Every finding on record at Healthwise Home Care Solutions Inc

The following reflects the findings of the California Department of Public Health, Licensing and Certification during a Standard Abbreviated Survey for the investigation of a Complaint. The complaint number: CA00658755 was Substantiated during a Complaint Validation Survey (Federal authorization number: CA00674985) Representing the Department: 25883 - HFEN 40799 - HFEN

Strengths, goals, and care preferences CFR(s): 484.55(c)(2) The patient's strengths, goals, and care preferences, including information that may be used to demonstrate the patient's progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the Home Health Agency (HHA) failed to ensure three of three Comprehensive Assessments for two of ten sampled patients (Patients 1 and 5) contained all the necessary goals and interventions related to Patient 1 and 5's heath status. This failure resulted in the assessments not being focused on Patient 1 and 5's centered care and measurable goal outcomes. In addition, the missing information on the assessments prevented the HHA from being able to measure the progress toward achievement of the individual goals and the desired outcomes for Patient 1. Findings: Patient 1: 1. During a review of Patient 1's Start of Care Comprehensive Assessment, dated 6/19/19, the Assessment indicated Patient 1 was diagnosed with Diabetes Mellitus (chronic condition that affects the way the body processes blood sugar) and was prescribed a "1500 calorie ADA (diabetic) diet with low fiber and no concentrated sweets." Further review of the assessment indicated the specific goals and nursing interventions related to nutritional management were not completed and were left blank. During an interview on 1/30/20, at 12:35 p.m., with the Clinical Supervisor (CS1), the CS1 confirmed the Start of Care Comprehensive Assessment for Patient 1 was incomplete. The CS1 also confirmed goals and nursing interventions related to nutritional management should have been identified and completed. 2. During a review of Patient 1's Comprehensive Assessment, dated 8/15/19, the Assessment indicated Patient 1 was diagnosed with Diabetes Mellitus (chronic condition that affects the way the body processes blood sugar), and was prescribed a "1500 calorie ADA diet with low fiber and no concentrated sweets." Further review of the assessment indicated the specific goals and nursing interventions related to nutritional management were not completed and did not include goals and nursing interventions related to nutritional management. During an interview on 1/30/20, at 2:16 p.m., with the Medical Director (MD), the MD confirmed the Comprehensive Assessment for Patient 1 was incomplete and did not include goals and nursing interventions related to nutritional management. Patient 5: During a review of Patient 5's Home Health Certification and Plan of Care (POC) dated 11/14/20, the POC indicated Patient 5 had diagnoses including gastrostomy (a surgical opening into the stomach used for feeding), and Type 2 Diabetes Mellitus Patient 5 was prescribed "Regular. Low Carbohydrate. Enteral Nutrition Jevity (formula) Amount cc/day via ..." Medication orders included Novolog Insulin (a medication that helps lower mealtime blood sugar spikes), Glimepiride (a medication to control high blood sugar). Further review of the assessment indicated specific goals and nursing interventions related to glucometer use, proper care/use of enteral nutrition equipment were completed with the outcome dates left blank. During an interview on 1/14/20, at 3:30 p.m., with the Clinical Supervisor (CS2), the CS2 confirmed the POC for Patient 5 was incomplete. The CS2 acknowledged goals and nursing interventions related to glucometer use and proper care/use of enteral nutrition equipment did not have an outcome date.

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 record review, observation, and interview, the Home Health Agency (HHA) failed to review medications and update medication profiles (current list of all medications) for seven of ten sampled patients (Patients 2, 3, 4, 5, 8, 9 and 10) in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, incomplete drug orders, expired drugs, new drugs, and noncompliance with drug therapy. Failure to complete medication regimen reviews and update medication profiles had the potential for the HHA being unaware of the medication changes, placing Patients 2, 3, 4, 8, 9 and 10 at risk for serious adverse consequences, which may result in an increase in hospitalizations due to potential medication errors. Findings: Patient 2: During a home visit observation, record review, and a concurrent interview with Patient 2, on 12/11/19, at 12:42 p.m., Patient 2 stated he was taking the following medications: -Ibuprofen (anti-inflammatory) 200 mg (milligrams) 1 tablet daily for 7 days as needed, starting 10/28/19. Patient stated he still takes this medication as needed and took one dose last week -Clonazepam (used for convulsions, panic disorder, and anxiety) 1 mg 1 tablet daily as needed for what -Bupropion Hydrochloride (used for depression and to stop smoking) -Zoloft (anti-depressant) -Gabapentin (used for nerve pain and convulsions) 250 mg/5 ml (milliliters) take 1 teaspoon daily -Sudafed - taken as needed for stuffy nose, last dose taken last week -Ondansetron 4 mg 1 tablet every 8 hours as needed for nausea, obtained on 12/6/19 Patient 2 stated he has been taking the following supplements for a long time: -Probiotics -Optimized Ashwagandha (extract that is used to support memory, cognition, stress response and overall well-being) 1 tablet daily -Inforce immune strengthening supplement During a review of Patient 2's current medication profile, dated 10/30/19 - 12/28/19, the medication profile indicated Patient 2 was taking the following medications: -Probiotics (live microorganisms) - Start date 11/2/19 -Vitamin C (water-soluble vitamin important for healthy skin, teeth, bones, and blood vessels) - Start date 11/2/19 -Tramadol (narcotic-like pain reliever) 50 mg 1 tablet every 6 hours for pain for 5 days - Start date 10/31/19 -Gabapentin 250 mg/5 ml, take 1 dose 4 times a day -Zoloft -Bupropion Hydrochloride -Clonazepam 1 mg take 1 tablet twice daily During a review of Patient 2's medication reconciliation of the medication profile, dated 11/2/19 on file and the medications Patient 2 was actually taking indicated