strength (analgesic) 500 mg Q six hours via G-tube PRN for pain, do not exceed four tablets for 24 hours; and ibuprofen (nonsteroidal anti-inflammatory drug) 260 mg Q six hours via G-tube PRN for pain. * However, the POC did not include the specific instructions as to which medication was to be administered first for pain On 4/13/22 at 0900 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. The Administrator/DPCS was informed and acknowledged the finding. 2. Review of Patient 3’s closed clinical record was initiated on 4/7/22. The closed clinical record showed the SOC was 12/9/18. The patient was certified for home health services during the certification periods from 5/27/21 to 7/25/21, and 7/26/21 to 9/23/21 The POC, for the certification periods from and 5/27/21 to 7/25/21 and 7/26/21 to 9/23/21, included the following medications: ibuprofen 400 mg Q six hours via G-tube PRN for mild to severe pain, Tylenol 500 mg Q four hours via G-tube PRN for pain/discomfort, and Tylenol with Codeine (opioid analgesic) “120-12/5 ml” 8.3 ml Q six hours PRN for severe pain. * However, the POC did not include the specific instruction as to when/what patient's pain condition/intensity for Tylenol 500 mg Q four hours via G-tube PRN to be administered. On 4/13/22 at 0830 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. The Administrator/DPCS was informed and acknowledged the finding.

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 interview and clinical record review, the agency failed to ensure the agency had revised the POC for one of seven sampled patients (Patient 4), creating the risk of a substandard healthcare outcome to this patient. Findings: Review of Patient 4’s closed clinical record was initiated on 4/7/22. The closed clinical record showed the SOC was 9/2/17. The patient was certified for home health services during the certification periods from 10/11/21 to 12/9/21, and 12/10/21 to 2/7/22. a. The POC, for the certification periods from 10/11/21 to 12/9/21 and 12/10/21 to 2/7/22, showed the patient may have up to 8 ounce of free water for the remaining five hours daily at a rate of 30 ml/hour via pump as tolerated. The Treatment Record from 10/10 to 10/31/21, 11/1to 11/27/21, 12/12 to 12/18/21 and 1/16 to 1/18/21, showed the free water daily up to eight ounces via J-tube at 50 ml/hour as tolerated were administered from 1600 to 0800 hours. However, the rate and duration to provide the free water was not consistent in the POC and Treatment Record. On 4/13/22 at 0930 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She stated the correct information related to the rate and duration was in the patient’s treatment record. * The HHA failed to revise the patient’s POC. b. The physician’s order dated 12/9/21, showed Peptamen Junior (nutritional formula) at 60 ml with 35 ml of water to run at a rate of 95 ml/hour continuously for 19 hours daily over pump via J-tube The POC, for the certification period from 12/10/21 to 2/7/22, showed Peptamen Junior at 68 ml/hour plus 20 ml of water to run at a rate of 88 ml/hour continuously for 19 hours over pump via J-tube. However, the MAR dated 12/12 to 12/18/21, showed Peptamen Junior at 60 ml with 35 ml of water to run at a rate of 95 ml/hour continuously for 19 hours daily over pump via J-tube On 4/13/22 at 0930 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She stated the POC should have been amended to show Peptamen Junior at 60 ml with 35 ml of water to run at a rate of 95 ml/hour continuously for 19 hours daily over pump via J-tube. The Administrator/DPCS was informed and acknowledged the finding.

