Every finding on record at Visiting Nurse Association of Southeast Missouri, Inc

The Emergency Preparedness regulations were reviewed as part of the Medicare recertification survey completed on 08/06/2025. During the survey it was determined the home health provider is in compliance with the requirements of 42 CFR 484.102 Condition of Participation: Emergency Preparedness for Home Health Providers.

A partial extended survey for Medicare recertification for the home health provider was completed on 08/06/2025. The provider had 191 current patients.

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 policy review, record review, home visit observation, and interview, the home health provider failed to ensure staff maintained an accurate/updated medication profile in three of three home visit observations conducted (Records/Patients #1, #2, and #3). This deficient practice has the potential to affect all the patients served by the provider. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 07/17/2025 with a primary diagnosis of cervical radiculopathy (injury or damage to nerve roots in the area where they leave the spine at the neck). The patient resided in his/her own home with the assistance of his/her adult children daily. Review of the provider’s current medication profile showed in part: - Gabapentin (a medication used to treat nerve pain) one capsule daily; and - Losartan (a medication used to lower blood pressure) one tablet by mouth daily. Observation and interview on 08/05/2025 at 9:15 AM showed the following medication regimen discrepancies: - He/she had not taken the gabapentin since he/she was discharged from the hospital on 07/13/2025; and - He/she had stopped taking the losartan on 07/17/2025 at the request of his/her adult children because of low blood pressure. During an interview on 08/06/2025 at 10:25 AM, the administrator stated they would expect their clinicians to perform medication reconciliation each visit. Findings included: Review of the provider’s policy titled, “Medication Reconciliation” dated 2020, showed in part: PURPOSE: - The purpose of Medication Reconciliation is to compare a patient's medication orders to all the medications that the patient has been taking, including any herbs or over the counter (OTC) medications; - This reconciliation is done to avoid medication errors such as omissions, duplication, dosing errors, or drug interactions; and - A medication reconciliation is a formal process for creating the most complete and accurate list possible of a patient's current medication list and comparing this list to those in the patient's medical records. Steps of Medication Reconciliation: - Collect an accurate medication history by asking the patient to gather all the medications they may take including supplements and OTC medications. Home health includes all medications they may have taken in the last 30 days; - Clarify the medication names, strengths, routes, and frequency with the patient/legal representative; - Reconcile the medications in the home with the physician or hospital/facility if current medication orders were received with referral. The hospice nurses will consult the hospice physician/attending physician regarding new medications needed, discontinuation of any current medications, and to determine what meds are related or not related to the hospice care that is ordered upon admission to hospice and as needed thereafter; - Home health nurses must contact the physician or hospital/facility and have them send an official list of medications for the patient to complete a medication reconciliation if the referral did not originally send one; and - If there is a discrepancy, contact the physician for order clarification. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health services on 02/28/2025 with a primary diagnosis of an above the knee amputation of the left leg, and secondary diagnoses which included Peripheral Vascular Disease (PVD; condition where blood vessels outside of the heart and brain narrow, affecting blood flow to limbs), hypertension, (abnormally high blood pressure), and diabetes (a group of diseases that results in too much sugar in the blood). The patient resided at home with a spouse. Observation and interview on 08/05/2025 at 10:45 AM, during the patient’s home visit, showed the following medication discrepancies with the provider’s medication profile: -The medication profile showed an order for melatonin (an OTC hormone that helps regulate sleep-wake cycles) 3 milligrams (mg) tablet, take one tablet by mouth, daily at hour of sleep (HS) The patient stated that he/she had not used the medication; -The medication profile showed an order for methocarbamol (a medication to relieve pain and muscle spasms ) 500 mg tablet, one tablet to be taken by mouth, every eight hours as needed. The patient stated that he/she no longer used the medication; -The patient took trazadone (an antidepressant) 50 mg tablet, take one tablet, by mouth, daily at HS. This medication was not included on the provider's medication profile; and -The patient took vitamin D3 (a vitamin supplement),1.25 mg tablet, take one tablet, by mouth, each month. This medication was not included on the provider's medication profile. During an interview on 08/05/2025 at 11:30 AM, physical therapist (PT) - A stated he/she does not normally visit the patient, however, each patient should have their medication checked and compared to the current medication list during each visit to ensure accuracy. PT- A stated that he/she would notify the patient’s nurse regarding the discrepancies. During an interview on 08/06/2025 at 10:25 AM, the administrator stated that all staff should follow the policy, which consists of the visual comparison of all current medications in the patient’s home to the medication list during each visit to ensure accuracy. Findings included: Review of the provider’s policy titled, “Medication Reconciliation,” dated 2020, showed in part: - Purpose: * The purpose of Medication Reconciliation is to compare a patient's medication orders to all the medications that the patient has been taking, including any herbs or over the counter (OTC) medications; * This reconciliation is done to avoid medication errors such as omissions, duplication, dosing errors, or drug interactions; and * A medication reconciliation is a formal process for creating the most complete and accurate list possible of a patient's current medication list and comparing this list to those in the patient's medical records. - Steps of Medication Reconciliation: * Collect an accurate medication history by asking the patient to gather all the medications they may take including supplements and OTC medications. Home health includes all medications they may have taken in the last 30 days; * Clarify the medication names, strengths, routes, and frequency with the patient/legal representative; * Reconcile the medications in the home with the physician or