multiple inconsistencies: Patient 2 was no longer taking Vitamin C and Tramadol; was taking Gabapentin once a day, instead of the prescribed four times a day; and was taking Clonazepam once a day as needed instead of twice a day as indicated on the medication profile. In addition, Patient 2 had two new medications, Ibuprofen and Ondanestron, which were not listed on the medication profile, and were in Patient 2's possession prior to the previous HHA visit made on 12/7/19. Patient 2 was also taking supplements that were not listed on the medication profile (Optimized Ashwagandha and Inforce immune strengthening supplement). During an interview on 12/11/19, at 4:49 p.m.,with the Medical Director (MD) and the Director of Patient Care Services (DPCS), the MD and DPCS confirmed nurses are expected to review patients' medications every visit and are expected to update medication profiles in case any changes are identified. The MD and DPCS also confirmed Patient 2 was visited by a nurse on 12/7/19 and Patient 2's medication profile should have been updated then and confirmed the inconsistencies. Patient 3: During a home visit observation and a concurrent interview on 12/11/19, at 7:25 p.m.,with Patient 3's Family Member (FM), the FM sated Patient 3 is currently taking only two medications: Ondansetron and Prochlorperazine. The FM also indicated Patient 3 has not been taking any other medications or vitamins since being discharged from a general acute care hospital, which was prior to being admitted to the HHA. During a review of Patient 3's current medication profile, dated 10/26/19, the medication profile indicated Patient 3 was taking the following medications: -Prochlorperazine (used for nausea and vomiting) -Ondansetron (used for nausea and vomiting) -Perodex mouthwash (used to reduce bacteria in the mouth) -Amiodarone Hydrochloride (used to treat heart rhythm problems) -Nebivolol Hydrochloride (used to treat high blood pressure) -Gabapentin (used for nerve pain and convulsions) -Famotidine (used to decrease the amount of stomach acid production) -Anoro Ellipta Inhalation (used to improve breathing problems) -Acetaminophen (used for pain or fever) -Multivitamins (supplement) -Ascorbic Acid (Vitamin C - water-soluble vitamin important for healthy skin, teeth, bones, and blood vessels) -Biotin (water-soluble vitamin - used to improve health of the hair, skin, and nails) -Atorvastatin (used to treat high cholesterol) -Meclizine Hydrochloride (used to prevent and control nausea, vomiting, and dizziness). Review of the Skilled Nursing Visit (SNV) Note dated 12/4/19, the SNV Note indicated Patient 3 was last visited by a HHA nurse on 12/4/19. During an interview on 1/30/20, at 3:56 p.m., with the MD, the MD confirmed nurses are expected to review all medications patients are taking every visit and expected to update medication profiles accordingly. The MD also confirmed the inconsistencies. Patient 4: During a review of Patient 4's Medication Record dated 11/21/20, the Medication Record revealed Patient 4 was taking the following medications: -Tylenol Extra Strength (non-narcotic pain reliever) -Ibuprofen (anti-inflammatory) -oxyCODONE-Acetaminophen (narcotic pain reliever) -Omeprazole (ulcer drug) and -Amoxicillin (antibiotic) Review of Patient 4's Skilled Nursing Visit (SNV) Note dated 11/28/20, the SNV Note indicated Patient 4 was taking Tramadol (narcotic pain reliever) for pain. Review of SNV Note dated 12/2/20, revealed under "Comments", "Teaching performed re: use of stool softener..." and under Skilled Intervention Assessment, "Pt (patient) reported intermittent periods of nausea...Discussed...utilizing prn (as needed) Zofran (medication for nausea)." Tramadol, stool softener and Zofran were not on the initial Medication Record nor was there an updated Medication Record or a physician order. Patient 5: During a review of Patient 5's Home Health Certification and Plan of Care (POC), dated 11/14/20, the POC indicated medication orders including but not limited to, "Losartan Potassium [used to treat high blood pressure] Oral 25 mg 1 Tab(s) daily, Glimepiride Oral 2 mg 1 Tab(s) daily, Allopurinol (used to treat gout and certain types of kidney stones) Oral 300 mg 1 Tab(s) daily, Ferrous Sulfate ( [Fe-Iron] used to treat low red blood cell counts) Oral 325 (Fe 65) mg 1 Tab(s) two times daily, and Furosemide (used to reduce extra fluid in the body) Oral 40 mg 1 Tab(s) two times daily. During a review of Patient 5's Medication Profile, dated 11/14/20, the Medication Profile indicated the Furosemide dosage as "Furosemide 40 mg 2 in AM 1 in PM." Further review of the Medication Profile revealed there was no documentation of Losartan Potassium, Glimepiride, Allopurinol or Ferrous Sulfate. During a review of Patient 5's SNV Note dated 11/21/20, the SNV Note indicated under Vital Signs Comments, "Per family, MD d/c (discontinued) diabetic meds..." There was no updated Medication Profile or a physician order documenting the change in the diabetic medications. During a concurrent record review and interview on 1/14/21 at 3:30 p.m. with the Clinical Supervisor (CS2), the CS2 confirmed the medication profile for Patient 5, dated 11/14/20, was not accurate. The CS2 further acknowledged the Medication Profile was not updated and available to field staff. Patient 8: During a review of Patient 8's SNV Note dated 12/11/20, the SNV Note indicated Patient 8 was taking Tylenol for pain and a SNV Note dated 12/18/21 indicated the patient was taking Gabapentin for pain. Neither Tylenol or Gabapentin were on Patient 8's medication profile. Patient 9: During a record review of Patient 9's Patient Medication Record, dated 8/16/20, the Patient Medication Record indicated, "Levaquin (antibiotic) Oral 750 mg 1 tab(s) Q (every) 24 HR (hours) X 6 days," with a start date of 8/14/20. During a record review of Patient 9's Skilled Nursing Visit (SNV) Notes in the "Current Pain Management & Effectiveness" section, dated 9/18/20, the SNV Note indicated, "Lyrica effective." Further review of the Medical Record indicated, there was no evidence of a physician's order in the medical record for the use of Lyrica. During a concurrent record review and interview on 1/14/21, at 2:05 p.m., of Patient 9's Medical Record, with the Clinical Supervisor (CS2), the CS2 acknowledged there was no update to the Patient Medication Record after six days when Levaquin was completed