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 regarding the patients' care needs for two of seven sampled patients (Patients 2 and 5). This failure created the risk of not providing the necessary care and services to these patients. Findings: 1. Review of the agency’s P&P titled Physician Relations/Medical Consultation/Physician Notification dated 10/2018, showed the staff guidelines for physician notification. The P&P showed when the patient measurements are outside the ordered physician parameters or are either significantly higher or lower than the patient’s normal baseline measurement including but not limited to blood pressure, temperature, respiration, pulse, blood sugar, edema, urinary output, and weight loss or gain, the physician must be notified immediately. Review of Patient 2’s clinical record showed the SOC was 5/19/16. The clinical record showed the patient received home health services during the certification period from 2/18/22 to 4/18/22. The POC, for the certification period from 2/18/22 to 4/18/22, showed to perform skilled observation and assessment of all systems, including temperature, pulse, respiratory rate, and pain every shift and as needed for complications; and only perform blood pressure assessment as needed for signs and symptoms of high or low blood pressure. Review of the RN/LVN Shift Clinical Notes showed the following: - On 3/10/22, the patient’s blood pressure was 91/60 mmHg. - On 3/18/22, the patient’s blood pressure was 96/62 mmHg. - On 4/1/22, the patient’s blood pressure was 96/66 mmHg. - On 4/2/22, the patient’s blood pressure was 98/64 mmHg. Review of the RN/LVN Shift Clinical Notes for the dates listed above showed the SN worked for eight hours shift, from 1500 to 2300 hours; however, there was no documented evidence showing the SN rechecked the patient’s blood pressure during the eight-hour shift. In addition, there was no documented evidence showing the SN notified the physician of Patient 2’s blood pressure measurements. On 4/13/22 at 0831 hours, an interview and concurrent clinical record review was conducted with the CEO. The CEO was informed and acknowledged the findings. 2. Review of Patient 5’s clinical record was initiated on 4/6/22. The clinical record showed the SOC was 9/4/19. The patient was certified for home health services during the certification period from 1/14/22 to 3/14/22, and 3/15/22 to 5/13/22. The POC, for the certification period 3/15/22 to 5/13/22, showed the RN/ LVN duties included skilled observation and assessment of all systems, including temperature, pulse, respirations every shift and as needed for complications. Review of the RN/ LVN Shift clinical notes showed the following: - On 2/25/22, Patient 5’s heart rate was 102 beats per minute. - On 2/15/22, Patient 5’s temperature was 99.0 degrees F and heart rate was 92 beats per minute. - On 2/14/22 ,Patient 5’s heart rate was 102 beats per minute. - On 2/8/22, Patient 5’s temperature was 99.0 degrees F and heart rate was 92 bears per minute. - On 2/5/22, Patient 5’s temperature was 99.0 degrees F and heart rate was 102 beats per minute. - On 2/4/22, Patient 5’s heart rate was 102 beats per minute; - On 2/1/22, Patient 5’s temperature was 99.0 degrees F. - On 1/31/22, Patient 5’s temperature was 99.3 degrees F and heart rate was 103 beats per minute. Further review of Patient 5’s clinical record failed to show documentation Patient 5’s heart rate or temperature was rechecked, or notified the physician of the temperature or heart rate measurements. On 4/13/22 at 0832 hours, a concurrent interview and clinical record review was conducted with LVN 1. LVN 1 was informed and acknowledged the finding.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview, and clinical record review, the agency failed to ensure infection control practices were implemented for two of seven sampled patients (Patients 6 and 7). This posed the risk for the spread of infectious organisms. Findings: 1. According to the CDC, adherence to infection prevention and control practices is essential in providing safe and high quality are across all settings where healthcare is delivered. The core practices included ensuring proper selection and use of PPE based on the nature of the patient interaction and potential for exposure to blood, body fluids, and/or infectious materials: wear gloves when it can be reasonably anticipated that contact with blood or other potentially infectious materials, mucous membranes, non-intact skin, potentially contaminated skin or contaminated equipment occur. Review of Patient 7's clinical record was initiated on 4/7/22. The clinical record showed the SOC was 12/27/17. The patient was certified for home health services during the certification period from 2/4/22 to 4/4/22 A joint home visit with LVN 3 was conducted on 4/7/22 at 1000 hours, to Patient 7's home. LVN 3 was observed performing medication administration via G-tube to Patient 7. LVN 1 washed her hands. LVN 3 connected the syringe to the patient’s G-tube. LVN 3 administered the patient's medications via G-tube. * However, LVN 3 did not wear gloves when G-tube was attached to the syringe and administered the medications via G-tube. On 4/13/22 at 0900 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. The Administrator/DPCS was informed and acknowledged the finding. 