hospital/facility if current medication orders were received with referral. The hospice nurses will consult the hospice physician/attending physician regarding new medications needed, discontinuation of any current medications, and to determine what meds are related or not related to the hospice care that is ordered upon admission to hospice and as needed thereafter; * Home health nurses must contact the physician or hospital/facility and have them send an official list of medications for the patient to complete a medication reconciliation if the referral did not originally send one; and * If there is a discrepancy, contact the physician for order clarification. RECORD/PATIENT #1: Review of the clinical record showed the patient was admitted to home health services on 02/28/2025 with a primary diagnosis of an above the knee amputation of the left leg, and secondary diagnoses which included peripheral vascular disease (PVD; condition where blood vessels outside of the heart and brain narrow, affecting blood flow to limbs), hypertension, (abnormally high blood pressure), and diabetes (a group of diseases that results in too much sugar in the blood). The patient resided at home with a spouse. Observation and interview on 08/05/2025 at 10:45 AM, during the patient’s home visit, showed the following medication discrepancies with the provider’s medication profile: -The medication profile showed an order for melatonin (an OTC hormone that helps regulate sleep-wake cycles) 3 milligrams (mg) tablet, take one tablet by mouth, daily at hour of sleep (HS) The patient stated that he/she had not used the medication; -The medication profile showed an order for methocarbamol (a medication to relieve pain and muscle spasms ) 500 mg tablet, one tablet to be taken by mouth, every eight hours as needed. The patient stated that he/she no longer used the medication; -The patient took trazadone (an antidepressant) 50 mg tablet, take one tablet, by mouth, daily at HS. This medication was not included on the provider's medication profile; and -The patient took vitamin D3 (a vitamin supplement),1.25 mg tablet, take one tablet, by mouth, each month. This medication was not included on the provider's medication profile. During an interview on 08/05/2025 at 11:30 AM, physical therapist (PT) - A stated he/she does not normally visit the patient, however, each patient should have their medication checked and compared to the current medication list during each visit to ensure accuracy. PT- A stated that he/she would notify the patient’s nurse regarding the discrepancies. During an interview on 08/06/2025 at 10:25 AM, the administrator stated that all staff should follow the policy, which consists of the visual comparison of all current medications in the patient’s home to the medication list during each visit to ensure accuracy. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 02/28/2025 with a primary diagnosis of encounter for adjustment and management of VAD (vascular access device - a medical device used to gain long-term access to a patient’s bloodstream for administering medications, fluids or for blood draws). The patient had additional diagnoses of osteomyelitis of cervical vertebrae (infection of the bone of the spine) and current long-term use of antibiotics. The patient lived in his/her own home and had a sibling who assisted with care as needed. Observation and interview on 08/05/2025 at 9:30 AM, showed: -The provider’s medication list had acetaminophen (used for mild pain/fever) 325 milligrams (mg) two tablets per g-tube (enteral feeding tube; a tube placed surgically through the abdominal wall into the stomach for the administration of food, fluids, and medication), every six hours. The patient stated that he/she had not used it for quite a while; -The provider’s medication list had amlodipine (for blood pressure) 10 mg per g-tube, daily. The patient stated that he/she took the medication by mouth and had not taken it per g-tube for a while; -The provider’s medication list had losartan (for blood pressure) 100 mg per g-tube, daily. The patient stated that he/she took the medication by mouth and had not taken it per g-tube for a while; -The provider’s medication list had Osmolite 1.5 Cal (refers to calories per milliliter (mL)) liquid (nutritional supplement) per g-tube four times a day. The patient stated that he/she had been drinking it by mouth; -The provider’s medication list had oxycodone (narcotic pain medication) 5 mg/5 mL, per g-tube every four hours, as needed (PRN) for pain. The patient stated that he/she had not taken it since he/she was discharged from the hospital (on 02/02/2025); -The provider’s medication list had senna plus (for constipation) 8.6mg-50mg, one tablet twice daily per g-tube. The patient stated that he/she had not taken the medication since he/she was discharged from the hospital; - The provider’s medication list had chlorhexidine gluconate 0.12% mouthwash (used to reduce bacteria in the mouth), 15mL four times daily. The bottle in the patient’s home, last filled on 07/16/2025, showed the patient was to use the mouthwash twice a day; - The patient had an antibiotic, amoxicillin 400mg – potassium clavulanate 57mg/5 mL, two times a day for 10 days per g-tube. The provider’s medication list failed to include the duration for the antibiotic; and - The patient had a bottle of hydrocodone (narcotic pain medication)/ acetaminophen 10 mg/325 mg, take one by mouth three times a day PRN. The label was dated/filled 07/08/2025 and the provider’s medication list failed to include the hydrocodone. During an interview on 08/06/2025 at 10:23 AM, the administrator stated that staff should have reconciled the patient’s medication at every visit and updated the profile with any changes. He/She would expect staff to notify the patient’s physician if the patient was no longer taking a medication. He/She would have expected all clinicians to have caught the medication discrepancies. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 07/17/2025 with a primary diagnosis of cervical radiculopathy (injury or damage to nerve roots in the area where they leave the spine at the neck). The patient resided in his/her own home with the assistance of his/her adult children daily. Review of the provider’s current medication profile showed in part: - Gabapentin (a medication used to treat nerve pain) one capsule daily; and - Losartan (a medication used to lower blood pressure) one tablet by mouth daily. Observation and interview on 08/05/2025 at 9:15 AM showed the following medication regimen discrepancies: - He/she had not taken the gabapentin since he/she was discharged from the hospital on 07/13/2025; and - He/she had stopped taking the losartan on 07/17/2025 at the request of his/her adult children because of low blood pressure. During an interview on 08/06/2025 at 10:25 AM, the administrator stated they would expect their clinicians to perform medication reconciliation each visit.

