Every finding on record at Vita L.L.C.

An extended survey for Medicare certification for Vita LLC was completed on 01/11/2022. The agency had 35 current patients. One condition-level deficiency was identified at an immediate jeopardy (IJ) level as follows: 484.60 Condition of Participation: Care Planning, Coordination of Services, and Quality of Care. An immediate jeopardy level for likelihood of harm to one patient (Patient #1), and likelihood for future harm to other patients was identified during the survey. The findings were confirmed as immediate jeopardy by the Centers for Medicare and Medicaid Services (CMS). On 01/06/2022, the administrator was informed verbally and in writing via the IJ Template, of the findings identified at an immediate jeopardy level. A formal written removal plan was submitted by the agency on 01/10/2022. This removal plan was reviewed by the state agency (SA) in conjunction with CMS and it was determined at the time of the survey exit on 01/11/2022, that a satisfactory removal plan had been initiated related to the immediate jeopardy findings. The condition level deficiency identified above remains as cited. An additional condition-level deficiency was identified and cited: - §484.105 Condition of Participation: Organization and administration of Services A home health agency that is found out of compliance with any Condition of Participation evaluated as part of a standard survey may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. A deficiency has been cited at §484.80(f)(3) – see Tag G788. A COVID-19 Focused Infection Control survey was also completed on 01/11/2022. One standard level deficiency was identified related to the Infection Control survey. The Emergency Preparedness regulations were reviewed as part of the Medicare certification survey completed on 01/11/2022. One standard level deficiency was identified.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on record review, observation, and interview, the agency failed to ensure that individual plans for each patient were included as part of the comprehensive patient assessment in one (Record/Patient #3) of six records reviewed. This deficient practice has the potential to adversely affect patient safety in the event of an emergency for all the agency's patients. Findings included: RECORD/PATIENT #3: Review of the "Individual Patient Emergency Preparedness Plan" form in the clinical record failed to show relevant healthcare information. This area was left blank and failed to show an emergency plan. Observation on 12/29/2021 at 12:30 PM, during the patient's home visit, showed the copy of the "Individual Patient Emergency Preparedness Plan" form, found in the patient's home folder, was not complete (failed to show an emergency plan). On 12/29/2021 at 1:45 PM, the administrator and the director of patient care, agreed that the plan was not complete and should have been completed.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on record review, observation, and interview, the agency failed to provide the patient with written information of the charges for services that may not be covered and the charges the patient may be expected to make to the agency in one (Record/Patient #3) of six records reviewed. This deficient practice has the potential to affect the patient's understanding of their financial liability and cause financial hardship for all the agency's patients. Findings included: Review of the agency's undated policy titled, "Patient Bill of Rights and Responsibilities," showed the patient will be advised of the charges the individual may have to pay before care is initiated. The policy failed to show that written notice was required. RECORD/PATIENT #3: Review of the agency's form titled, "Admission Service Agreement," signed by the patient on 12/14/2021 showed the following: - The box was checked for insurance coverage; - Projected amount of charges to be covered after deductible met was blank; and - Specify amount area was left blank. Observation on 12/29/2021 at 12:30 PM, during the patient's home visit, showed the patient's home folder failed to contain written patient specific financial liability information. During an interview on 12/29/2021 at 1:50 PM, the director of patient care stated that the blanks on the consent form for financial liability should be filled in, if it is known.

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 conduct the initial assessment of the patient within 48 hours of the referral to home care, or on the physician ordered start of care date in two (Records/Patients #1 and #3) of five records reviewed. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #3: Review of the clinical record showed a history and physical from a recent hospital stay with the date of admission 11/23/2021 and the discharge date of 11/29/2021. The patient was admitted for upper extremity (arm) weakness, left elbow bursitis (Inflammation of the elbow bursa, a bursa is a closed, fluid-filled sac that works as a cushion and gliding surface to reduce friction between tissues of the body), and infection of the left elbow bursa with sepsis (a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues). The patient went home with a paid caregiver and family member's assistance. Review of a referral from the hospital dated 11/29/2021 and printed 12/04/2021 showed an order for home assistance for PT (physical therapy) and OT (occupational therapy) to evaluate and treat. Review of an email dated 12/04/2021 sent to the agency from the hospital showed the referral was received from the hospital on Saturday 12/04/2021. Review of an authorization notification form from the insurance company showed the date of authorization as 12/06/2021 and the date that home health was approved to start care was 12/07/2021. During an interview on 12/29/2021 at 1:30 PM, the office manager stated that: - There was a delay in the start of care (SOC) due to problems with getting the insurance authorization; - Originally, the referral must have gone to another agency because they did not receive it until Saturday, 12/04/2021; and - There is not office staff working on the weekend and the referral was found on Monday, 12/06/2021. Review of a physician order dated 12/08/2021 showed, "Per patient request Start of Care scheduled on 12/14/2021. MD notified and agreed." Review of the clinical record failed to show communication with the patient or the physician. The start of care visit was completed on 12/14/2021. According to the physician order, the physician was not contacted until 12/08/2021, four days after the referral was sent to the agency which delayed the start of care further and the order was not received until greater than 48 hours after the referral. The agency failed to complete the start of care within 48 hours of the referral. The patient failed to receive home health services for 14 days after the discharge from the hospital. On 12/29/2021 at 1:45 PM, the administrator and director of patient care both stated that insurance authorization is a problem and they sometimes have to delay the initial assessment visit waiting on the authorization or they will not get paid. Findings included: Review of the agency's policy titled "Initial Assessment/Comprehensive Assessments" dated October 2017 showed: - A registered nurse (RN), physical therapist (PT) must conduct the initial assessment visit within 48 hours of referral, within 48 hours of the patient’s return home or on the physician-ordered start of care date; - The initial assessment visit is conducted to determine the immediate care and support needs of the patient; - In the absence of a physician-specified start of care date, the initial assessment visit is conducted within 48 hours of the referral; and - If the physician specified a start of care date, this supersedes the 48-hour timeframe. RECORD/PATIENT #1: Review of the referral information faxed to the home health agency on 12/10/2021 showed a referral for physical therapy and occupational therapy to evaluate and treat. Review of the clinical record showed physical therapy evaluation dated 12/13/2021 (three days after the referral for home health). During an interview on 12/28/2021 at 1:30 PM, the administrator and director of patient care stated the following: - The agency receives a referral, the physician orders are received, and the agency opens the case within 24 to 48 hours; and - They have had issues with the initial visit and insurance has denied payment so they wait to get insurance authorization prior to making the initial visit.