2. Review of the agency’s P&P titled Infection Prevention and Control dated 1/2019, showed the staff strategies from preventing and controlling infection transmission. The staff will be responsible for infection prevention and control activities by maintaining aseptic technique and when indicated sterile technique, and maintaining sterility and cleanliness of equipment and supplies. Review of Patient 6’s clinical record was initiated on 4/5/22. The clinical record showed the SOC was 11/3/20. The patient was certified for home health services during the certification period from 2/26/22 to 4/26/22. On 4/6/22 at 0900 hours, a joint home visit with LVN 2 was conducted to Patient 6’s home. LVN 2 was observed performing medication administration via G-tube to Patient 6. Prior to administering the medication, LVN 2 sanitized her hands and donned a pair of clean gloves. LVN 2 took the medication syringe with the exposed tip and placed it on top of the dresser. LVN 2 did not sanitize the top of the dresser nor placed a clean material to ensure the working surface was clean. LVN 2 then proceeded to use the tip of the medication syringe to mix the medication and water in the medicine cup. After preparing the medication, LVN 2 placed the medication syringe directly on top of Patient 6’s bed. The tip of the syringe was observed touching the pillow. LVN 2 then opened one of the G-tube ports and inserted the same medication syringe to check for the residual. After checking the residual, LVN 2 proceeded to administer the medication using the same medication syringe. On 4/6/22 at 1000 hours, an interview was conducted with LVN 2. LVN 2 was informed and acknowledged the findings.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to implement and maintain the infection control program which included surveillance, identification, prevention, control, and investigation of infections. This failure had the potential to result in the transmission of infection to the staff, caregivers, and the vulnerable population of patients in their homes. Findings: Review of the agency’s P&P titled Infection Prevention and Control dated 1/2019 showed the staff strategies for preventing and controlling infection transmission. The staff will be responsible for infection prevention and control activities by conducting infection surveillance, identification, and reporting activities. All infection control data will be reported and addressed by the QAPI Committee. On 4/12/22 at 0918 hours, an interview and concurrent record review was conducted with the Administrator/DPCS and CEO. Both were asked how the infection control program was implemented in the agency. The Administrator/DPCS stated there were several ways in which she received information about the patient infections. The patient infections were usually initially identified by the nurse, physician, or family/caregiver, then reported to the Administrator/DPCS. The data was collected, analyzed, and discussed quarterly by both the Administrator/DPCS and CEO. Each data would then be presented and discussed during the QAPI meeting which met at a yearly minimum. The agency’s latest QAPI meetings were conducted on 9/15/20 and 12/28/21. Review of the QAPI Meeting Minutes dated 9/15/20, showed the description of the patient/employee infection report findings for the first quarter of 2020. The meeting minutes showed there were two UTIs, three URIs, two “other” infections, and four prophylactic antibiotic use identified; however, review of the agency’s first quarter data aggregation for 2020 showed there were five UTIs, seven URIs, and six other miscellaneous types of infections identified by the agency which was inconsistent with the data that was presented during the QAPI meeting. Review of the QAPI Meeting Minutes dated 12/28/21, showed the QAPI meeting agenda included the patient/employee infections; however, there was no documented evidence showing what specific information was discussed and whether the last quarter of 2020 (October to December) was included in the meeting. Further review of the agency’s documents showed the agency collected the data of the patient specific