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 policy review, record review, and interview, the home health provider failed to ensure that the patient’s individualized plan of care (POC) included the types of services, supplies, and equipment needed for patient care in one of five full records reviewed (Record/Patient #4). This deficient practice has the potential to affect all of the patients served by the provider. Findings included: Review of the provider’s policy titled, “Care Planning & Coordination,” dated 03/2022, showed the individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment. RECORD/PATIENT #4: Review of the clinical record showed the patient was admitted to home health services on 07/20/2025 with a primary diagnosis of dysphagia (difficulty swallowing foods or liquids). The patient had a suprapubic urinary catheter (a catheter surgically inserted through the wall of the abdomen into the bladder) and and a gastrostomy tube (enteral feeding tube; a tube placed surgically through the abdominal wall into the stomach for the administration of food, fluids, and medication) He/she lived at home with a primary caregiver. Review of the POC, dated 07/20/2025 to 09/17/2025, showed “skilled nurse (SN) to instruct patient/caregiver in indwelling urinary catheter management including care of the suprapubic catheter” and “skilled nurse for teaching and administration of gastrostomy feedings to include care of equipment and preparation of feedings”. The POC failed to contain specific interventions and education for the care and maintenance for the suprapubic catheter and gastrostomy, including all gastrostomy equipment. During an interview on 08/06/2025 at 9:30 AM, the home health administrator stated that he/she could not locate specifics regarding catheter or gastrostomy tube care on the POC.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the home health provider failed to ensure clinicians promptly notified the patient's physician/allowed practitioner of any changes in the patient's condition or needs that suggested that outcomes were not being achieved and/or that the plan of care should be altered in two of five full records reviewed (Records/Patients #2 and #3). This deficient practice has the potential to affect all the patients served by the provider. Findings included: RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 07/17/2025 with a primary diagnosis of cervical radiculopathy (injury or damage to nerve roots in the area where they leave the spine at the neck). The patient resided in his/her own home with the assistance of his/her adult children daily. Review of the provider’s current medication profile showed in part: - Gabapentin (a medication used to treat nerve pain) one capsule daily; and - Losartan (a medication used to lower blood pressure) one tablet by mouth daily. Observation and interview on 08/05/2025 at 9:15 AM, showed that the patient had not taken gabapentin, and stated that he/she had not taken the gabapentin since he/she was discharged from the hospital on 07/13/2025, and losartan since 07/17/2025 related to low blood pressure. Review of the nursing visit note dated 08/5/2025 showed in part that: - The patient reported he/she was not taking gabapentin and losartan; - The nurse discontinued the medications and marked them off the patient’s medication list that was left in the home; - The visit note failed to contain documentation that the skilled nurse notified the physician that the patient was not taking gabapentin and losartan. During an interview on 08/06/2025 at 10:25 AM, the administrator stated that they would expect clinicians to notify the physician of when a patient was not taking his/her medications as prescribed, and they were unable to locate documentation that the physician had been notified that the patient was not taking gabapentin and losartan. Review of the provider's policy titled, “Licensed Practical Nurse Job Description,” dated 07/2021, showed, in part, the following job duties/responsibilities: -Makes pertinent nursing observations and communicates these to the R.N. (registered nurse) Staff Nurse or the physician and/or case worker when appropriate and document in a timely manner; -Inform doctor of changes in patient’s conditions, with documentation of changes in narrative notes; and -Follow the plan of care as initiated by the R.N./physician. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 02/28/2025 with a primary diagnosis of encounter for adjustment and management of VAD (vascular access device - a medical device used to gain long-term access to a patient’s bloodstream for administering medications, fluids or for blood draws). The patient had additional diagnoses of osteomyelitis of cervical vertebrae (infection of the bone of the spine) and current long-term use of antibiotics. The patient lived in his/her own home and had a sibling who assisted with care as needed. Review of the recertification plan of care (POC), dated 06/28/2025 to 08/26/2025, showed in part: -Skilled nurse (SN) was to obtain CBC with differential (complete blood count – a blood test that provides information about the different types of cells in your blood, including red blood cells, white blood cells and platelets) and CMP (complete metabolic panel – a blood test that measures 14 different substances in your blood, providing a broad overview of your body’s metabolism and chemical balance) weekly; and -SN was to perform IV (intravenous, in the vein) flush of each lumen (port) of power PICC (Peripherally Inserted Central Catheter - a catheter inserted into a peripheral vein and ending in a large vessel above the heart) line as follows: after discontinuing infusion, after each use or every 24 hours – flush central line with ten cc (cubic centimeters) of normal saline (NS) followed by three to five cc heparin (to keep blood from clotting). When drawing blood, flush with ten cc NS, withdraw three to five cc of blood using a five cc syringe and discard, draw blood for lab using a five cc syringe, flush with 20cc NS using a pulsating method, follow with three to five cc heparin. Review of the SN visit note, dated 07/01/2025, showed in part, the patient had a double lumen PICC line to the left upper arm. The nurse attempted to draw labs from PICC line with no blood return noted. The lines flushed without difficulties. The SN drew blood from right antecubital (AC, area to inner elbow) without difficulties. The POC and physician orders failed to include an order for venipuncture (the process of puncturing a vein with a needle to draw blood) to obtain blood draws. During interview on 08/06/2025 at 10:23 AM, the administrator stated that he/she would expect the staff to contact the patient’s physician to obtain an order for venipuncture for blood work if they were unable to draw blood from the patient’s PICC line.

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 policy review, record review, home visit observation, and interview, the provider failed to ensure the clinicians provided services that are ordered by the physician or allowed practitioner as indicated in the plan of care in one of five full records reviewed (Record/Patient #2). This deficient practice has the potential to affect the provision of care for all the provider’s patients. Findings included: Review of the provider's policy titled, "Job Description Registered Nurse (RN)," dated 10/2021 showed, in part, the RN makes initial evaluation visits as assigned, assesses patient needs, and provides skilled nursing care and prescribed treatments as ordered by the physician. Review of the provider's policy titled, “Job Description LPN (Licensed Practical Nurse),” dated 07/2021, showed, in part, the duties of the LPN included: -Makes pertinent nursing observations and communicates these to the R.N. / Staff Nurse or the physician and/or case worker when appropriate and document in a timely manner; -Inform doctor of changes in patient’s conditions, with documentation of changes in narrative notes; and -Follow the plan of care as initiated by the R.N./physician. RECORD/PATIENT #2: Review of the clinical record showed the patient was admitted to home health services on 02/28/2025 with a primary diagnosis of encounter for adjustment and management of VAD (vascular access device - a medical device used to gain long-term access to a patient’s bloodstream for administering medications, fluids or for blood draws). The patient had additional diagnoses of osteomyelitis of cervical vertebrae (infection of the bone of the spine) and current long-term use of antibiotics. The patient lived in his/her own home and had a sibling who assisted with care as needed. Review of the plan of care (POC) dated 06/28/2025 to 08/26/2025, showed the patient had a power PICC (Peripherally Inserted Central Catheter – a catheter inserted into a peripheral vein and ending in a large vessel above the heart) in the left arm. Staff were to measure arm circumference weekly for edema (swelling of tissues): "From insertion site, measure up to the mid bicep area. Measure around the arm to see if there is a change. If increase in cm (centimeters) circumference, notify physician". Review of the LPN visit notes completed on 07/01/2025, 07/08/2025, 07/15/2025, 07/22/2025, and 07/29/2025, failed to contain documentation that the nurse measured the circumference of the patient’s left upper arm. Observation on 08/05/2025 at 9:30 AM, showed the RN performed the following interventions to the patient's left arm PICC site: - Sterile dressing change; - Changed the extension tubing and caps; - Drew blood for labs; - Flushed ports; and - The RN failed to obtain measurements of the left upper arm as ordered in the POC. Per an interview conducted immediately following the home visit, RN-D stated that he/she did not measure the arm circumference, but it was still an active order. The dressing change kit usually came with a measuring tape. He/she did not see one in the kit, and he/she did not remember to measure the upper arm. During an interview on 08/05/2025 at approximately 11:00 AM, the administrator stated that RN-D had called the office after the home visit and he/she sent RN-D back into the patient's home to obtain the upper arm measurement because it should have been measured. During an interview on 08/06/2025 at 10:34 AM, the administrator stated that he/she would expect the staff to follow the plan of care and measure the arm circumference of the patient during each visit.