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 interviews, the agency failed to ensure the patient's medications were reconciled during the start of care comprehensive assessment and that the medication profile was updated with medication changes in, three (Records/Patients #1, #2 and #3) of five full records reviewed. This deficient practice has the potential affect the accuracy and safety of medication administration for all the agency's patients. RECORD/PATIENT #3: Review of the clinical record showed a history and physical from a recent hospital stay with the date of admission 11/23/2021 and the discharge date of 11/29/2021. The patient was admitted for upper extremity (arm) weakness, left elbow bursitis (Inflammation of the elbow bursa, a bursa is a closed, fluid-filled sac that works as a cushion and gliding surface to reduce friction between tissues of the body), and infection of the left elbow bursa with sepsis (a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues). The patient went home with a paid caregiver and family member's assistance. Review of the hospital current discharge medication list dated 11/29/2021 compared to the start of care agency medication profile dated 12/14/2021 showed the following discrepancies: - The medication profile failed to show prednisone (a corticosteroid that prevents the release of substances in the body that cause inflammation) 20 mg (milligrams) orally two tablets at breakfast daily; - The medication profile showed acetaminophen (a mild pain and fever reliever) 325 mg every four hours as needed and the hospital discharge medication list showed acetaminophen 650mg; - The hospital current discharge medication list showed oxycodone/acetaminophen 10/325 mg ½ to one tablet orally every 6 hours as needed. The agency medication profile failed to show this medication; and - The agency medication profile showed diclofenac sodium 1% gel (used to relieve joint pain from arthritis and belongs to a class of drugs known as (NSAIDs) nonsteroidal anti-inflammatory drugs) apply to affected area but failed show the area of use and the frequency to be applied. During a home visit observation on 12/29/2021 at 12:30 PM, the patient confirmed his/her current medications. The medication profile failed to show the following medications: - Prednisone 20 mg one tablet orally every day (this was filled on 12/21/2021); - Oxycodone/acetaminophen 10/325 mg one tablet orally 2x per day for severe pain; - Turmeric 500 mg orally one tablet daily; - Vitamin C 500 mg orally daily; - Glucosamine chondroitin one tablet orally daily; - Acidophilus probiotic 100 million organisms one tablet daily; and - Ibuprofen 200 mg orally two tablets every 4 hours as needed. On 12/29/2021 at 1:50 PM, the administrator and director of patient care both agreed the medication review by the staff could be better. The director of patient care stated that medication management was not the focus of a PT and OT referral. Findings included: Review of the agency's policy titled, "Medication Reconciliation," dated October 2017 showed, in part, the following: - At time of admission, the admitting registered nurse, physical therapist will create and document a list of medications that the patient is taking at home, including dose, strength , route, and frequency; - The medication ordered while the patient is receiving care will be compared to the medication list/profile; and - The medication list/profile will be updated with each new or changed medication and the patient’s medication list in the home will be updated. RECORD/PATIENT #1: Review of the current Medication Profile dated on 12/13/2021 through 02/10/2022 showed: - Amlodipine (treats high blood pressure and chest pain) 2.5-milligram (mg) oral tablet one daily by mouth; - Vitamin D3 1000 international units (25 microgram) oral tablet one tablet daily by mouth; - Menthol with zinc topical cream, one application two times per day to effected area; and - Miconazole 2% topical gel (antifungal medication), one application twice per day to effected layer “By mouth”. During an observation and interview during the home visit on 12/28/2021 at 12:00 PM, showed the following: - The occupational therapist said the patient’s family member takes care of the patient’s medication and did not reconcile the patient’s medications; - The patient’s prescription bottle filled on 10/22/2021 showed amlodipine 5 mg one tablet daily by mouth; - The patient’s family member said the patient did not take Vitamin D3; and - The patient did not use Menthol with zinc topical cream and miconazole topical gel. RECORD/PATIENT #2: Review of the patient’s medical record showed the patient did not take medication. During an observation and interview during the home visit on 12/29/2021 at 9:30 AM, showed the following: - The patient had a bottle of Tylenol extra strength 500 mg, Aspercreme with Lidocaine 4% (relieves itching and pain), and Fast Freeze (all natural cooling pain relief therapy) sitting on his/her dresser; - The patient said he/she took Tylenol extra strength 500 mg one tablet every six hours as needed for neck pain; - The patient said he/she used Aspercreme with Lidocaine as needed for knee pain; - A nurse had used Fast Freeze when his/her neck hurt; and - Tylenol extra strength, Aspercreme with Lidocaine, and Fast Freeze was not in the patient’s medical record. During an interview on 12/28/2021 at 12:00 PM registered nurse, (RN) A stated patient #2 did not take any medication. During an interview on 12/28/2021 at 1:30 PM, the administrator stated all therapist ask if the patient has any new medication; if the patient has changes in medication; the therapist calls the nurse and the nurse will write an order and sends it to the physician. If the patient’s care involves skilled nursing, the skilled nurse reconciles medication each week by comparing medication bottles to the medication list.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on policy review, record review, observation, and interview, the agency failed to: - Include all the required elements of an individualized plan of care (G574); - Include all patient care orders, including verbal orders, in the plan of care (G576); - Provide conformance with physician orders (G578); - Administer drugs, services, and treatments only as ordered by the physician (G580); - Promptly alert the physician or allowed practitioner to any changes in the patient’s condition or needs (G590); - Coordinate care delivery to meet the patient’s needs (G608); and - Provide the name and contact information of the home health agency’s clinical manager (G622). The cumulative effect of these deficient practices has the potential to affect the provision of safe care for all patients served by the agency.