infections quarterly for 2020 and 2021; however, there was no documented evidence showing the agency analyzed the data, investigated for possible causes of infection, tracked patterns and trends of infections, and implemented specific actions to minimize infections to improve care practices and control the transmission of infection among the staff, caregivers, and patients. On 4/13/22 at 0839 hours, an interview and concurrent document review was conducted with the CEO. The CEO 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, clinical record review, and agency’s P&P review, the agency failed to ensure the skilled professionals provided care and services in accordance with the POC for six of seven sampled patients (Patients 1, 2, 3, 4, 5, and 7). This failure created the risk of not providing appropriate, consistent, and quality care to the patients. Findings: 1. Review of Patient 7's clinical record was initiated on 4/7/22. The clinical record showed the SOC was 12/27/17. The patient was certified for home health services during the certification period from 2/4/22 to 4/4/22. The POC, for the certification period from 2/4/22 to 4/4/22, cited LVN visits 660 hours/30 days for 60 days and RN visits for management and evaluation of the plan of care two hours per month for two months. The POC also showed LVN duties included skilled observation and assessment of all systems, including temperature, pulse, respiration, BP, and pain Q four to twelve hours and PRN for complications. The SN note dated 3/25/22, showed the SN visits were conducted from 0700 to 1200 hours, 1200 to 1900 hours, and 2200 to 0700 hours. Documentation showed the patient’s BP at 0900 hours was 107/69 mm Hg. * However, there was no documented evidence the patient’s BP was performed four to 12 hours after the BP was obtained at 0900 hours as per the POC. On 4/13/22 at 0900 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. The Administrator/DPCS was informed and acknowledged the finding. 2. Review of Patient 4’s closed clinical record was initiated on 4/7/22. The closed clinical record showed the SOC was 9/2/17. The patient was certified for home health services during the certification periods from 10/11/21 to 12/9/21, and 12/10/21 to 2/7/22. The POC, for the certification period from 10/11/21 to 12/9/21, showed LVN visits 660 hours Q 30 days (150 hours Q 30 days of shared LVN to be shared with sibling and 510 hours Q 30 days of individual LVN nursing) for 60 days. The POC showed skilled observation and assessment of all systems, including temperature, pulse, respiration, and pain Q four hours and PRN for complications. * The SN notes dated 10/17/21 to 11/15/21, showed the SN visited the patient 480 hours in 30 days instead of 510 hours. Review of the SN notes showed the patient’s temperature was not obtained Q four hours as ordered. For example: * The SN notes dated 12/8 and 12/9/21, from 1600 to 0800 hours, showed temperature was obtained at 0800 and 1600 hours only. b. The POC, for the certification period from 12/10/21 to 2/7/22, showed LVN visits 660 hours Q 30 days (150 hours Q 30 days of shared LVN to be shared with sibling and 510 hours Q 30 days of individual LVN nursing) for 60 days. The POC showed skilled observation and assessment of all systems, including temperature, pulse, respiration, and pain Q four hours and PRN for complications * The SN notes dated 12/16/21 to 1/14/22, showed the SN visited the patient for 470 hours in 30 days instead of 510 hours. Review of the SN notes showed the patient’s temperature was not obtained Q four hours as ordered. For example: * The SN notes dated 1/14, 1/15/ 1/16, and 1/17/22, from 1600 to 0800 hours, showed the patient's temperature was obtained at 0800 and 1600 hours only. On 4/13/22 at 0930 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the finding. She stated there should be 510 hours of SN visits for 30 days. 3. Review of Patient 3’s closed clinical record was initiated on 4/7/22. The closed clinical record showed the SOC was 12/9/18. The patient was certified for home health services during the certification periods from 5/27/21 to 7/25/21, and 7/26/21 to 9/23/21 The POC, for the certification period from and 7/26/21 to 9/23/21, showed the following information: - 8 ounces of macadamia smoothie plus 100 ml “Kangen” water at 1400 hours PRN to promote weight gain until reaching a maximum weight between 130-135 pounds. -flush G-tube with 10 ml water before and after each use. a. The Treatment Record dated 8/21/21, showed 8 ounces of smoothie protein mix plus 100 ml “Kangen” water at 1400 hours was administered. The SN note dated 8/21/21 at 1400 hours, showed there was 240 ml of feeding plus 210 ml of water administered. * However, there was no documented evidence of indication such as the patient's weight for the administration of the PRN feeding at 1400 hours. b. The Treatment Record from 8/22/21 to 8/28/21, showed the GT was flushed with 30 ml of water before and after each use instead of 10 ml of water before and after each use as per the POC On 4/13/22 at 0830 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the finding. 