and indicated that an update should have been completed. CS2 further confirmed there was no physician order for Lyrica use and there should be. Patient 10: During a review of Patient 10's SNV Note dated 11/21/20, the SNV Note indicated under Medication change, "Family Member (FM) reported pt (Patient) reaction to Baclofen (muscle relaxant)... Pt no longer taking and notified MD. Added: Calcium 2 caps/day, Compazine (anti-nausea medication)..." Review of a SNV Note dated 11/28/20 indicated under Medication change, "MD (Medical Doctor) reinstated Rx (prescription) for Soma...prn muscle spasms...". The same SNV Note indicated under Skilled Intervention Assessment, "Zofran (anti-nausea medication) somewhat effective, recently increased from 4 mg to 8 mg per dose. Pt. does not like Compazine". Calcium, Compazine and Zofran were not on the initial Medication Record nor was there an updated Medication Record or a physician order for the Calcium, Compazine and Zofran. During an interview on 1/21/21 at 2:20 p.m. with the Clinical Supervisor (CS2), the CS2 stated the medication profiles for Patients 4, 8, and 10 were not updated and available to field staff and confirmed the inaccuracies. During a review of the agency's policy and procedure titled, "Medication Profile", revised 11/18, indicated, "Patients receiving medications will have a current, accurate medication profile in the clinical record."

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the Home Health Agency (HHA) failed to complete the Discharge OASIS (Outcome and Assessment Information Set - a comprehensive discharge assessment) for one of ten patients (Patient 1) within the required 48 hours. The failure to complete the Discharge OASIS evaluation within 48 hours had the potential to cause a delay in determining the discharge needs of the patient. Findings: According to the Centers for Medicare and Medicaid Services (a federal agency that administers the Medicare and Medicaid programs) guidance "Outcome and Assessment Information Set OASIS-D Guidance Manual," effective 1/1/19, indicated in part, "For the transfer to inpatient facility, discharge from home care, death at home, and other follow-up, the assessments must be completed on, or within 48 hours of becoming aware of the significant change in condition, transfer, discharge, or death date." During a review of Patient 1's physician order, dated 10/12/19, the physician's order indicated, "Patient discharged from (name of HHA) services due to inability for SN (skilled nurse) to service patient's location." Further review of the clinical record indicated the Discharge OASIS was not part of the clinical record. During an interview on 11/25/19, at 2:04 p.m., with the Director of Patient Care Services (DPCS), the DPCS stated "Discharge OASIS has not been completed yet."

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 may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the Home Health Agency (HHA) failed to ensure the Plan of Care (POC) for five of ten sampled patients (Patients 1, 5, 6, 7, and 8) included all the necessary components. Patient 1: The HHA failed to include the specific instructions related to managing Patient 1's diagnosis of Diabetes Mellitus (chronic condition that affects the way the body processes blood sugar). The POC did not contain the specific interventions related to disease management, such as the symptoms to assess, acceptable blood sugar parameters, when to notify the physician, and patient/caregiver education. Patient 5: The HHA failed to ensure: 1. Patient 5's diet orders were complete and 2. There were physician orders for Oxygen therapy for Patient 5. Patient 6: The HHA failed to ensure specific education or instructions related to radiation therapy treatments (a cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors) were included on Patient 6's POC. Patient 6 had a diagnosis of malignant neoplasm (a cancerous tumor(s) that spread to other parts of the body) of pancreas (an organ in the abdomen that helps in digestion and regulates blood sugar) and was receiving radiation treatments that required skilled education and instructions. Patient 7: 1. The HHA failed to ensure Patient 7's diagnoses were correct. Patient 7 had a diagnosis of an abscess (painful collection of pus, usually caused by a bacterial infection) on his penis. Patient 7 had undergone a penectomy (surgical procedure to remove all or part of the penis) for cancer. Patient 7 could not have an abscess on his penis due to his penis having been surgically removed. 2. The HHA failed to ensure Patient 7's medications were correct on the Plan of Care (POC). Under medications , Mupirocin Calcium External 2% (topical antibacterial cream), apply to L (left) knee with each dressing change. There was no order for dressing changes to the left knee. In addition, Coobetasol Protionate cream (a cream used to treat a variety of skin conditions) to a rash. There was no documentation as to the area or type of rash nor was there an order to apply the cream to a rash. Patient 8: The HHA failed to identify the origin and type of Patient 8's wound. Patient 8 was admitted with change or removal of a surgical dressing as the primary diagnosis, but there was no surgical procedure listed. Additional diagnoses were diabetes mellitus with foot ulcer (an open sore or wound that occurs with patients with diabetes) and non-pressure ulcer other part of right foot. These failures had the potential to result in Patients 1, 3, 5, 6, 7 and 8's specific health needs not being met. Findings: Patient 1: During a review of Patient 1's POC dated 8/18/19 to 10/16/19, the POC indicated Patient 1 was diagnosed with Type 2 diabetes mellitus (with this type of diabetes, the body does not produce enough insulin). Further review of the POC indicated, the POC did not contain the specific interventions related to disease management, such as the symptoms to assess, acceptable blood sugar parameters (how much sugar is present in the blood), when to notify the physician of symptoms and blood sugar levels outside of parameters, etc., and patient/caregiver education. During an interview on 1/30/20, at 2:18 p.m., with the Medical Director (MD), the MD confirmed the POC did not contain the specific instructions related to the management of Patient 1's Diabetes Mellitus. Patient 5: During a review of the "Home Health Certification and Plan of Care" (POC) for Patient 