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 include all the required elements of an individualized plan of care in, but not limited to, two (Records/Patients #1 and #4) of five full records reviewed. This deficient practice has the potential to adversely affect the care provided to all the agency’s patients. Findings included: RECORD/PATIENT #4: Review of the clinical record showed that the patient was admitted to the agency for wound care on 04/14/2021. The patient lives in his/her own home with his/her adult children. Review of the referring physicians orders, dated 04/13/2021, showed the patient had the following diagnoses: - Sacro-coccygeal (area near the tailbone) wound; - Hypertensive cardiovascular disease, (HCVD) (heart conditions caused by high blood pressure); - Coronary artery disease (CAD) (a narrowing or blockage of the major arteries of the heart); and - Hypothyroidism (underactive thyroid). Nursing assessments dated 10/19/2021 through 12/21/2021 identified the patient had dyspnea (shortness of breath), diminished breath sounds (reduced air flow to part of the lungs), activity intolerance, and fatigue/weakness. Review of the medication profile dated, 12/10/2021, showed: - The patient takes sotalol (a medication used to treat conditions that cause irregular heartbeat) 80 milligrams (mg) by mouth twice a day, and levothyroxine (a medication used to treat an underactive thyroid gland) 75 micrograms (mcg) by mouth daily; and - The sotalol dosage was increased from one half tablet twice daily to one tablet twice daily on 06/29/2021. Review of the plans of care dated, 06/13/2021, 08/12/2021, 10/11/2021, and 12/10/2021 showed the agency failed to include the diagnoses of HCVD, CAD, and hypothyroidism and failed to include patient specific interventions related to the diagnoses of HCVD, CAD and hypothyroidism. During an interview with the administrator on 12/29/2021 at 1:10 PM, the administrator stated that he/she was told by Centers for Medicare Services (CMS) that he/she couldn’t use the other medical diagnoses on the Outcome and Assessment Information Set (OASIS) and the OASIS is used to generate the plan of care but he/she understood why all of the pertinent diagnoses should be listed on the plan of care. Review of the agency’s policy titled, “Plan of Care –CMS #485 and Physician Orders,” revised 10/2017, showed the individualized plan of care must include: - All pertinent diagnoses; and - Patient-specific interventions and education. RECORD/PATIENT #1: The comprehensive assessment dated 12/13/2021 at 9:15 AM showed: - Selections will populate in plan of care bleeding precautions and diabetic, do not cut nails; - Diabetes, blood sugars performed by patient, random blood sugar range from 80 to 300 (normal 80 milligram (mg)/deciliter (dl) to 130 mg/dl) and insulin administered by caregiver; and - Urinary tract infection in last 14 days. Review of the PT evaluation dated 12/13/2021 at 9:15 AM showed the patient had a pain level of six in both lower extremities, increased by walking and activities of daily living, and relieved by rest and reposition. Review of the POC dated 12/13/2021 through 02/10/2022 showed: - Diagnoses included: Hemiplegia (muscle weakness or partial paralysis on one side of the body) following cerebral infarction (stroke), type 2 diabetes mellitus (chronic condition that affects the way the body processes blood sugar) with diabetic nephropathy (diabetic kidney disease), and acute or congestive heart failure (CHF) (chronic condition in which the heart doesn’t pump blood as well as it should); - Durable medical equipment included but not limited to a walker and grab bars but failed to include medical equipment/supplies for blood glucose (sugar) monitoring; - The POC failed to include when to check the blood glucose and how often, parameters for blood glucose levels, and when to notify the physician of abnormal results. Safety showed diabetic: do not cut nails; - The POC failed to include specific interventions for monitoring and education of bleeding precautions. The plan of care showed under safety, bleeding precautions due to anticoagulation therapy (medicine that helps prevent blood clots); - Physical therapy to minimize/eliminate risk for hospitalization due to high-risk principal diagnosis, CHF but the POC failed to include specific interventions for monitoring and education of CHF; - The plan of care failed to include pain parameters; and - The plan of care failed to include specific interventions for assessing and education of urinary tract infections. During an observation and interview during the home visit on 12/28/2021 at 12:00 PM showed the following: - The patient’s back hurts every day and rates it a five or six due to his/her tailbone deteriorating; - The patient rated his/her chest pain a nine; - The patient had swollen feet and ankles; - The patient refused to take a diuretic for the fluid in his/her chest because the diuretic caused him/her to urinate frequently; - OT A talked with the patient and the patient said the physician told him/her the pain in his/her chest was due to CHF; - The patient family member checked the patient’s blood glucose every morning and today the fasting blood sugar was 150; and - OT A said the physical therapist is responsible for the POC since he/she did the start of care assessment. During an interview on 12/28/2021 at 1:30 PM, the clinical director of patient care stated staff should follow the POC, pain parameters should be on the POC and the skilled nurse would check blood sugars. There was no additional information provided.

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 policy review, record review, and interview, the agency failed to ensure all patient care orders, including verbal orders, were recorded on the plan of care in one (Record/Patient #5) of six record reviews. This deficient practice has the potential to affect the accuracy of care provided to all the agency's patients. Findings included: Review of the agency's undated policy titled, "Plan of Care - CMS #485 and Physician Orders," showed all patient care orders, including verbal orders, must be recorded in the plan of care. RECORD/PATIENT #5: Review of the referral information showed the patient was admitted to home health services for left great toe/left lower extremity (leg) cellulitis(infection of the skin) with sepsis (a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues), left foot infection, and congestive heart failure. He/she was admitted to services on 10/21/2021 for skilled nurse wound care, physical therapy (PT), and occupational therapy (OT). Review of the skilled nurse visit notes dated 11/10/2021 showed RN A documented that an order was received to remove sutures. Documentation showed registered nurse (RN) A removed sutures at the posterior (back) of the great toe. Review of the clinical record failed to show an order for the sutures to be removed. During an interview on 12/29/2021 at 2:00 PM, the administrator stated they would look for an order. The office manager came back later and stated he/she was unable to find an order for suture removal.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on policy review, record review, and interview, the agency failed to conform with physician orders when the treatments documented did not follow the orders on the plan of care (POC) in two (Records/Patients #2 and #5) of five records reviewed. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #5: Review of the referral information showed the patient was admitted to home health services for left great toe/left lower extremity (leg) cellulitis(infection of the skin) with sepsis (a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues), left foot infection, and congestive heart failure. He/she was admitted to services on 10/21/2021 for skilled nurse wound care, physical therapy (PT), and occupational therapy (OT). Review of the plan of care dated 10/21/2021 to 12/19/2021 showed incomplete wound care orders for the left lower extremity wound. The order failed to show a frequency for the wound care. Review of the referral discharge from hospital instructions showed wound care to be completed every other day. Skilled nurse visits are being completed on Monday, Wednesday, and Friday every week and wound care is completed each time. Review of the clinical record failed to show communication with the physician to change the wound care frequency from every other day to three times per week and the order failed to show a frequency. During an interview on 10/29/2021 at 1:05 PM, the administrator stated the wound care order should show a frequency for the dressing changes. Findings included: Review of the agency policy titled, "Plan of Care- CMS #485 and Physician Orders," dated October 2017, showed in part: -Care and services provided will be provided according to physician orders; and - Drugs, services and treatments shall be administered as ordered by the physician. RECORD/PATIENT #2: Review of the plan of care dated 09/16/2021 showed: - Diagnosis included a stage 4 pressure ulcer (full thickness tissue loss) of the left hip; - Skilled nurse to perform pressure ulcer care to left hip Monday, Wednesday and Friday; and - Cleanse wound with wound cleanser, pack with Calcium Alginate AG (silver) (dressing), cover with 4x4 (gauze) and ABD (gauze) and secure with tape and using aseptic technique (standard technique to prevent the transfer of germ to or from an open wound). Review of the physician order dated 11/10/2021 showed a new order to alternate every two weeks with Calcium Alginate AG with Calcium Alginate plain. Review of the skilled nurse (SN) visits showed: - On 11/10/2021, 11/12/2021 and 11/15/2021 the SN packed the wound with Calcium Alginate AG; - On 11/17/2021, the SN packed the wound with one strip of Calcium Alginate; - On 11/19/2021 through 12/13/2021, the SN packed the wound with Calcium Alginate AG; - On 12/15/2021, the SN packed the wound with one strip of Calcium Alginate and documented “new order to alternate every two weeks with Calcium Alginate AG with Calcium Alginate plain”, (the physician order was dated 11/10/2021); - On 12/17/20212021 through 12/24/2021, the SN packed the wound with Calcium Alginate AG; and - The skilled nurse failed to alternate Calcium Alginate AG with Calcium Alginate every other week as ordered by the physician. During an observation and interview during the home visit on 12/29/2021 at 9:30 AM, showed the following: - Registered nurse (RN) A cleansed the wound with wound cleanser, gently patted dry, triad hydrophilic wound dressing paste applied to peri wound area, wound is packed with Calcium Alginate AG, covered with folded gauze and taped; - RN A stated he/she spoke to the licensed practical nurse (LPN) prior to visit to find out what dressing change was scheduled since there was orders to alternate dressing changes; and - The SN must have documented the dressing changes wrong because he/she has been alternating Calcium Alginate AG with Calcium Alginate plain every other week. During an interview on 12/28/2021 at 2:28 PM, the administrator said the SN must have documented the treatments incorrectly because the SN changed the treatments every other week per the physician orders. There was no further information provided.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review, observation, and interview the agency failed to ensure staff obtained physician orders for medication and treatments which affected one (Record/Patient #2) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: RECORD/PATIENT #2: Review of the plan of care dated 11/12/2021 to 01/10/2022 showed: - Diagnosis included a stage 4 pressure ulcer (full thickness tissue loss) of the left hip and hypertensive chronic kidney disease; and - There was no medication listed. Review of the skilled nurse notes showed on 12/15/2021, the patient had neck pain rated a 2 (using a pain scale of zero to 10, zero which is no pain, to 10 the worst pain possible), the pain was aching and throbbing, pain was relieved by heat, massage, and medication (the medication used was not listed). There was no physician order for heat, massage and medication. Observation on 12/29/2021 at 9:30 AM, during the patient's home visit, showed the patient had a bottle of Tylenol extra strength (medication to reduce pain and fever) 500 milligrams (mg), Aspercreme with Lidocaine 4% (relieves itching and pain), and Fast Freeze (all natural cooling pain relief therapy) sitting on his/her dresser. Per interview conducted during observation, the patient stated that: - They took Tylenol extra strength 500 mg one tablet every six hours as needed for neck pain; - They used Aspercreme with Lidocaine as needed for knee pain; and - A nurse had used Fast Freeze when his/her neck hurt. Record review showed Tylenol extra strength, Aspercreme with Lidocaine, and Fast Freeze was not in the patient’s medical record. During an interview on 12/29/2021 at 9:30 AM, registered nurse (RN) A stated that he/he was unaware the patient used Tylenol extra strength, Aspercreme with Lidocaine and Fast Freeze. During an interview on 12/29/2021 at 2:20 PM, the administrator stated that he/she would expect physician orders for medication and treatments.

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, observation, and interview, the agency failed to promptly alert the physician to changes in the patient's condition that may suggest a need to alter the plan of care (POC) in two (Records/Patients #1 and #5) of five records reviewed. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #3: Review of the clinical record showed a history and physical from a recent hospital stay with the date of admission 11/23/2021 and the discharge date of 11/29/2021. The patient was admitted for upper extremity (arm) weakness, left elbow bursitis (Inflammation of the elbow bursa, a bursa is a closed, fluid-filled sac that works as a cushion and gliding surface to reduce friction between tissues of the body), and infection of the left elbow bursa with sepsis (a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues). The patient went home with a paid caregiver and family member's assistance. Review of the occupational and physical therapist (OT and PT) notes from 12/14/2021 through 12/21/2021 showed the patient's pain rated a "4" or "5" on a zero to ten scale (zero being no pain up to 10 being the worst pain). Then on PTA C (physical therapist assistant C) visits dated 12/23/2021 and 12/24/2021, the patient's pain was rated at "7". Interventions on both visits showed medications, rest, and OT to address. The pain is in the left elbow and shoulder. The assessment failed to show what medications the patient was taking for the pain or how often. The visit notes failed to show the physician, OT, or clinical manager was contacted regarding the increase in pain. Findings included: Review of the agency policy titled, "Plan of Care- CMS #485 and Physician Orders," dated October 2017, showed in part: - The individualized plan of care must be reviewed and revised by the physician who is responsible for the home health plan of care and the agency as frequently as the patient’s condition or needs require; and - The agency must promptly alert the relevant physician(s) to any changes in the patient’s condition or needs that suggest the outcomes are not being achieved and/or that the plan of care should be altered. RECORD/PATIENT #1; Review of the POC dated 12/13/2021 through 02/10/2022, showed, in part: - The patient was admitted to home health services on 12/13/2021; - Physical therapy two times a week for four weeks and occupational therapy to evaluate; and - Diagnoses included: Hemiplegia (paralysis on one side of they) following cerebral infarction (stroke) affecting left non dominate side, type 2 diabetes mellitus (chronic condition that affects the way the body processes blood sugar) with diabetic nephropathy (diabetic kidney disease), acute or chronic diastolic (congestive) heart failure (chronic condition in which the heart doesn’t pump blood as well as it should), and Parkinson’s disease (disorder of the central nervous system that affects movement, often including tremors). Review of the occupational therapy (OT) evaluation on 12/14/2021 at 3:49 PM showed: - The patient had chest pain at a level nine (a scale used to rate pain, zero which is no pain to 10 which is the worst pain possible), increased by movement and relieved by Tylenol; and - The agency notified the physician and agreed with the plan of care, frequency and duration (the OT plan of care did not include any information regarding chest pain). The agency failed to notify the physician of the patient’s chest pain. Review of the OT visit note dated 12/18/2021 at 1:00 PM showed the following: - Subjective: The doctor reported that the patient had a diagnosis of congestive heart failure (CHF) with fluid around the heart; - The patient’s pain was affecting function; - The patient had chest pain and rated a 9 and relieved by Tylenol; and - The patient reports that he/she