4.a. Review of Patient 2’s clinical record was initiated on 4/5/22. Review of Patient 2’s clinical record showed the SOC was 5/19/16. The clinical record showed the patient received home health services during the certification periods from 12/20/21 to 2/17/22, and 2/18/22 to 4/18/22. The POC, for the certification period from 12/20/21 to 2/17/22, showed to perform skilled observation and assessment of all systems, including temperature, pulse, respiratory rate, and pain every shift and as needed for complications. Review of the RN/LVN Shift Clinical Note dated 1/12/22, showed no documented evidence the pain was assessed as cited in the POC. Review of the RN/LVN Shift Clinical Note dated 1/13/22, showed no documented evidence the pulse and respiratory rates were assessed as cited in the POC. Further review of Patient 2’s clinical record failed to show documented evidence explaining why the vital signs mentioned above were not assessed. On 4/13/22 at 0820 hours, an interview and concurrent clinical record review was conducted with the CEO. The CEO verified the findings. b. The POC, for the certification periods from 12/20/21 to 2/17/22 and 2/18/22 to 4/18/22, showed the SN duties included to change the patient’s position every 2 hours when in bed. Further review of Patient 2’s clinical record showed the SN visited the patient’s home on 12/26/21, 1/2, 1/9, 1/16, 1/23, 2/6, 2/13, 2/20, 2/27, and 3/6/22. The SN started the work shift from 1900 hours to 0700 hours. Review of the Treatment Records for the dates listed above showed no documented evidence the patient’s position was changed every two hours from 0100 hours to 0500 hours, as per the POC. On 4/13/22 at 0834 hours, an interview and concurrent clinical record review was conducted with the CEO. The CEO verified the findings. 5. Review of Patient 5’s clinical record was initiated on 4/6/22. The clinical record showed the SOC was 9/4/19. The patient was certified for home health services during the certification periods from 1/14/22 to 3/14/22, and 3/15/22 to 5/13/22. The POC, for the certification periods 1/14/22 to 3/14/22 and 3/15/22 to 5/13/22, showed the nutritional requirements included Nutren 1.5 cal, administer four cans in five divided feedings, and to administer 135 ml, wait one hour, then administer the remaining 135ml 4 times a daily via slow gravity G-Tube bolus. The SN notes dated 3/8, 3/14, 3/29, 3/30, and 4/2/22, showed Patient 5 received four feedings of 250ml of Nutren 1.5cal. However, there was no documented evidence Patient 5 received five divided feedings as per the POC. On 4/13/22 at 0810 hours, a concurrent interview and clinical record review was conducted with LVN 1. LVN 1 was informed and acknowledged the finding. 6. Review of Patient 1's clinical record was initiated on 4/6/22. The clinical record showed the SOC was 12/11/08. The patient was certified for home health services during the certification period from 12/02/21 to 1/30/22. The POC, for the certification periods 12/02/21 to 1/30/22 and 1/31 to 3/31/22, showed the gastrostomy care included to assess stomach residual prior to each feeding and record amount. Review of the SN notes dated 1/15. 1/19, 1/21, 1/22, 1/26, 3/25 3/26. 3/30, 3/31/22, showed the patient's residual was checked at 1900 hours, and showed feedings were provided twice during the shift. However, further review of the SN notes failed to show the patient's residual checks were done prior to each feeding. On 4/13/22 at 0915 hours, an interview and concurrent clinical record review was conducted with LVN 1. LVN 1 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 four of seven sampled patients (Patients 2, 3, 5, and 7). This failure created the increased risk of substandard health outcomes to the patients. Findings: 1. Review of Patient 7's clinical record was initiated on 4/7/22. The closed clinical record showed the SOC was 12/27/17. The patient was certified for home health services during the certification period from 2/4/22 to 4/4/22. a. The POC, for the certification period from 2/4/22 to 4/4/22, showed under the nutrition section, to administer water at 40 ml/hour via G-tube via pump from 2300 to 0300 hours. Another section of the POC, under gastrointestinal/gastrostomy care showed to administer water at 40 ml/hour via G-tube via pump from 2200 to 0300 hours via G-tube