5, dated 11/14/20, the POC indicated, Patient 5 was admitted with diagnoses including but not limited to encounter for attention to gastrostomy (an opening into the stomach for nutritional support), congestive heart failure (condition where heart muscle doesn't pump blood as well as it should), chronic obstructive pulmonary disease (chronic inflammatory lung disease that causes obstructed airflow from the lungs), and dysphagia (condition where ability to eat and drink is disrupted). Further review of Patient 5's POC, dated 11/14/20, the "Nutritional Requirements" (diet orders) on the POC indicated, "Regular. Low Carbohydrate. Enteral Nutrition Jevity (formula)..." The diet orders did not indicate the amount of formula to be given or how often. During an interview on 1/14/21, at 3:30 p.m., with the clinical supervisor (CS2), the CS2 confirmed the diet orders were incomplete and required clarification. During a review of the Respiratory section of the Skilled Nursing Visit (SNV) Notes for Patient 5, dated 12/1/20, the SNV Notes indicated, Patient 5's "O2 (oxygen) was set to 5L (liters), but nasal cannula (a flexible tube that is placed under the nose to deliver oxygen) was not in place. Pt (Patient) agitated, resisted adjustment, eventually complied with replacement of nasal cannula." During a review of the Physician's orders on the POC, dated 11/14/20, there were no orders, nursing interventions or goals for oxygen use. During an interview on 1/14/20, at 3:30 p.m., with the clinical supervisor (CS2), the CS2 agreed there were no Physician orders, nursing interventions or goals for oxygen use. Patient 6: During a review of the "Home Health Certification and Plan of Care" (POC) for Patient 6, dated 11/10/20, the POC indicated Patient 6 was admitted to the HHA with diagnoses including but not limited to malignant neoplasm (cancer) of pancreas (an organ in the abdomen that helps in digestion and regulates blood sugar). Further review of the POC indicated it did not contain any specific instructions or patient specific education related to radiation therapy. During a review of the Skilled Nursing Visit (SNV) Notes for Patient 6, dated 11/17/20, 11/24/20, 12/11/20, and 12/17/20, the SNV Notes indicated "the patient had a rad (radiation) mold made on Tues. (Tuesday) with radiation to start in one to two weeks". During a review of the "Physician Order" for Patient 6, dated 12/3/20, the Physician Order updated the skilled nursing visits, effective 12/6/20, to one visit per week and one as needed visit (PRN) for symptom management of radiation treatment. During review of the SNV Notes for Patient 6, dated 12/3/20 and 12/17/20, the SNV Notes indicated "Discussed plan to assess effects of radiation therapy. Further review of the SNV Notes, dated 12/17/20, the SNV Notes indicated, "family and patient pleased that patient is tolerating radiation well with just increased fatigue." There was no evidence of education or instructions in the SNV Notes related to radiation therapy treatments given to Patient 6. During an interview on 1/14/21, at 2:50 p.m., with the clinical supervisor (CS2), the CS2 confirmed there was no documentation related to radiation therapy on the plan of care or evidence of education in the SNV Notes. The CS2 further acknowledged there should have been documentation of planned radiation on the plan of care and in the SNV Notes. Patient 7: During a review of Patient 7's Health Certification and Plan of Care (POC) dated 10/19/2020 to 12/17/2020 (admission date was 10/30/2018), the POC indicated, Pt 7 was admitted with Encounter for fitting and adjustment of urinary device (inserting a tube into the bladder for urine output); Abscess (painful collection of pus, usually caused by a bacterial infection) of corpus cavernosum and penis and Gastrostomy status (tube inserted into the stomach for food, fluids and medications). There were no care orders for the penis abscess or the gastrostomy status. The same POC revealed Patient 7 had the following medications: Mupirocin Calcium External cream (topical antibacterial cream)...apply to L (left) knee with each dressing change and Coobetasol Protionate cream (a cream used to treat a variety of skin conditions) apply to rash daily. There were no orders for dressing changes to the L knee or to apply cream to a rash. A review of Patient 7's SNV Note dated 11/13/20 indicated Patient 7 had a penectomy (surgical procedure to remove all or part of the penis for cancer). In addition, the SNV Note also indicated Patient 7 had no skin issues and no gastrostomy tube. Patient 7 could not have an abscess on his penis due to his penis having been surgically removed. Also, Patient 7 did not require left knee dressing changes as there was no evidence of an infection to the left knee. Patient 7 had no skin issues documented, therefore, no cream was required for a rash. During an interview on 1/21/21 at 2:20 p.m. with the Clinical Supervisor (CS2), the CS2 confirmed the diagnoses for Patient 7 had not been updated and were incorrect. The CS2 also confirmed Patient 7 did not have a dressing to the left knee or a rash or a gastrostomy tube. Patient 8: During a review of Patient 8's POC dated 10/31/2020 to 12/29/2020, the POC indicated Patient 8 was admitted for Encounter for change or removal of surgical wound dressing, Type 2 diabetes mellitus with foot ulcer and non-pressure ulcer other part of right foot. There were no surgical procedures listed. During an interview on 1/21/21 at 2:20 p.m. with the Clinical Supervisor (CS2), the CS2 confirmed the diagnoses for Patient 8 had not been updated and were incorrect. During a review of the agency's policy and procedure titled "Care Planning Process", revised 4/18, indicated "...The care planning process will be documented on the plan of care, individualized discipline-specific care plans (if applicable), clinical notes, medication profiles, care conference/summary forms, and discharge/clinical summaries. Definitions: 1. Individualized Plan of Care: The patient-specific clinical plan of care includes all pertinent diagnoses...instructions... Based on the assessment and conclusions, the plan of care will include, but not be limited to: Patient specific interventions and education ...All pertinent care orders from all physicians involved in the plan of care, including verbal orders ...Specific services and treatments to be provided ...All pertinent diagnoses ..."