The Emergency Preparedness regulations were reviewed as part of the Medicare recertification survey completed on 08/31/2022. During the survey it was determined the home health provider is in compliance with the requirements of 42 CFR 484.102 Condition of Particpation: Emergency Preparedness for Home Health Agencies.

A partial extended survey for Medicare recertification for the home health provider was completed on 08/31/2022. The agency had 196 current patients. The COVID-19 Health Care Staff Vaccination regulation was reviewed as part of the Medicare recertification survey. One standard-level deficiency was identified.

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on policy review, record review, and interview, the agency failed to ensure the accuracy of the Outcome and Assessment Information Set (OASIS) data in, but not limited to, one (Record/ Patient #3) of five full records reviewed. This deficient practice has the potential to affect the accuracy of OASIS data collection for all of the agency’s patients. Findings included: Review of the agency’s policy titled, “OASIS D Policies,” dated/revised 02/2019, showed in part: - The purpose is to ensure that a comprehensive assessment is completed utilizing assessment information and OASIS data items at the assigned intervals as defined by CMS (Centers for Medicare and Medicaid Services) for the purpose of development of a systematic measurement of patient home health outcomes; - The OASIS is the key to outcomes measurement and performance improvement using outcomes; and - The encoded OASIS data must accurately reflect the patient’s status and be consistent with the current condition(s) of the patient at the time of the assessment. RECORD/PATIENT #3: Review of the document titled, “Established Office Visit,” dated 07/11/2022, showed a physician signed order for a home health consult to include physical therapy. Review of the document titled, “Outpatient Request Form,” dated 07/11/2022, showed a physician signed order for physical therapy. Review of the agency’s document titled, “Intake Form Demographic and Insurance,” signed by the agency’s licensed practical nurse and dated 07/15/2022, showed: - Referral date was entered as 07/13/2022; and - Requested/doctor ordered start of care date was entered as 07/18/2022. Review of the agency’s unsigned document titled, “Client Coordination Note Report,” dated 07/15/2022, showed: - Note (Mandatory) – Date doctor ordered patient to be seen for home care visit- SOC/ROC (start of care/resumption of care) – (M0102): 07/18/2022; and - The question, was contact made with PCP (primary care physician)? Yes or No, is left blank. Review of the document titled, "RN (registered nurse) OASIS Admission," dated 07/18/2022, showed the date of the specific physician ordered start of care/resumption of care date when the patient was referred for home health services (M0102) was answered as 07/18/2022. The clinical record failed to show an order for a physician ordered start of care date of 07/18/2022. During an interview on 08/30/2022 at 11:00 AM, the administrator stated that the agency did not have an actual order from the physician to start care on 07/18/2022. He/she was unaware that an actual order was required to delay the start of care. The agency intake nurses are licensed practical nurses (LPNs) and they communicate with the physician’s offices regarding new admissions but they do not write anything down as an order.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the agency failed to complete the initial assessment of the patient within 48 hours of the referral to home care, or 48 hours after the patient’s return home, or on the physician ordered start of care date in, but not limited to, one (Record/Patient #3) of five full records reviewed. This deficient practice has the potential to affect the immediate care needs of all the agency’s patients. Findings included: Review of the agency’s policy titled, “Initial and Comprehensive Assessment,” dated 02/2019, showed in part, the following: -The initial assessment is conducted by a registered nurse (RN) to determine the immediate care and support needs of the patient; -The initial visit must be done within 48 hours of referral date or within 48 hours of the patient’s return home or on the physician-ordered start of care date; - If the physician orders only therapy services, the initial assessment and comprehensive assessment most likely will be conducted by an RN but may be completed by an appropriate rehabilitation skilled professional within 48 hours of; * The time of referral; * The patient’s return home; and * The physician-ordered start of care date. RECORD/PATIENT #3: Review of the of the document titled, “Established Office Visit,” dated 07/11/2022, showed a physician signed order for a home health consult to include physical therapy. Review of the document titled, “Outpatient Request Form,” dated 07/11/2022, showed a physician signed order for physical therapy. Review of the agency’s document titled, “Intake Form Demographic and Insurance,” signed by the agency’s licensed practical nurse and dated 07/15/2022, showed: - Referral date was entered as 07/13/2022; and - Requested/doctor ordered start of care date was entered as 07/18/2022. Review of the document titled, "RN (registered nurse) OASIS (Outcome and Assessment Information Set) Admission," dated 07/18/2022, showed that: - The date of the specific physician ordered start of care/resumption of care date when the patient was referred for home health services (M0102) was answered as 07/18/2022; and - “From which of the following inpatient facilities was the patient discharged within the past 14 days?” (M1000) was answered as NA (not applicable), the patient was not discharged from an inpatient facility. The clinical record failed to show an order for a physician ordered start of care date of 07/18/2022. During an interview on 08/30/2022 at 11:00 AM, the administrator stated that the agency did not have an actual order from the physician to start care on 07/18/2022. He/she was unaware that an actual order was required to delay the start of care. The agency intake nurses are licensed practical nurses (LPNs) and they communicate with the physician’s offices regarding new admissions but they do not write anything down as an order.