pump. * There were two different duration when to administer the water via G-tube in the POC. b. Review of the SN notes dated 2/4, 2/5, 2/6, 2/7, 2/8, 2/13, 3/21, and 3/25/21 (from 2200 to 0700 hours), showed the patient’s intake at 2200, 2300, 2400, 1000, and 0200 hours was 40 ml at each hour. Documentation showed at 0300 hours, the intake was at 20 ml. The Treatment Records dated 2/4, 2/5, 2/6, 2/7, 2/8, 2/13, 3/21, and 3/25/21, showed the water was administered at 40 ml/hour from 2300 to 0300 hours. The section of the Treatment Record which included the time showed the pump was on at 2200 hours and off at 0300 hours, wherein the time to start administering water was not consistent. In addition, there were inconsistencies for the patient’s intake at 0300 hours, recorded in the above SN notes which showed 20 ml, instead of 40 ml per hour in the Treatment Records. On 4/13/22 at 0900 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She stated the correct order in the POC was to administer water at 40 ml/hour via G-tube via pump from 2200 to 0300 hours, and not 2300 to 0300 hours. She was informed and acknowledged the finding. 2. Review of Patient 3’s closed clinical record was initiated on 4/7/22. The clinical record showed the SOC was 12/9/18. The patient was certified for home health services during the certification periods from 5/27/21 to 7/25/21, and 7/26/21 to 9/23/21 a. The POCs, for the certification periods from 5/27/21 to 7/25/21 and 7/26/21 to 9/23/21, showed the patient had the G-tube and following nutritional requirements: - 8 ounces of macadamia smoothie plus 100 ml “Kangen” water at 1000 hours - 8 ounces of macadamia smoothie plus 100 ml “Kangen” water at 1400 hours PRN to promote weight gain until patient reaches a maximum weight between 130-135 pounds. The Treatment Record from 8/22/21 to 8/28/21, showed the following information: - 8 ounce of smoothie protein mix and Kangen” water daily via GT via feeding pump at a rate of 400 ml/hour and administration times were at 0800 and 1400 hours. * However, the specific kind of smoothie was not accurately documented in the Treatment Record . In addition, the 8 ounce macadamia smoothie plus 100 ml “Kangen” water at 1400 hours PRN was documented with an administration time of 1400 hours, not PRN. b. Review of the SN notes showed inconsistencies of the patient’s intake. For example: The SN notes dated 8/22/21 (0700-1500), showed the patient’s intake for feeding was “360” and “150” as water flush at 1030 hours. The Treatment Record dated 8/22/21, showed 8 ounce of Smoothie protein mix and 100 ml of Kangan water was administered at 1000 hours; and the G-tube was flushed with 30 ml of water before and after each use which was timed at 0700 to 1500 hours. * However, the amount of feeding intake documented in the SN notes was not consistent with amount of feeding in the Treatment Record. On 4/13/22 at 0830 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. She was informed and acknowledged the finding. 4. Review of Patient 2’s clinical record showed the SOC was 5/19/16. The clinical record showed the patient received home health services during the certification periods from 12/20/21 to 2/17/22, and 2/18/22 to 4/18/22. The POCs, for the certification periods from 12/20/21 to 2/17/22, and 2/18/22 to 4/18/22, showed to document Patient 2’s intake and output. Review of the RN/LVN Shift Clinical Notes dated 1/12, 1/13, 1/19, 2/15, and 3/30/22, showed inaccurate documentation of the patient’s intake and/or output. For example, on 3/30/22, the SN documented the patient’s total output was 1050 ml; however, the total output was 1100 ml. On 4/13/22 at 0815 hours, an interview and concurrent clinical record review was conducted with the CEO. The CEO verified the findings. 5. Review of Patient 5’s clinical record was initiated on 4/6/22. The clinical record showed the SOC was 9/4/19. The patient was certified for home health services during the certification periods from 1/14/22 to 3/14/22, and 3/15/22 to 5/13/22. The POC, for the certification period 3/15/22 to 5/13/22, showed the G-Tube care included to flush G-Tube with 60 ml water after each use and as needed to ensure patency. Review of Patient 5’s Treatment Record from 3/15/22 to 4/2/22, showed the SN flushed the G-Tube with 60 ml of water before and after each use and as needed. Review of Patient 5's SN notes dated 3/25, 3/28, 3/29, 3/30, 4/1, 4/2/22, showed Patient 5 received 100 or 130 ml of water. However, the amount of water flushes were not consistent with the amount of water flushes on the treatment record. On 4/13/22 at 0810 hours, a concurrent interview and clinical record review was conducted with LVN 1. LVN 1 was informed and acknowledged the finding.