continues to have pain in chest with movement. The agency failed to notify the physician of the patient’s chest pain. Review of the occupational therapy assistant (OTA) visit note dated 12/21/2021 at 1:00 PM showed the following: - The patient complained of nausea and vomiting this morning and declined bathing and dressing; - Pain affecting function; - Patient complained of nine out of ten stomach pain, however, did not display signs/symptoms of pain at the level, increased by taking deep breaths and relieved by lying down; and - Refused bathing and dressing activities due to nausea. The agency failed to notify the physician of the patient’s nausea and vomiting, and stomach pain. Review of the OT visit note dated 12/24/2021 at 1:35 PM showed the following: - Subjective: Patient reports pain remains in chest where he/she has been diagnosed with CHF with fluid accumulation around heart contributing to pain in the chest; - Pain affects function; - Chest pain rated a nine, increased by movement and relieved by rest; and - The patient continues to report pain in chest with no relief where doctor has identified a diagnosis of CHF with fluid around heart. The agency failed to notify the physician of the patient’s chest pain During an observation and interview during the home visit on 12/28/2021 at 12:00 PM showed the following: - The patient rated his/her chest pain a 9 and his/her ankles and feet were swollen; and - OT A stated the patient said the physician told him/her the pain in his/her chest was due to CHF and he/she had not notified the physician of chest pain. During an interview on 12/28/2021 at 1:30 PM, the director of patient care stated if the patient is having clinical issues the staff should contact him/her and/or the physician. During an interview on 12/28/2021 at 1:30 PM, the administrator stated the staff should have reported the patient’s chest pain to the registered nurse and physician.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on policy review, review of job description, record review, and interview, the agency failed to ensure the coordination of care delivery to meet the patient's needs in two (Records/Patients #1 and #3) of five records reviewed. This deficient practice has the potential to affect the coordination of care and services for all patients on service with the agency. RECORD/PATIENT #3: Review of the clinical record showed a history and physical from a recent hospital stay with the date of admission 11/23/2021 and the discharge date of 11/29/2021. The patient was admitted for upper extremity (arm) weakness, left elbow bursitis (Inflammation of the elbow bursa, a bursa is a closed, fluid-filled sac that works as a cushion and gliding surface to reduce friction between tissues of the body), and infection of the left elbow bursa with sepsis (a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues). The patient went home with a paid caregiver and family member's assistance. Review of the occupational and physical therapist (OT and PT) notes from 12/14/2021 through 12/21/2021 showed the patient's pain was rated at "4" or "5" on a zero to ten scale (zero being no pain up to 10 being the worst pain). Then on PTA C (physical therapist assistant C) visits dated 12/23/2021 and 12/24/2021, the patient's pain was rated at "7". Interventions on both visits showed medications, rest, and OT to address. The pain is in the left elbow and shoulder. The assessment failed to show what medications the patient was taking for the pain or how often. The visit notes failed to show the supervising physical therapist or occupational therapist was contacted regarding the increase in pain. On the home visit observation dated 12/29/2021 at 12:30 PM with PTA C, the patient rated his/her pain at a "6" and had facial grimacing with therapy exercises. The patient stated he/she took the oxycodone with acetaminophen two times per day, every day and took acetaminophen and ibuprofen for breakthrough pain. The patient stated he goes to a pain specialist for chronic pain related to rheumatoid arthritis (an auto-immune form of arthritis that causes pain, swelling, stiffness and loss of function in the joints). The oxycodone with acetaminophen and the ibuprofen failed to be on the agency's medication profile and PTA C failed to notify a supervisor of the patient's increased pain. Findings included: Review of the agency policy titled, "Coordination of Patient Care," dated October 2017, showed in part: - Agency staff members regularly communicate to ensure that their efforts are coordinated effectively and ultimately support the objectives outlined in the plan of care; - To ensure that quality services provided to patients; - The agency must assure communication with all physicians involved in the plan of care; - Integrate services , whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination provided by all disciplines; - The director of clinical services provides oversight of all patient care services and oversight includes: * Coordinating patient care; *Ensuring the patients’ needs continually assessed; *Ensuring the development, implementation and updates of the individualized plan of care; - The director of clinical services and/or nursing supervisor communicates with staff daily to discuss changes in the patient’s condition, the plan of care and the physician’s orders; and - Staff provide the physician with patient information on an ongoing basis regarding current condition and changes in condition and outcomes of care and services. Review of the agency policy titled, "Job Description, Director of Clinical Services/Clinical Manager," dated October 2017, showed in part: - The director of clinical services/clinical manager is a registered nurse (RN) who supervises home health services to homebound patients in their place of residence in accordance with the attending physician orders and plan of care and strives to provide the highest quality of care; - Coordinates patient care; - Assures ongoing assessment of patient/family needs and implementation of interdisciplinary team plan of care; - Plans and supervises the agency; - Ensures compliance with federal, state, accrediting bodies, local and agency policies; and - Assures implementation of the patients’ plan of care in all patient care aspects of the agency. RECORD/PATIENT #1: Review of the start of care assessment dated 12/13/2021 at 9:15 AM, completed by physical therapy, showed there was no gastrointestinal issues and no pain that interferes with activity or movement. Review of the PT evaluation dated 12/13/2021 at 9:15 AM showed the patient had a pain level of six in both lower extremities, increased by walking and activities of daily living, and relieved by rest and reposition. Review of the POC dated 12/13/2021 through 02/10/2022, showed in part: - The patient admitted to home health services on 12/13/2021; - Diagnoses included: Hemiplegia (paralysis on one side of they) following cerebral infarction (stroke) affecting left non dominate side, type 2 diabetes mellitus (chronic condition that affects the way the body processes blood sugar) with diabetic nephropathy (diabetic kidney disease), acute or chronic diastolic (congestive) heart failure (chronic condition in which the heart doesn’t pump blood as well as it should), and Parkinson’s disease (disorder of the central nervous system that affects movement, often including tremors); and - Physical therapy two times a week for four weeks and occupational therapy to evaluate. Review of the occupational therapy (OT) evaluation on 12/14/2021 at 3:49 PM showed the following: - The patient had chest pain at a level nine (a pain scale used to rate pain, zero which is no pain to 10 which is the worst pain possible), increased by movement and relieved by Tylenol; and - The patient reports that he/she continues to have pain in chest with movement. The documentation failed to include coordination with the clinical manager, physical therapist and physician. Review of the OT visit note dated 12/18/2021 at 1:00 PM showed the following: - Subjective: The doctor reported that the patient had a diagnosis of congestive heart failure (CHF) with fluid around the heart; - The patient’s pain was affecting function; - The patient had chest pain rated a 9 and relieved by Tylenol; and - The patient reports continued pain in his/her chest with movement. The documentation failed to include coordination with the clinical manager, physical therapist and physician. Review of the occupational therapy assistant (OTA) visit note dated 12/21/2021 