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 policy review, record review, home visit observation, and interview the agency failed to ensure staff maintained an accurate/updated medication profile in two (Records/Patients #1 and #2) of three home visit observations. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #2: Observation and interview on 08/30/2022 beginning at 09:00 AM, during the patient’s home visit, showed the following medication discrepancies with the agency’s medication profile: - The medication profile showed an order for Ipratropium 0.5 milligrams (mg) – Albuterol 3 mg in 3 milliliters (mL) nebulization solution (an inhaled combination solution used to help control the symptoms of lung diseases). The patient stated that he/she does not take the nebulizers anymore; and - The patient had a bottle of swish and spit mouthwash (magic mouthwash), dated 01/2020, that contained equal parts antacid (used to coat the mouth), diphenhydramine (used to control swelling), and lidocaine (a numbing agent used to soothe pain). No dosages were given for the ingredients. The patient stated that he/she still used the mouthwash as needed and had been using it for the last few weeks. This medication was not included on the medication profile. Review of the medical record failed to show physician communication that the patient is still using the magic mouthwash. During an interview on 08/31/2022 at 9:00 AM, the administrator stated that he/she would expect the patient’s medications to be checked against the agency’s medication profile and reconciled with every visit. Findings included: Review of the agency's policy titled, “Medication Reconciliation,” dated/reviewed 02/2022, showed: - The purpose is to compare a patient’s medication orders to all the medications that the patient has been taking, including and herbs or over the counter (OTC) medications; - Collect an accurate medication history by asking the patient to gather all the medications they may take including supplements and OTC medications. Home health includes all medications they may have taken in the last 30 days; - Clarify the medication names, strengths, routes, and frequency with the patient/legal representative; and - Reconciliation is performed upon admission, resumption of care, recertification, discharge/transfer, and when any medication is added, changed, or discontinued. RECORD/PATIENT #1: Observation and interview on 08/30/2022, beginning at 1:55 PM, during the patient's home visit, showed the following medication discrepancies with the agency's medication profile: - The patient took Azithromycin (antibiotic) 250 milligrams (mg) one tablet daily for 30 days (filled 08/08/2022). The patient's caregiver stated that the patient had been on this since cominig home from the hospital. This was not included on the current medication profile. The medication profile showed an end date of 08/13/2022; - The patient took Zyrtec (allergy medication) 10 mg daily. The caregiver stated that he/she was not sure how long the patient had been taking this. This was not included on the medication profile. The medication profile showed Loratadine (a different allergy medication) 10 mg daily; and - The patient took cranberry extract 500 mg one tablet daily. The caregiver stated that the patient had taken this "quite a while". This was not included on the medication profile. During an interview on 08/30/2022 beginning at 3:45 PM, the administrator stated that medications should be reconciled at every visit.

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 policy review, record review, and interview the agency failed to ensure staff developed an individualized plan of care (POC) in four (Records/Patients #1, #2, #3, and #5) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #2: Review of the clinical record showed the patient was re-admitted to home health services on 02/02/2022 with a primary diagnosis of a stage three pressure ulcer (an injury to the skin and underlying tissue, primarily caused by prolonged pressure on the skin) to the left buttock. The patient had additional diagnoses of Type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar), Chronic venous hypertension (increased pressure inside the veins, also known as chronic venous insufficiency), hypertensive heart disease (a long term heart condition that develops over many years in people who have high blood pressure (HTN)), congestive heart failure (CHF, a condition in which the heart does not properly pump blood throughout the body), chronic obstructive pulmonary disease (COPD, a group of lung diseases that block airflow and make it difficult to breathe), and a history of metastatic lung cancer (cancer that spreads to other parts of the body). The patient lives in his/her own home with his/her spouse. Review of the agency’s plan of care (POC), dated 08/01/2022 through 09/29/2022, showed in part, the following orders: - Skilled Nurse (SN) for O/A (observation/assessment) of respiratory system to identify changes associated with exacerbation (worsening) of lung cancer, COPD, CHF, for early intervention of complications (does not specify frequency of assessment); - SN for O/A of cardiac system to identify changes associated with exacerbation of HTN for early intervention of complications (does not specify frequency of assessment); - SN to assess for signs/symptoms of CHF to identify changes associated with exacerbation of illness for early intervention of complications (does not specify frequency of assessment); - SN for O/A of endocrine status to identify changes associated with exacerbation of diabetes for early intervention of complications (does not specify frequency of assessment); - Diabetic foot care- SN to assess feet for skin lesions due to diabetes mellitus (does not specify frequency of assessment); and - SN for O/A of musculoskeletal status for early intervention of complications (does not specify frequency of assessment). Observations conducted during a home visit on 08/30/2022 at 9:00 AM showed the licensed nurse failed to: - Assess lower extremities for complications related to the cardiovascular system; and - Perform a diabetic foot assessment. During an interview on 08/31/2022 at 9:00 AM, the administrator stated that most interventions on the care plan are done every shift. The software used by the agency has a contact person who sets up the frequency of different interventions which prompt the clinician on their tablet. Education interventions that have been marked as a goal met will not show up again until the patient is recertified. The clinician would not be able to tell the frequency of the interventions by looking at the care plan but they should always assess. They should probably add the frequency on all interventions so the clinicians know what to do. RECORD/PATIENT #3: Review of the clinical record showed the patient was admitted to home health services on 07/18/2022 with a primary diagnosis of age related osteoporosis (a condition where the bones become weak and brittle) with a pathological fracture (a break in a bone caused by underlying disease) of the seventh vertebrae (one of the bones in the spine). The patient had additional diagnoses of hypertension (high blood pressure), depression, and a history of a left hip fracture. The patient lived at home with his/her parent. Review of the start of care assessment, dated 07/18/2022, showed: - The patient had the following fall risk factors: * A prior history of falls within the last three months; * Visual impairment; * Impaired functional mobility; - The patient required prompting (cuing, repetition, reminders) only under stressful or unfamiliar conditions; and - The patient was blind with vision severely impaired so that he/she cannot locate objects without hearing or touching them. Review of the plan of care (POC), dated 07/18/2022 through 09/15/2022, showed: - Physical therapy (PT) to visit two times a week for three weeks then one time a week for one week with interventions that included; * Instruction on safe transfers using appropriate body mechanics and equipment; * Evaluation of gait; * Evaluation of patient’s environmental management needs related to home safety; * Provide muscle re-education; * Pain management; * Education on assessment of skin for breakdown; * Observation/assessment of depression symptoms; - Licensed professional to report vital signs falling outside the following established parameters: * Temperature less than 95 degrees or greater than 100 degrees; * Pulse rate less than 50 beats per minute (bpm) or greater than 120 bpm; * Systolic (top number of blood pressure, the heart’s contracting phase) blood pressure less than 85 millimeters of mercury (mmHg) or greater than 180 mmHg; * Diastolic (bottom number of blood pressure, the heart’s resting phase) less than 50 mmHg or greater than 100 mmHg; * Pain less than zero or greater than five (on scale of zero to ten); * Pulse oximetry (measures the oxygen level in the bloodstream) less than 90 percent or greater than 100 percent; - The POC failed to contain individualized interventions specifically related to the patient’s blindness; and - The POC failed to specify the frequency that vital signs should be obtained by the clinician. Review of the PT notes with dates ranging from 07/18/2022 to 08/26/2022 showed the clinicians failed to document vital signs on 07/18/2022, 08/02/2022, and 08/13/2022. During an interview on 08/31/2022 at 9:00 AM, the