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician orders. This STANDARD is not met as evidenced by: Based on record review and interview, the Home Health Agency (HHA) failed to provide care in conformance with physician's orders for one of three sampled patients (Patient 1). The HHA failed to flush (syringe to push a small amount of saline or heparin into the port and catheter) Patient 1's Port-a-Cath (a device that is usually placed under the skin in the right side of the chest and attached to a catheter [a thin, flexible tube] that is threaded into a large vein above the right side of the heart used to give fluids, blood transfusions, chemotherapy, and other drugs and also for taking blood samples) with the prescribed amount of Normal Saline (NS-sterile solution of salt and water) and Heparin (blood thinning medication) to keep the catheter patent. This failure resulted in the HHA staff flushing Patient 1's Port-a-Cath with a different than prescribed amount of NS and Heparin, placing Patient 1 at risk for having Port-a-Cath complications. Findings: According to "Fundamentals of Nursing - 7th Edition", (Potter and Perry; 2009) "Nurses follow physicians' orders unless they believe the orders are in error or harm clients. Therefore you need to assess all orders, and if you find one to be erroneous or harmful, further clarification from the physician is necessary." During a review of Patient 1's Plan of Care (POC) dated 6/19/19 to 8/18/19, the POC indicated, a physician order for "SN (skilled nurse) to access port (Port-a-Cath) every 14 days to administer 5FU (chemotherapy drug to treat cancer), flush with 10 cc (cubic centimeters) NS before and after medication and follow with 10 cc (100 units/cc) Heparin." Review of Patient 1's Skilled Nursing Visit (SNV) Note dated 6/20/19, the SNV Note indicated, the nurse performed the flushing procedure before administering the 5FU and "flushed with 20 ml (milliliters - one milliliter is equivalent to one cc) NS", instead of the prescribed 10 cc. There was no evidence in the record of a physician order for the change in the flushing amount of NS. Review of Patient 1's SVN Note dated 6/22/19, the SNV Note indicated, the nurse performed the flushing procedure after the medication was administered and "Flushed central port (Port-a-Cath) with 20 ml NS and 5 ml Heparin 500 units ..." instead of the prescribed 10 cc of NS and 10 cc of Heparin. There was no evidence in the record of a physician order for the change in the flushing amounts of NS and Heparin. Review of Patient 1's SNV Note dated 6/28/19, the SNV Note indicated, the "De-accessed (remove needle) patient's (Patient 1's) port on right anterior (front) chest, prior observed brisk blood return and flushed with 20 ml NS ...accessed patients port with 20 ml NS and 5 ml Heparin ...", instead of the prescribed 10 cc of NS before and after and 10 cc of Heparin. There was no evidence in the record of a physician order for the change in the flushing amounts of NS and Heparin. Review of Patient 1's SNV Note dated 7/5/19,the SNV Note indicated, the nurse performed the flushing procedure before administering the medication and "Flushed portacath (Port-a-Cath) with 20 ml NS observed blood return", instead of the prescribed 10 cc. There was no evidence in the record of a physician order for the change in the flushing amount of NS. Review of Patient 1's SNV Note dated 7/7/19, the SNV Noted indicated, the nurse performed the flushing procedure after the medication was administered and "Flushed portacath with 20 ml NS, 500 units of Heparin" instead of the prescribed 10 cc of NS and 10 cc of Heparin. There was no evidence in the record of a physician order for the change in the flushing amounts of NS and Heparin. Review of Patient 1's SNV Note dated 7/20/19, the SNV Note indicated, the nurse performed the flushing procedure after the medication was administered and "Flushed port a cath with 20 ml NS, 500 units of heparin ..." instead of the prescribed 10 cc of NS and 10 cc of Heparin. There was no evidence in the record of a physician order for the change in the flushing amounts of NS and Heparin. Review of Patient 1's SNV Note dated 8/1/19, the SNV Note indicated, the nurse performed the flushing procedure before administering the medication and "Flushed portacath with 20 ml NS observed blood return", instead of the prescribed 10 cc. There was no evidence in the record of a physician order for the change in the flushing amount of NS. Review of Patient 1's SNV Note dated 8/3/19, the SNV Note indicated, the nurse performed the flushing procedure after the medication was administered and "Port flushed with ...followed by 5 ML (milliliters) Heparin", instead of the prescribed 10 cc of Heparin. There was no evidence in the record of a physician order for the change in the flushing amount of Heparin. Review of Patient 1's SNV Note dated 8/17/19, the SNV Note indicated, the nurse performed the flushing procedure after the medication was administered and "Flushed port a cath (Port-a-cath) with 20 ml NS, 500 units (5 mls) of heparin ..." instead of the prescribed 10 cc of NS and 10 cc of Heparin. There was no evidence in the record of a physician order for the change in the flushing amounts of NS and Heparin. During an interview on 1/30/20, at 1:04 p.m., with the Clinical Supervisor (CS1) and the Referral Intake Coordinator (RIC), the CS1 confirmed nurses are expected to follow physicians' orders. The CS1 also confirmed the physician's order was not followed, the ordered amounts of 10 ml of NS and 10 ml of Heparin were not administered.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician. This ELEMENT is not met as evidenced by: Based on interview and record review, the facility failed to follow physician orders for two of ten patients (Patients 4 and 5) when an extra Skilled Nursing Visit (SNV) was made for Patient 4 and an extra Physical Therapy (PT) visit was made for Patient 5. This failure had the potential for Patient 4 to receive care that did not meet their needs as the physician was unaware of the visits and the service(s) provided during the visit. Findings: Patient 4: During a review of Patient 4's Physician Order dated 12/17/20, the physician's order indicated, "SN (Skilled Nursing) Eff. (effective) 11/29/20 1w5 (one time a week for 5 weeks)". Review of Patient 4's SNV Notes revealed two SNVs were made the week of 11/29/20, instead of one visit as ordered. During an interview on 1/21/21 at 2 p.m. with the Clinical Supervisor (CS2), the CS2 confirmed two SN visits were made during the week of 11/29/20 instead of one as ordered. Patient 5: During a review of Patient 5's Physician Order dated 11/20/20, the physician order indicated, PT Eff. (effective) 11/22/20 1w1 (one time per week for one week)". Review of Patient 5's PT notes revealed two PT visits were made the week of 11/22/20, instead of one visit as ordered. During an interview on 1/14/21 at 3:30 p.m., with the clinical supervisor (CS2), the CS2 confirmed two PT visits occurred during week of 11/22/20 instead of one as ordered .