at 1:00 PM showed the following: - The patient complained of nausea and vomiting this morning and declined bathing and dressing; - Pain affecting function; - Patient complained of nine out of ten stomach pain, however, did not display signs/symptoms of pain at the level, increased by taking deep breaths and relieved by lying down; - Refused bathing and dressing activities due to nausea; and - No further reasons for stomach pain, nausea and vomiting. The documentation failed to include coordination with the clinical manager, physical therapist, occupational therapist and physician. Review of the OT visit note dated 12/24/2021 at 1:35 PM showed the following: - Subjective: Patient reports pain remains in chest where he/she has been diagnosed with CHF with fluid accumulation around heart contributing to pain in the chest; - Pain affects function; - Chest pain rated a nine, increased by movement and relieved by rest; and - The patient continues to report pain in chest with no relief where doctor has identified a diagnosis of CHF with fluid around heart. The documentation failed to include coordination with the clinical manager, physical therapist and physician. During an interview on 12/28/2021 at 1:30 PM, the director of patient care stated if the patient is having clinical issues the staff should contact him/her and/or the physician. The staff can notify the office and talk to the registered nurse. He/she manages therapy. PT and OT have no training to listen to lung sounds. During an interview on 12/28/2021 at 1:30 PM, the administrator stated the staff should have reported the patient’s chest pain to the registered nurse and physician. The clinician should notify the physician because they can convey the assessment of the patient better and then notify him/her. It is difficult to get insurance to approve nursing visits.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on home visit observation, and interview, the agency failed to provide in writing the name and contact information of the clinical manager in, but not limited to, three (Records/Patients #1, #2 and #3) 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, "Patient’s Bill of Rights and Responsibilities," dated October 2017, showed the patient to be informed of the name of the clinical manager. RECORD/PATIENT #1: Review of the patient's home folder, conducted on 12/28/2021 starting at 12:00 PM, during the patient's home visit, showed the agency failed to provide in writing the name of the current clinical manager. Per interview conducted during the observation, the occupational therapist (OT) A stated that he/she “thinks” the administrator was the clinical manager. RECORD/PATIENT #2 Review of the patient's home folder, conducted on 12/29/2021 starting at 9:30 AM, during the patient's home visit, showed the agency failed to provide in writing the name of the current clinical manager. Per interview conducted during the observation, the registered nurse (RN) A A stated that the administrator was the clinical manager. RECORD/PATIENT #3 Review of the patient's home folder, conducted on 12/29/2021 starting at 12:30 PM, during the patient's home visit, showed the agency failed to provide in writing the name of the current clinical manager. Per interview conducted during the observation, the physical therapy assistant (PTA) C stated that the clinical manager was the physical therapist (PT) over the patient’s case and in this patient’s case, it was PT D. During an interview on 12/27/2021 at 1:30 PM, the office manager stated that the alternate administrator was the clinical manager. During an interview on 12/28/2021 at 1:30 PM, the administrator and the director of patient care both stated: - The administrator said he/she was the clinical manager for nursing; and - The director of patient care said he/she was the clinical manager; - The director of patient care said if there are any clinical issues, staff can contact him/her and the physician; and - The director of patient care said he/she manages therapy.

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 review of the agency’s current COVID-19 plan, observation, and interview, the agency failed to incorporate Centers for Disease Prevention and Control (CDC) Guidance for COVID-19 by ensuring policies and procedures were in place for screening persons entering the agency. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency’s COVID-19 infection control program failed to show a policy addressing the screening of visitors entering the agency. Observation on entering the office space showed the following: - A sign on the front door instructing visitors not to enter the agency; and - The agency is located in a multi-office suite with no controls at the entrance to screen staff and visitors. The survey team entered the agency on 12/27/2021 with appropriate face masks in place. The surveyors introduced themselves to office staff and were escorted to a room located in the agency’s office area. Later that same day, the office staff escorted surveyors to another room down the hall from the agency office space where the surveyors worked for the remainder of the survey. Agency staff failed to screen the surveyors for elevated temperature or ask any COVID-19 screening questions upon entrance or at any time during the remainder of the survey. During an interview on 12/30/2021 at 11:00 AM, the agency’s alternate administrator, director of patient care, and office manager all stated that they did not have a policy and procedure for screening people who enter the building because they do not allow visitors to enter the building. They stated that they have a sign posted on the door. No further policies were produced.

Org. had partial/extended survey CFR(s): 484.80(f)(3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or This ELEMENT is not met as evidenced by: Based on the results of this extended level survey, resulting in noncompliance with two Conditions of Participation: 484.60-Care planning, Coordination of Services and Quality of Care and 484.105-Organization and Administration of Services, the agency may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. The restriction ends 01/11/2024.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on policy review, record review, observation, and interview, the agency failed to organize, manage, and administer its resources and staff. The agency failed to ensure: - Qualified personnel were employed (G952); - That one or more qualified individuals must provide oversight of all patient care services and personnel (G958); - Qualified oversight occurred for coordinating patient care (G962); and - Qualified oversight occurred to assure the development, implementation, and updates of the individualized plan of care (G968). The cumulative effect of these deficient practices has the potential to adversely effect the safety and coordination of care for all the agency's patients.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on review of employee files and interview, the agency failed to ensure that they employ qualified personnel by failing to verify professional nursing licenses on, but not limited to, two (Employee F and Employee G) of six employee records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of Employee F’s personnel file showed: - The date of hire was 12/07/2020; - The employee was hired for an LPN (licensed practical nurse) position; - The employee’s Missouri nursing license with an expiration date of 06/20/2021; and - The agency failed to document verification of the employee's nursing license. Review of Employee G’s personnel file showed: - The date of hire was 08/02/2021; - The employee was hired for an RN (registered nurse) position; and - The agency failed to document verification of the employee's nursing license. During an interview on 12/30/2021 with the alternate administrator, director of patient care, and office manager, the office manager stated that they verify licenses by looking them up on the quick confirm website, but they don’t always print them for the files. The office manager stated they do not keep the verified licenses in a separate binder and all confirmed license checks should be in the individual employee files. The director of patient care stated that Employee G’s license verification should be in the file and left the room to look on his/her desk. After approximately ten minutes, surveyors requested the director of patient care to return to the interview. No further evidence of license verification was provided.