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 clinical record review, the agency failed to ensure the agency’s RN provided supervisions to the SN to ensure quality of care and services provided for three of seven sampled patients (Patients 2, 4, and 7), creating the risk of substandard healthcare outcomes to these patients. Findings: 1. Review of Patient 7’s clinical record was initiated on 4/7/22. The clinical record showed the SOC was 12/27/17. The patient was certified for home health services during the certification period from 2/4/22 to 4/4/22. The POC, for the certification period from 2/4/22 to 4/4/22, cited LVN visits 660 hours/30 days for 60 days and RN visit for management and evaluation of the plan of care two hours per month for two months. The POC showed LVN duties included skilled observation and assessment of all systems, including temperature, pulse, respiration, BP, and pain Q four to twelve hours and PRN for complications. The SN note showed the SN failed to provide care and services in accordance with the POC. Cross reference to G710, example #1. Further review of the clinical record showed the RN had conducted the LVN supervisory visit on 3/31/22, to ensure the LVN had followed the POC. However, the RN failed to identify the LVN did not perform the tasks as cited in the POC. On 4/13/22 at 0900 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. The Administrator/DPCS was informed and acknowledged the finding. 2. Review of Patient 4’s closed clinical record was initiated on 4/7/22. The clinical record showed the SOC was 9/2/17. The patient was certified for home health services during the certification periods from 10/11/21 to 12/9/21, and 12/10/21 to 2/7/22. The POC, for the certification period from 12/10/21 to 2/7/22, cited LVN visits 660 hours Q 30 days (150 hours Q 30 days of shared LVN to be shared with sibling and 510 hours Q 30 days of individual LVN) for 60 days. The POC showed skilled observation and assessment of all systems, including temperature, pulse, respiration, and pain Q four hours and PRN for complications The SN notes showed the SN failed to provide care and services in accordance with the POC. Cross reference to G710, example #2. Further review of the clinical record showed the RN had conducted the LVN supervisory visit on 12/31/21, to ensure the LVN had followed the POC. However, the RN failed to identify the LVN did not perform the tasks as cited in the POC. On 4/13/22 at 0930 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. The Administrator/DPCS was informed and acknowledged the finding 3. Review of Patient 2’s clinical record was initiated on 4/5/22. The clinical record showed the SOC was 5/19/16. The clinical record showed the patient received home health services during the certification periods from 12/20/21 to 2/17/22, and 2/18/22 to 4/18/22. The RN/LVN Shift Clinical Notes showed the SN did not provide care and services in accordance with the POC for this patient. Cross reference to G710, example #4. Further review of the clinical record showed the RN supervisory visits were conducted on 1/13/22 and 3/15/22. However, the RN failed to identify the SN did not provide care and services in accordance with the POC . On 4/13/22 at 0834 hours, the CEO was informed of the finding.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on observation, interview, and clinical record review, the agency's Administrator failed to be responsible for the day to day operations related the P&P implementation for one of seven patients (Patient 7). This failure created the risk of not providing quality of care and services to the patients receiving services from the HHA. Findings: Review of the agency's Job Description for Administrator showed the essential job functions included planning, directing, and controlling the overall operational/services. The Administrator's responsibility included organizing and directing the planning of agency's operations, services and functions; and participating in ensuring 100% compliance with all Federal and State regulations, reimbursement criteria as well as agency policies and procedures at all times. Review of the agency's P&P titled Medication Administration: Gastrostomy Tube dated 2/97 showed the following: - To put the patient in semi-fowlers position. - Keep her in this position during enteral administration and for at least 30 minutes afterward. - Remove the G-tube plunger and attach a 30 to 60 ml piston syringe. - Release the G-tube clamp. - To verify G-tube placement and patency, aspirate for gastric contents, note the residual volume, and follow your facility’s policy for instilling it. - Clamp the G-tube, remove the syringe, and take out the plunger, reattach the syringe and unclamp the G-tube. Pinch the tubing to seal it and add 30 ml of water to the syringe. - Release the tubing, let the water flow by gravity to flush it, and pinch it again before the syringe empties. Pour the diluted medication into the syringe and release the tubing to administer it, if you are giving more than one drug, flush between each dose with 15 to 30 ml of water. When finished flush with 30 ml of water, clamp the G-tube and replace the plug Review of Patient 7's clinical record was initiated on 4/7/22. The clinical record showed the SOC was 12/27/17. The patient was certified for home health services during the certification period from 2/4/22 to 4/4/22. A joint home visit with LVN 3 was conducted on 4/7/22 at 1000 hours, to Patient 7's home. LVN 3 was observed performing medication administration via G-tube for Patient 7. LVN 3 had prepared the medications prior to the observation. Most of the medications were placed in small syringes. LVN 3 washed her hands. LVN 3 connected the syringe to the patient’s G-tube. LVN 3 administered Miralax (laxative) into the patient’s G-tube followed by 50 ml of Peptamen Junior (nutritional formula). LVN 3 administered eight medications from the prepared medication syringes via the patient’s G-tube, one medication after the other. LVN 3 was unable to state the name of medications from each small syringes while the medications were being administered. LVN 3 flushed the patient’s G-tube with 60 ml of water. * However, LVN 3 did not flush the G-tube with water before medication administration and did not flush with 15 to 30 ml water between each medication administered as per the agency’s P&P. On 4/13/22 at 0900 hours, an interview and concurrent clinical record review was conducted with the Administrator/DPCS. The Administrator/DPCS was informed and acknowledged the finding.