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(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 record review and interview, the Home Health Agency (HHA) failed to notify the physician when five of ten sampled patients (Patients 1, 2, 3, 8, and 9) had a change in condition. Patient 1: The HHA failed to notify the physician when: 1. Patient 1 developed blisters on skin around the ileostomy ([ostomy] artificial opening surgically made in the abdomen to allow for the removal of waste materials) site. This failure had the potential for Patient 1 to have complications related to ostomy management and care. 2. Patient 1 developed abnormal lung sounds (noises produced by the structures of the lungs during breathing; abnormal lung sounds can indicate a lung problem, such as an obstruction, inflammation, or infection). This failure resulted in Patient 1's potential problem with the lungs not being addressed, placing Patient 1 at risk for infection and health complications. 3. Patient 1 developed oral thrush (infection in which fungus [yeast-like organism] accumulates in the mouth and causes white lesions on the tongue or inner cheeks). This failure placed Patient 1 at risk for having health complications. 4. Patient 1 developed low blood pressure (a measure of the force that your heart uses to pump blood around your body). This failure resulted in Patient 1's low blood pressure episode not being addressed, placing Patient 1 at risk for complications. Patient 2: The HHA failed to notify the physician when: 1. Patient 2 developed a change in sputum (thick mucus which is coughed up from the lungs) odor and color. This failure resulted in Patient 2's change in condition not being addressed, placing Patient 2 at risk for health complications, such as infection. 2. Patient 2's wound on the left forearm increased in size. This failure resulted in Patient 2's wound deterioration not being addressed, placing Patient 2 at risk for health complications. 3. Patient 2 developed new findings: the raised area on left neck became larger, developed voice gurgling (hollow bubbling sound) with inability to bring up phlegm (thick substance in the nose and throat), developed yellow drainage from the gastrostomy site (surgical opening into the stomach), and developed a pinpoint opening in the tracheostomy site (tube inserted into a surgically created opening through the neck into the trachea [windpipe] to allow air to enter the lungs). This failure resulted in Patient 2's health deterioration not being addressed, placing Patient 2 at risk for health complications. Patient 3: The HHA failed to notify the physician when: 1. Patient 3's wound significantly increased in size. This failure resulted in Patient 3's potential wound deterioration not being addressed, placing Patient 3 at risk for health complications. 2. the HHA failed to obtain instructions from the physician to address Patient 3's low blood pressure ([BP]a measure of the force that your heart uses to pump blood around your body) episode. This failure placed Patient 3 at risk for complications related to low blood pressure. Patient 8: The HHA failed to notify the physician when Patient 4's blood pressure ([BP] a measure of the force that your heart uses to pump blood around your body) was high. This failure placed Patient 4 at risk for complications related to high blood pressure. Patient 9: The HHA failed to notify the physician when Patient 9 had worsening of a pressure ulcer (localized damage to the skin and/or underlying tissue that usually occur over a bony prominence as a result of usually long-term pressure). This agency failure had the potential for Patient 9's pressure ulcer not being addressed, placing Patient 9 at risk for complications. Findings: Patient 1: 1. During a review of Patient 1's Start of Care Comprehensive Assessment, dated 6/19/19, the Assessment indicated, Patient 1 had a colostomy with surrounding tissue being "macerated (softened by soaking in a liquid)". Review of a Skilled Nursing Visit (SVN) Note, dated 6/21/19, the SNV Note indicated, Patient 1's ileostomy surrounding skin "appeared blistered". Further review of the note indicated the nurse contacted the HHA office and the HHA office "will attempt to contact (name of Patient 1's health insurance company) for further instructions and keep surrounding skin from further breakdown." The clinical record did not contain any documentation Patient 1's physician was notified about the new finding. Review of a Skilled Nursing Visit note, dated 6/22/19, the SNV Note indicated, Patient 1's colostomy surrounding skin was still "blistered". The clinical record did not contain any documentation Patient 1's physician was notified about the ongoing problem. During an interview on 1/30/20, at 1:04 p.m., and 1:09 p.m., with the Clinical Supervisor (CS1) and the Referral Intake Coordinator (RIC), the CS1 and RIC confirmed Patient 1's physician was not notified about the colostomy surrounding skin blistering. The CS1 confirmed Patient 1's physician should have been notified. 2. During a review of Patient 1's Start of Care Comprehensive Assessment, dated 6/19/19, the Assessment indicated, Patient 1 was admitted to the HHA with clear lung sounds. Review of seven SVN Notes, dated 6/20 - 7/5/19, indicated Patient 1's lung sounds were "WNL (within normal limits)". Review of the SVN Note, dated 7/7/19, indicated Patient 1 developed "rales (abnormal lung sounds characterized by discontinuous clicking or rattling sounds)" in the left lung. The clinical record did not contain any documentation Patient 1's physician was notified about the new finding. During an interview on 1/30/20, at 1:23 p.m., with the CS1 and the RIC, the CS1 and RIC confirmed Patient 1's physician was not notified about the newly identified problem with the lungs. The CS1 confirmed Patient 1's physician should have been notified. 3. During a review of Patient 1's SVN Note, dated 8/1/19, the SNV Note indicated, "Educated patient regarding swishing with water and baking soda to help with thrush." The clinical record did not contain any documentation Patient 1's physician was notified about the new finding. During an interview on 1/30/20, at 1:27 p.m., with the CS1 and the RIC, the CS1 and RIC confirmed Patient 1's physician was not notified about the new finding of thrush. The CS1 confirmed Patient 1's physician should have been notified. 