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on policy review, review of the agency’s organizational structure chart, and interviews, the agency failed to ensure that qualified individuals provided oversight of all patient care services and personnel. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled “Job Description, Director of Clinical Services/Clinical Manager,” revised 10/2017, showed that the director of clinical services/clinical manager: - Supervises home health services to homebound patients in their place of residence in accordance with attending physician orders and plans of care; - Participates in developing standards which ensure safe and effective service to patients and families; - Has joint responsibility with the administrator for seeing that standards are met; - Assures ongoing assessment of patient/family needs and implementation of interdisciplinary plan of care; - Assures physician approval of plans for continuity of care; - Organizes the agency to delineate and delegate authority, functional responsibility, lines of relationship and communication to provide safe and therapeutically effective service; - Investigates and reports any problem relating to patient care or conditions which might harm the patient well-being; - Assures that patients’ plans of care are developed, implemented and updated; and - Conducts patient case conferences, in-services, staff meetings and maintains documentation. Review of the agency’s organizational structure chart, revised 03/2018, showed the agency failed to clearly identify a clinical manager. The chart showed a designated director of patient care/director of staffing was under the leadership of the administrator. Following the director of patient care/director of staffing were all of the clinical staff (registered nurses, licensed practical nurses, physical therapists, occupational therapists, speech and language pathologists, and home health aides). Showing that all clinical staff were under the direction of this person. Numerous interviews were conducted to ascertain which staff member was the clinical manager. During an interview on 12/28/2021 at 10:30 AM, the administrator stated that the director of patient care/director of staffing listed on the organizational structure chart is the clinical manager. During an interview on 12/28/2021 at 1:30 PM, the administrator stated he/she was the clinical manager. During an interview on 12/28/2021 at 1:30 PM, the director of patient care/director of staffing stated that he/she was the clinical manager. He/she stated that, if there were clinical issues, the staff can contact him/her or the physician or they can call the office and talk to the registered nurse (RN). He/she manages therapy. During an interview on 12/29/2021 at 1:39 PM, the director of patient care/director of staffing stated that his/her duties included billing, scheduling, payroll and therapy quality assurance. He/she stated that the administrator takes care of all of the clinical issues and if there was a clinical problem encountered by the nurses and therapists while in a patients home, the staff would notify the administrator. He/she stated that the administrator takes care of the clinical issues, the office manager takes care of the referrals and he/she does the scheduling. During the survey, it remained unclear which staff member preformed all the duties of the clinical manager

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on policy review, record review and interview the agency failed to provide oversight for the coordination of patient care in, but not limited to, two (Records/Patients #1 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 “Coordination of Patient Care,” revised 10/2017, showed: - Agency staff members regularly communicate to ensure that their efforts are coordinated effectively and support the objectives outlined in the plan of care; - The purpose is to ensure that quality services are being provided to patients; - The agency must assure communication with all physicians involved in the plan of care; - The agency must integrate services, whether provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines; - The director of clinical services provides oversight of all patient care services to include: * Coordinating patient care; * Ensuring that patient needs are continually assessed; * Ensuring the development, implementation and updates of the individualized plan of care; - The director of clinical services and/or nursing supervisor communicates with staff daily to discuss changes in the patient’s condition, the plan of care and the physician’s orders; and - The staff provides the physician with patient information on an ongoing basis regarding the current condition and changes in condition and outcomes of care and services. Review of the agency's policy titled “Job Description, Director of Clinical Services/Clinical Manager,” revised 10/2017, showed that the director of clinical services/clinical manager: - Supervises home health services to homebound patients in their place of residence in accordance with attending physician orders and plans of care; - Assures ongoing assessment of patient/family needs and implementation of interdisciplinary plan of care; - Investigates and reports any problem relating to patient care or conditions which might harm the patient well-being; - Assures that patients’ plans of care are developed, implemented and updated; and - Conducts patient case conferences, in-services, staff meetings and maintains documentation. Review of the agency’s policy titled “Assessment and Reassessment Guidelines,” revised 10/2017, shows: - Assessment data gathered by each discipline will be used to assess the patient’s needs and problems initially and on an ongoing basis; and - Pertinent assessment and reassessment data will be communicated to team members, patient and the patient’s physician by case conference, telephone, in person, or in writing. RECORD/PATIENT #1: Review of the plan of care (POC) dated 12/13/2021 through 02/10/2022, showed: - The patient admitted to home health services on 12/13/2021; and - Physical therapy (PT) two times a week for four weeks and occupational therapy (OT) to evaluate. Review of the OT evaluation on 12/14/2021 at 3:49 PM showed the following: - The patient had chest pain at a level 9 (a pain scale used to rate pain, zero which is no pain to 10 which is the worst pain possible), increased by movement and relieved by Tylenol (a mild pain and fever reliever); - The patient reported that he/she continued to have pain in chest with movement; and - The OT visit frequency was two times per week. The documentation failed to include coordination with the clinical manager, registered nurse, physical therapist, or physician. All OT visits after the evaluation each reported the chest pain at a "9" and failed to document communication or coordination with the clinical manager, registered nurse, physical therapist, or physician. The visit dates are as follows: 12/18/2021, 12/21/2021, 12/24/2021, and 12/28/2021. Observation on 12/28/2021 at 12:00 PM, during the patient's home visit, showed the patient's ankles and feet were swollen. Per interview conducted during observation, occupational therapist (OT) A stated that: - The patient rated his/her chest pain a 9; - The patient refused to take a diuretic because it made him/her urinate more often; - The patient refused to elevate his/her feet; - The patient said if his/her CHF exacerbated he/she would go to the emergency room; - The patient told them the pain in his/her chest was due to CHF; and - The physician had not been notified of the patient’s chest pain. During an interview on 12/28/2021 at 1:30 PM, the administrator stated that the staff should have reported the patient’s chest pain to the registered nurse and physician. The clinician should notify the physician, because they can convey the assessment of the patient better, and then notify him/her. It was difficult to get insurance to approve nursing visits. RECORD/PATIENT #3: Review of the clinical record showed a history and physical from a recent hospital stay with the date of admission 11/23/2021, and the discharge date of 11/29/2021. The patient was admitted for upper extremity (arm) weakness, left elbow bursitis (Inflammation of the elbow bursa. A bursa is a closed, fluid-filled sac that works as a cushion and gliding surface to reduce friction between tissues of the body), and infection of the left elbow bursa with sepsis (a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues). The patient went home with a paid caregiver and family member's assistance. Review of the occupational therapist (OT) and physical therapist (PT) notes from 12/14/2021 through 12/21/2021, showed the patient's pain was rated at "4" or "5" on a zero to ten scale. Review showed the physical therapist assistant's (PTA) (C) visits dated 12/23/2021 and 12/24/2021, the patient's pain was rated at "7". Interventions on both visits showed medications, rest, and OT to address. The pain was in the left elbow and shoulder. The assessment failed to show what medications the patient was taking for the pain or how often. The visit notes failed to show the supervising PT or OT was contacted regarding the increase in pain. There failed to be documentation to show the physician or the clinical manager was contacted. During an interview on 12/29/2021 at 12:30 PM, PTA C stated that PT D was over this patient and who he/she should report to.