administrator stated that if there are vital signs parameters listed on the POC, the expectation is for the clinician to obtain vital signs with each visit. He/she would expect the POC to be individualized to reflect that the patient is blind and have safety and other interventions specific to the patient’s blindness such as placing objects in reach and orientation to the placement of the objects and surroundings before treatment and before leaving the patient. Findings included: Review of the agency’s policy titled, “Care Planning and Coordination,” reviewed 03/2022, showed in part: - The purpose is to provide care, treatment, and/or services consistent with the type and frequency identified and documented in the POC and on the days and at the times scheduled with the patient/family/legal representative; - Each patient must receive an individualized written POC including any revisions or additions; and - The individualized POC must specify the care and services necessary to meet the patient-specific needs. Review of the agency's policy titled, “Physician Orders and Plans of Care,” dated/reviewed 03/2021, showed the contents of the POC will include a description of the treatment and/or procedure to be done, including, when appropriate, the type, frequency and duration. RECORD/PATIENT #1: Review of the registered nurse (RN) recertification visit note dated 07/01/2022 showed in part: - Diagnoses that included diabetes mellitus; - The endocrine (regulates hormonal control which includes blood sugar control) section showed no diabetes reported; and - Not applicable marked beside diabetic foot care. Review of the POC showed dated 07/06/2022 showed in part: - Diagnoses that included diabetes mellitus; - Interventions that included diabetic foot care and observation and assessment of endocrine status to identify changes associated with exacerbation of diabetes mellitus for early intervention of complications; and - No information regarding assessment or frequency of blood sugar checks and no parameters for reporting blood sugars. Review of the nursing visit note reports showed: - 07/13/2022, the patient took an antidiabetic agent and blood sugars were not routinely checked. No information regarding how often the blood sugars were checked and how they were running; and - 07/20/2022 the patient’s blood sugars had been stable for the past two weeks but no documentation of how often they were checked and what they had been running. Review of the RN resumption of care (after a hospitalization) visit note dated 08/09/2022 showed: - Diagnoses that included diabetes mellitus and two stage 2 (partial thickness skin loss) pressure ulcers; and - The patient’s blood sugars were checked daily and had been running in the 300s since he/she had been sick. Review of the resumption of care orders dated 08/09/2022 showed: - Observation and assessment of endocrine status to identify changes associated with exacerbation including diabetes mellitus for early intervention of complications; - The skilled nurse may check during the SN visits and/or record patient results (did not clarify whether this referred to blood sugar checks); and - No orders for frequency of blood sugar checks or parameters to be reported to the physician. Review of the nursing visit note reports from 08/10/2022 through 08/25/2022 showed the nurse documented the patient’s blood sugars had been stable or that the SN conducted an endocrine assessment but failed to document how often the blood sugars were being checked and how they had been running. During an interview on 08/30/2022, at 3:45 PM, the administrator stated that he/she would expect there to be an order for whether the blood sugars should be checked daily or as needed and for the blood sugar ranges to be documented. RECORD/PATIENT #5: Review of the POC dated 04/22/2022, showed: - Diagnoses that included diabetes mellitus and long term use of insulin; - SN visits one time for non-billable therapy services only; and - Physical therapy (PT) one time a week for one week then two times a week for three weeks. Review of an add on RN evaluation dated 06/21/2022, showed the patient had a wound to his/her right lower leg. Review of the POC dated 06/21/2022, showed: - Diagnoses that included diabetes mellitus and long term use of insulin; and - SN for observation and assessment of endocrine status to identify changes associated with exacerbation of diabetes mellitus for early intervention of complications. Patient/caregiver to check blood sugar daily and as needed for signs and symptoms of high or low blood sugar. SN may check during visits and/or record patient results; and - No parameters for when blood sugars should be reported to the physician. During an interview on 08/31/2022 beginning at 9:35 AM, the administrator stated that they only put orders for blood sugar parameters on the POC if the physician ordered parameters. If there is a routine order for checking blood sugars then they include parameters for reporting.

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on policy review, home visit observation, and interview, the agency failed to ensure the patient received written wound care instructions in one (Record/Patient #1) of three home visit observations. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled, "Care Planning and Coordination: Written Information to the Patient," reviewed 03/2022, showed in part that any pertinent instruction related to the patient’s care and treatments that the agency will provide, specific to the patient’s care needs would be provided to the patient and/or his/her caregiver and representative (if any) no later than the next visit after the plan of care (POC) has been approved by the physician. The written information should be updated as the POC changes. RECORD/PATIENT #1: Review of the resumption of care (after hospitalization) orders dated 08./09/2022, showed the physician ordered skilled nurse (SN) services twice a week to assist with wound care. Observation and interview during the patient’s home visit, on 08/30/2022 beginning at 1:55 PM, showed the patient’s admission folder failed to contain written wound care instructions for the patient/caregiver. The registered nurse (RN) stated that they have a form to fill out with wound care instructions. The RN found the form in the folder, but it had not been filled out.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on policy review, record review, home visit observation, and interview, the agency failed to ensure each patient received updated written information related to the visit schedule, in one (Record/Patient #1) of three home visit observations. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled, "Care Planning and Coordination: Written Information to the Patient," reviewed 03/2022, showed in part the visit schedule will be provided to the patient and/or caregiver and representative no later than the next visit after the plan of care (POC) has been approved by the physician. The written information should be updated as the POC changes. The visit schedule includes frequency of visits by agency personnel and personnel acting on behalf of the agency. RECORD/PATIENT #1: The POC dated 07/06/2022, showed the physician ordered skilled nursing (SN) services to be provided to the patient one time a week for one week then once every four weeks. Review of the resumption of care (after hospitalization) orders dated 08./09/2022, showed the physician ordered SN services twice a week to assist with wound care. Observation and interview during the patient’s home visit, on 08/30/2022 beginning at 1:55 PM, showed the patient’s admission folder failed to contain a current visit schedule. The last schedule was printed on 04/11/2022, with the last week being 05/01/2022 through 05/07/2022. The registered nurse (RN) could not find a more current calendar in the folder. The RN stated that they bring a new calendar every 60 days, and he/she brought a new visit schedule today. During an interview on 08/30/2022 beginning at 3:45 PM, the administrator stated that the staff were to take out a new schedule at recertification and resumption of care.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on policy review, record review, home visit observation, and interview, the agency failed to ensure each patient received updated written information related to the medication schedule, in one (Record/Patient #1) of three home visit observations. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled, "Care Planning and Coordination: Written Information to the Patient," reviewed 03/2022, showed in part the medication schedule will be provided to the patient and/or caregiver and representative no later than the next visit after the plan of care (POC) has been approved by the physician. The written information should be updated as the POC changes. The medication schedule/instructions includes the medication name, dosage and frequency and which medications will be administered by agency personnel and personnel acting on behalf of the agency. RECORD/PATIENT #1: Observation and interview during the patient’s home visit, on 08/30/2022 beginning at 1:55 PM, showed the patient’s admission folder failed to contain a current medication schedule. The last medication schedule was printed on 04/11/2022. The registered nurse (RN) could not find a more current medication schedule in the folder. The RN stated that he/she brought a current medication schedule today.