4. During a review of Patient 1's Plan of Care (POC) dated 6/19/19 to 8/17/19, the POC indicated, "Notify physician of ...Systolic (maximum pressure your heart exerts while beating) BP ([blood pressure] a measure of the force that your heart uses to pump blood around your body) greater than (>) 160 or less than () 160 or less than () 90 or less than () 160 or less than () 90 or less than (<) 60." Review of a SNV Note dated 11/9/20, the SNV Note indicated Patient 8's BP was 173/64. There was no evidence in the record the physician was notified of the high BP. During an interview on 1/21/21 at 2:30 p.m. with the Clinical Supervisor 2 (CS2), the CS2 confirmed there was no evidence in the record the physician was notified about Patient 8's blood pressure and should have been. Review of the agency's policy and procedure titled "Monitoring Patient's Response/Reporting to Physician", revised 4/18, indicated "Clinicians will monitor , document, and report the patient's response to care and treatment provided on each home visit ...Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient ...The patient's physician will be contacted on the same day when any of the following occur ...Changes in the patient's condition ...Changes in the patient's psychosocial status, family/caregiver support, home environment ...Changes that occurred regarding diagnoses, prognosis, or treatment (including procedures, medications, precautions, and limitations) ...When there is any problem implementing the plan of care ...All conferences or attempts to communicate with the physician will be documented in the clinical record ...Documentation of physician notification will include: 1. Date and time contacted 2. Patient name 3. Name of physician notified or his/her representative 4. Reason for notification 5. Physician's response 6. Action taken or orders obtained 7. Professional's signature and title ....Documentation of attempted physician notification will include: 1. Date and time 2. Patient name 3. Name of physician attempting to notify 4. Reason for notification 5. Name of person taking message ..." Patient 9: During a review of the OASIS ([Outcome and Assessment Information Set], a tool to collect comprehensive assessment data related to home health care patients) for Patient 9, dated 8/15/20, the OASIS indicated, in the skin assessment area that Patient 9 had a Stage 2 pressure ulcer (shallow open ulcer with partial thickness loss of the dermis [a layer of skin]) on the perineum with measurements 0 centimeters (cm) by 0 cm by 0 cm. During a review of a Skilled Nursing Visit (SNV) Note for Patient 9, dated 9/18/20, the SNV Note indicated, Patient 9's pressure ulcer was now a Stage 3 pressure ulcer (full thickness tissue loss) with measurements of 2 cm by 1.5 cm by 1 cm. There was no documentation in the medical record indicating the physician was notified of the stage change to the pressure ulcer. During a review of a SNV Note for Patient 9, dated 9/25/20, the SNV Note indicated Patient 9's stage 3 pressure ulcer now had tunneling (a secondary wound that occurs alongside the primary wound forming a narrow opening or channel that can extend in any direction underneath the skin and through the soft tissues) measuring 2 cm. There was no documentation in the medical record indicating that the physician was notified of this change in the pressure ulcer condition. During an interview on 1/14/21, at 2:05 p.m., with the clinical supervisor (CS2), the CS2 confirmed these changes in the pressure ulcer appearance were not communicated to the physician and should have been.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to follow the accepted standards of practice and the standard precautions (a set of infection control practices used to prevent transmission of diseases) when providing care to two of two observed patients (Patients 2 and 3) during the home visits. These failures resulted in the potential for cross-contamination and placed Patients 2 and 3 at risk for infection. Findings: According to "Fundamentals of Nursing - 7th Edition", (Potter and Perry; 2009) "The nurse follows certain principles and procedures, including standard precautions, to prevent and control infection and its spread...Standard precautions apply to contact with blood, body fluid, nonintact skin, and mucous membranes from all clients. These precautions protect the client and provide protection of the health care staff as directed by the Occupational Safety and Health Administration (OSHA) (2001)." According to the Centers for Disease Control and Prevention (CDC - serves as the national focus for developing and applying disease prevention and control, environmental health, and health promotion and health education activities designed to improve the health of the people of the United States) "Healthcare providers ...When and how to perform hand hygiene...", (https://www.cdc.gov/hand hygiene/providers/), "Multiple opportunities for hand hygiene may occur during a single care episode ... Use an Alcohol-Based Hand Sanitizer: Immediately before touching a patient; Before performing an aseptic (free from contamination caused by harmful bacteria, viruses, or other microorganisms) task ...or handling invasive medical devices; Before moving from work on a soiled body site to a clean body site on the same patient; After touching a patient or the patient's immediate environment; After contact with blood, body fluids or contaminated surfaces; Immediately after glove removal ..." Patient 2: During an observation on 12/11/19 at 12:42 p.m., at Patient 2's home a Skilled Nurse (SN 1) was observed doing the following: *SN 1 did not disinfect (clean with a chemical in order to destroy bacteria) the blood pressure equipment before and after use; *SN 1 contaminated clean gloves by allowing the gloves to come in contact with non-clean surfaces (such as the interior and the exterior of the nursing bag, which is a bag used to carry supplies and equipment between patients) and proceeded to do wound care with the same gloves on; *On two occasions during wound care, SN 1 did not perform hand hygiene immediately after glove removal and proceeded to touch items in the environment; *After touching a non-clean nursing bag, SN 