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on current survey findings with a condition level deficiency in care planning, coordination of services, and quality of care, job description review, and interviews, the agency administration failed to ensure the responsibility for the overall supervision and execution of duties of the clinical manager position including ensuring the development, implementation, and updates of the individualized plan of care in, but not limited to, two (Records/Patients #1 and #4) 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 “Job Description, Director of Clinical Services/Clinical Manager,” revised 10/2017, showed that the director of clinical services/clinical manager: - Assures ongoing assessment of patient/family needs and implementation of interdisciplinary plan of care; - Investigates and reports any problem relating to patient care or conditions which might harm the patient well-being; and - Assures that patients’ plans of care are developed, implemented and updated. RECORD/PATIENT #1 Review of the plan of care (POC) dated 12/13/2021 through 02/10/2022 showed: - Diagnoses included: Hemiplegia (muscle weakness or partial paralysis on one side of the body) following cerebral infarction (stroke), type 2 diabetes mellitus (chronic condition that affects the way the body processes blood sugar) with diabetic nephropathy (a type of nerve damage that can occur with diabetes), and acute or congestive heart failure (CHF) (chronic condition in which the heart doesn’t pump blood as well as it should); - Safety: Diabetic: Do not cut nails and bleeding precautions; - Physical therapy to minimize/eliminate risk for hospitalization due to high-risk principal diagnosis, CHF and diabetes mellitus; - Durable medical equipment included but not limited to a walker and grab bars; - The POC did not include medical equipment/supplies for blood glucose (sugar) monitoring; - The POC did not include when to check the blood glucose and how often, parameters for blood glucose levels, and when to notify the physician of abnormal results; - The patient takes anticoagulants (medicine that helps prevent blood clots); - The POC did not include specific interventions for monitoring and education of bleeding precautions; - The POC did not include specific interventions for monitoring and education of CHF; and - The POC failed to include pain parameters. RECORD/PATIENT #4: Review of the clinical record showed that the patient was admitted to the agency for wound care on 04/14/2021. The patient lives in his/her own home with his/her adult children. Review of the referring physicians orders, dated 04/13/2021, showed the patient had the following diagnoses: - Sacro-coccygeal (area near the tailbone) wound; - Hypertensive cardiovascular disease, (HCVD) (heart conditions caused by high blood pressure); - Coronary artery disease (CAD) (a narrowing or blockage of the major arteries of the heart); and - Hypothyroidism (underactive thyroid). Review of the nursing assessments dated 10/19/2021 through 12/21/2021, identified the patient had dyspnea (shortness of breath), diminished breath sounds (reduced air flow to part of the lungs), activity intolerance, and fatigue/weakness. Review of the medication profile dated, 12/10/2021, showed: - The patient takes sotalol (a medication used to treat conditions that cause irregular heartbeat) 80 milligrams (mg) by mouth twice a day, and levothyroxine (a medication used to treat an underactive thyroid gland) 75 micrograms (mcg) by mouth daily; and - The sotalol dosage was increased from one half tablet twice daily to one tablet twice daily on 06/29/2021. Review of the plans of care dated, 06/13/2021, 08/12/2021, 10/11/2021, and 12/10/2021 showed the agency failed to include the diagnoses of HCVD, CAD, and hypothyroidism and failed to include patient specific interventions related to the diagnoses of HCVD, CAD and hypothyroidism. Review of Patients #1 and #4 showed the plans of care failed to include interventions that included all diagnoses processes and interventions that needed to be included for an individualized plan of care. The agency failed to provide oversight assuring development, implementation, and updates of the individualized plan of care. During an interview on 12/29/2021 at 1:39 PM, the director of patient care/director of staffing stated that his/her duties included billing, scheduling, payroll and therapy quality assurance. He/she stated that the administrator takes care of all of the clinical issues and if there was a clinical problem encountered by the nurses and therapists while in a patients home, the staff would notify the administrator. He/she stated that the administrator takes care of the clinical issues, the office manager takes care of the referrals and he/she does the scheduling. The director of patient care/director of staffing failed fulfill the duties of plan of care oversight. After survey inquiry and investigation, it was unclear who at the agency was to fulfill the duties for care plan oversight.

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 Missouri state rules and statutes, review of employee files, and interview, the agency failed to ensure the Employee Disqualification List (EDL) was checked prior to hire in, but not limited to, one (Employee E) of six employee files reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of Section 192.2490.12 RSMo: "No person, corporation, organization, or association who received the employee disqualification list under subdivisions (1) to (7) of subsection 11 of this section shall knowingly employ any person who is on the employee disqualification list." Review of Employee E’s personnel file showed: - The date of hire was 10/10/2017; - The employee was hired for an office assistant position; and - The EDL was checked on 03/14/2018, approximately five months after the date of hire. During an interview with the alternate administrator, the director of patient care, and office manager on 12/30/2021 at 11:00 AM, the alternate administrator stated that the EDL should have been checked prior to the employees hire date.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interviews, the agency failed to ensure a completed discharge summary was sent to the primary care practitioner or other health care professional within 5 business days or the patient's discharge, in one (Record/Patient #5) out of two discharge records reviewed. This deficient practice has the potential to adversely affect post home health medical care of all the agency's patients. Findings included: Review of the agency's undated policy titled, "Discharge Summary," showed a discharge Summary will be sent within 5 business days of patient discharge to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient. Review of the discharge summary dated 11/19/2021 and signed by the nurse practitioner, failed to show the date it was sent to the provider or the date the nurse practitioner signed the summary. Review of the clinical record failed to show evidence of when the discharge summary was sent to the provider's office. During an interview on 12/29/2021 at 1:30 PM, the administrative assistant stated that he/she: - Does not stamp the discharge summary with a date; - Does not print off a fax confirmation when faxing the discharge summary; and - Will start stamping or writing in the date faxed from now on.