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 policy review, home visit observation, and interview, the agency failed to follow accepted standards of practice to prevent the transmission of infections and communicable diseases in three (Records/Patient’s #1, #2, and #7) of three home visit observations conducted. This deficient practice has the potential to affect the health and safety of all patients served by the agency. Findings included: Review of the agency’s policy titled, “Nursing Bag Technique,” dated/revised 02/2022, showed: - The nursing bag should never be placed on the floor; - Prior to administering care, the barrier is laid down on a flat surface and will have a designated clean and dirty side; and - Hands are washed prior to returning the clean equipment and supplies to the bag. Review of the agency’s policy titled, “Therapy and Aide Bag Technique,” dated/revised 05/2022, showed when the visit is completed, reusable equipment will be cleaned with alcohol pads or germicidal wipes, hands will be cleansed, and equipment and supplies will be returned to the bag. Review of the agency’s policy titled, “Infection Control Program,” dated/revised 11/28/2018, showed the home health agency staff must maintain clean equipment and supplies during the home visit for use in multiple patient’s homes. Review of the agency’s policy titled, “Hand Hygiene CDC (Centers for Disease Prevention and Control) Guidelines,” dated/revised 04/2019, showed hand hygiene should be performed: - After coming in contact with patient’s intact skin, i.e., taking a patient’s blood pressure, pulse, lifting/moving the patient; - After contact with medical equipment/supplies in patient areas; and - Always after removing gloves. Review of the agency’s policy titled, “Standard Precautions,” dated/revised 11/2018, showed: - Gloves do not take the place of hand hygiene; - Hands are to be washed after removing gloves; and - Gloves should be changed between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms. RECORD/PATIENT #2: Observations during a home visit on 08/30/2022 beginning at 9:00 AM showed the licensed practical nurse (LPN): - Placed a plastic barrier on the table; - Placed a clean rolled dressing on the barrier; - Picked up a bag of dressing supplies from the patient’s floor; and - Placed the bag from the floor onto the barrier next to the clean roll dressing and pulled more dressing supplies from the bag. Per an interview conducted immediately following the home visit, the LPN stated that he/she did not think about placing the bag onto the clean barrier. He/she should have placed the bag on a separate barrier. During an interview on 08/31/2022 at 9:00 AM, the administrator stated that he/she would expect the clinician to ensure a barrier was down before placing any items on a surface. There should be a designated clean and dirty section. The nurse should not have picked up anything off of the floor and placed it on the barrier containing the clean dressing supplies. RECORD/PATIENT #7: Observations during a home visit on 08/30/2022 beginning at 11:55 AM showed the physical therapy assistant (PTA): - Obtained vital signs and laid soiled vital signs equipment on a barrier; - Donned gloves to provide exercise treatment to the patient involving bed and chair transfers; - Failed to remove soiled gloves/perform hand hygiene before he/she cleaned the blood pressure equipment, thermometer, and gait belt; - Failed to remove the soiled gloves/perform hand hygiene before he/she placed the cleaned equipment back into his/her bag; - Asked the patient to use an alcohol based hand rub before the patient electronically signed the treatment acknowledgement screen on the PTA’s phone; and - Failed to remove soiled gloves/perform hand hygiene before he/she cleaned his/her phone with a cleaning wipe. Per an interview immediately following the home visit, the PTA stated that he/she could see how the failure to change gloves and perform hand hygiene would re-contaminate the cleaned equipment and contaminate the items in his/her treatment bag. He/she would clean the equipment in the bag before leaving for another visit. During an interview on 08/31/2022 at 9:00 AM, the administrator stated that the clinician should remove gloves and perform hand hygiene after any patient contact before going to any clean tasks. The clinician did not really need to wear gloves while performing treatment but since the clinician wore them, he/she would expect the clinician to change gloves and perform hand hygiene after patient contact before cleaning equipment and again before picking up cleaned equipment and placing it in their bag. Findings included: Review of the agency’s policy titled, “Nursing Bag Technique,” dated/revised 02/2022, showed: - The nursing bag should never be placed on the floor; - Prior to administering care, the barrier is laid down on a flat surface and will have a designated clean and dirty side; and - Hands are washed prior to returning the clean equipment and supplies to the bag. Review of the agency’s policy titled, “Therapy and Aide Bag Technique,” dated/revised 05/2022, showed when the visit is completed, reusable equipment will be cleaned with alcohol pads or germicidal wipes, hands will be cleansed, and equipment and supplies will be returned to the bag. Review of the agency’s policy titled, “Infection Control Program,” dated/revised 11/28/2018, showed the home health agency staff must maintain clean equipment and supplies during the home visit for use in multiple patient’s homes. Review of the agency’s policy titled, “Hand Hygiene CDC (Centers for Disease Prevention and Control) Guidelines,” dated/revised 04/2019, showed hand hygiene should be performed: - After coming in contact with patient’s intact skin, i.e., taking a patient’s blood pressure, pulse, lifting/moving the patient; - After contact with medical equipment/supplies in patient areas; and - Always after removing gloves. Review of the agency’s policy titled, “Standard Precautions,” dated/revised 11/2018, showed: - Gloves do not take the place of hand hygiene; - Hands are to be washed after removing gloves; and - Gloves should be changed between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms. RECORD/PATIENT #1: Observation on 08/30/2022 beginning at 1:55 PM, during the patient's home visit, showed the registered nurse (RN) touched the patient’s soiled incontinence pad then without removing his/her gloves or sanitizing his/her hands touched a package of gauze sponges and touched the Ziploc bag that contained his/her supply of gloves. The RN then removed his/her gloves and sanitized his/her hands. The RN then touched the soiled Ziploc bag to obtain another pair of gloves and touched the soiled package of gauze and proceeded to provide wound care for the patient. During an interview on 08/30/2022, beginning at 3:55 PM, the administrator stated that he/she would expect the nurse to change gloves and use hand sanitizer after touching anything soiled.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on policy review, review of employee vaccination records, and interview, the agency failed to develop and implement policies and procedures that include a process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19. This deficient practice has the potential to affect the health and safety of all patients served by the agency. Findings included: Review of the agency’s policy titled, “COVID-19 Vaccination Mandate Policy,” dated/revised/reviewed 04/21/2022 showed: - Employees granted an exemption may be subject to conditions or restrictions related to their job, facility access, and/or safety requirements (e.g. masking, additional PPE (personal protective equipment), testing; - Visiting Nurse Association (VNA) has created a contingency plan for staff members that are not fully vaccinated and do not qualify for an exemption; - Alternative accommodations may be transfer to programs not regulated by the Centers for Medicare and Medicaid Services (CMS) mandate or opportunities to work fully remote if applicable for the position; and - The agency policy failed to specifically define what additional measures were implemented for staff who are not fully vaccinated for COVID-19. During an interview on 08/29/2022 at 2:49 pm, the administrator stated the additional measures for unvaccinated/exempted staff included weekly testing, wearing masks at all times, and staff must wear N95 mask without the exhalation valve when visiting patients who have compromised immune systems. The policy language that stated the exempted employee may be asked to follow additional measures is vague and the agency follows the best practice guidelines outlined by the Centers for Disease Prevention and Control (CDC). He/she thought the policy referred to the best practices. On 08/30/2022 at 4:30 PM, the administrator presented the surveyors with a revised policy, dated/revised 08/29/2022, that included a statement that stated “See Healthcare Worker Best Practice for additional guidelines for employees who have received an exemption.”

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 policy review, record review, and interview the agency failed to provide services as directed by the physician ordered plan of care (POC) in one (Record/Patient #1) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency’s policy titled, “Coordination of Services,” reviewed 02/2022, showed in part, that care, treatment, and/or services are provided by the agency in an interdisciplinary, collaborative manner as appropriate to the needs of the patient and the agency’s scope of service. All agency personnel providing care, treatment and/or services to patients maintain liaison with other healthcare team members to ensure effective coordination of efforts and to support the goals and objectives outlined in the POC. RECORD/PATIENT #1: Review of the registered nurse (RN) recertification visit report dated 07/01/2022 showed: - Diagnoses that included congestive heart failure (CHF, a chronic condition where the heart does not pump blood as well as it should); - Bedfast, unable to be ambulate or be up in a chair, unable to transfer and unable to turn and position self; and - No documentation of weight or abdominal girth measurement. Review of the recertification POC dated 07/06/2022, showed an order for the skilled nurse (SN) to assess for signs and symptoms of CHF to identify changes associated with exacerbation of illness for early interventions of complications. SN to weigh patient every visit and report to the physician a weight gain of three pounds or more within the last 24 hours and/or five pounds within a week. If unable to weigh patient, perform abdominal girth measurements. Review of the SN visit note reports showed: - On 07/13/2022, the nurse instructed to keep a daily weight log and call the SN for a weight gain of two to three pounds in a day or five pounds in a week. The SN failed to document the patient’s current weight or abdominal girth measurement; and - On 07/20/2022 the nurse documented he/she assessed for signs and symptoms of CHF including an increase in weight of three pounds in one day or since the last visit but failed to document the patient’s current weight or abdominal girth measurement. Review of the resumption of care (after hospitalization) nursing visit report dated 08/09/2022, showed: - Diagnoses that included CHF; and - Weight 165 pounds (unsure how this was obtained or whether it was obtained at the hospital). Review of the resumption of care physician orders dated 08/09/2022, showed an order for the SN to assess for signs and symptoms of CHF to identify changes associated with exacerbation of illness for early interventions of complications. SN to weigh patient every visit and report to the physician a weight gain of three pounds or more within the last 24 hours and/or five pounds within a week. If unable to weigh patient, perform abdominal girth measurements. Review of the nursing visit note reports dated 8/10/2022 through 08/25/2022 showed the SN documented he/she assessed for signs and symptoms of CHF including an increase in weight of three pounds in one day or since the last visit but failed to document the patient’s current weights or abdominal girth measurements. During an interview on 08/30/2022, beginning at 3:45 PM, the administrator stated that weights or abdominal girth measurements should be recorded in the vital sign section of the visit notes. He/she would look for documentation. During an interview on 08/31/2022 beginning at 9:35 AM, the administrator stated that he/she could not find documentation of weights or abdominal girth measurements.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on policy review, clinical record review, and interview, the agency failed to ensure the accuracy of clinical records to include all interventions, including medication administration, treatments, and services, and responses to those interventions in, but not limited to, two (Records/Patients #2 and #3) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency’s policy titled, “Content of the Clinical Record,” dated/revised 02/2021, showed the clinical record will contain sufficient information to accurately document care, treatment and/or services provided and results in detail to facilitate continuity of care. RECORD/PATIENT #2: Review of the plan of care (POC) dated 08/01/2022 through 09/29/2022 showed: - Skilled nurse (SN) to weigh patient every visit; - Report a weight gain of three pounds or more within the last 24 hours and/or five pounds or more within a week; and - If unable to weigh patient, perform abdominal girth measurement. Review of SN notes dated 08/04/2022, 08/11/2022, and 08/27/2022 showed: - A note that stated that the patient was weighed and the weight was recorded within the vital signs section (VS); and - The visit notes failed to contain documentation of the patient's weight. Review of the physical therapy (PT) notes dated 07/29/2022 and 08/10/2022 showed: - A note that stated that the patient was weighed and the weight was recorded within the VS section; and - The visit notes failed to contain documentaion of the patient's weight. Review of the physical therapy (PT) notes dated 08/17/2022 and 08/24/2022 showed: - A note that stated that the clinician was unable to weigh patient and the abdominal girth measurement was recorded within the VS section; and - The visit notes failed to contain documentation of the abdominal girth measurement. Review of the physical therapy assistant (PTA) note dated 08/02/2022 showed: - A note that stated that the clinician was unable to weigh patient and the abdominal girth measurement was recorded within the VS section; and - The visit note failed to contain documentation of the abdominal girth measurement. RECORD/PATIENT #3: Review of the PTA note dated 08/02/2022 showed: - The patient was assessed for pain and reported pain; - The pain measurement was recorded in the VS section; and - The visit note failed to contain documentation of the pain measurement. During an interview on 08/31/2022 at 9:00 AM, the administrator stated that the incorrect entries are a result of the clinicians not reading the interventions thoroughly and just swiping through without taking the time to make the entry specific for the patient. He/she could see how entering that they performed weights, measurements, and pain and recorded it in the vitals would be inaccurate clinical documentation.