1 was observed to glove without performing hand hygiene prior; *SN 1 did not disinfect scissors prior to using those to cut a clean dressing. During an interview on 12/11/19, at 1:33 p.m., with SN 1, SN 1 confirmed she did not follow the infection prevention practices when she failed to do the following: disinfect the medical equipment, perform hand hygiene before and after gloving, and ensure clean gloves were used at all times. During an interview on 12/11/19, at 4:46 p.m., with the Director of Patient Care Services (DPCS) and the Medical Director (MD), the DPCS and MD confirmed nurses are expected to follow the standards of practice and the standard precautions when providing care to patients, including disinfecting medical equipment, performing hand hygiene, and using clean gloves. Patient 3: During an observation on 12/11/19, starting at 6:45 p.m., at Patient 3's home a SN (SN 2) did not disinfect the stethoscope (medical instrument used for listening) and did not perform hand hygiene between re-gloving on one occasion during wound care. During an interview on 12/11/19, at 7:48 p.m., with SN 2, SN 2 confirmed she failed to disinfect the stethoscope and failed to perform hand hygiene between re-gloving on one occasion during wound care. During an interview on 1/30/20, at 3:56 p.m., with the MD, the MD confirmed nurses are expected to follow infection control and prevention practices and are expected to disinfect medical equipment and perform hand hygiene between re-gloving. During a review of the agency's policy and procedure titled "Hand hygiene", revised 4/18, indicated "Purpose: To prevent cross-contamination and home health-acquired infections. Policy: Personnel providing care in the home setting will regularly wash their hands, per the most recently published CDC regulations and guidelines (Categories 1A, 1B, and 1C) for hand hygiene in health care settings ...Hand decontamination using an alcohol-based hand rub (alcohol-containing preparation designed for application to the hands to inactivate microorganisms and/or temporarily suppress their growth) should be performed: Before having direct contact with patients ...After contact with a patient's intact skin (when taking a pulse, blood pressure, or lifting a patient). After contact with body fluids or excretions, mucous membranes (line many body cavities and tubular organs including the gut and respiratory passages), non-intact skin, and wound dressings, if hands are not visibly contaminated ...After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient. After removing gloves ..."

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review, interview, and observation the Home Health Agency (HHA) failed to provide the necessary services as prescribed by a physician and indicated in the individualized plan of care (POC) for eight of ten sampled patients (Patients 1, 2, 3, 5, 6, 7, 8 and 9). Patient 1 and 2: The HHA failed to: 1. continuously provide the necessary ileostomy ([ostomy]an artificial opening surgically made in the abdomen to allow for the removal of waste materials) supplies (special medical supplies used for ostomy care). 2. follow the prescribed nursing visit frequency. 3. perform complete assessments of all body systems. Patient 3: The HHA failed to perform complete assessments of all body systems. Patient 5: The HHA failed to: 1. provide visits as ordered. Patient 5 had a missed Skilled Nursing Visit. 2. provide a speech therapy (ST) evaluation for Patient 5. Patient 6: The HHA failed to: 1. monitor Patient 6's oxygen saturation (O2 sat [the amount of oxygen,in percent, bound to hemoglobin in red blood cells]) on multiple home visits. 2. monitor Patient 6's finger stick blood sugar checks on multiple home visits. 3. provided Patient 6 with home health aide visits two times per week. 4. ensure Patient 6 received the ordered medical social worker (MSW) evaluation. Patient 7: The HHA failed to perform a complete Skilled Nursing assessment. Patient 8: The HHA failed to perform a complete Skilled Nursing assessment. Patient 9: The HHA failed to: 1. monitor Patient 9's O2 sat on multiple home visits. 2. monitor Patient 9's finger stick blood sugar checks on two home visits. 3. provide skilled nursing visits two times per week as ordered by the physician. These Agency failures had the potential for Patients 1, 2, 3, 5, 6, 7, 8 and 9 not to achieve established health care goals and increased the risk of hospitalization. In addition, these failures had the potential to negatively impact the continuity, safety, and quality of patient care. Findings: During a review of the agency's policy and procedure titled, "Monitoring Patient's Response/Reporting to Physician", revised 4/18, indicated, "The patient's physician will be contacted on the same day when any of the following occur ...When there is any problem implementing the plan of care ...When a visit is missed for any reason ...All conferences or attempts to communicate with the physician will be documented in the clinical record." Patient 1: 1. The Department received a confidential complaint, alleging the HHA did not provide an adequate amount and the appropriate type and size of ostomy supplies to Patient 1 while receiving care and services from the HHA. During an interview on 12/10/19, at 10:09 a.m., with Patient 1's family member (FM), the FM stated Patient 1 and the family were not satisfied with the care provided by the HHA. The FM stated the HHA did not have the necessary ostomy supplies and only provided what the HHA had on hand and not what was needed to meet Patient 1's ostomy needs and the ostomy supplies the HHA provided were incomplete and came in an opened packaging. The FM stated at times Patient 1 had to use tape and regular plastic bag, because the HHA did not provide enough ostomy supplies. The FM stated, "We were extremely not satisfied with their (HHA) care, especially with the ostomy supplies." During a review of Patient 1's POCs dated 6/19/19 to 8/17/19 and 8/18/19 to 10/16/19 the POCs indicated, in part, Patient 1 had an ostomy and required ostomy supplies. During an interview on 11/25/19, at 12:45 p.m., with the Director of Patient Care Services (DPCS), the DPCS stated, "If patient receives regular wound care or ostomy care, supplies are provided by us (HHA)." During a concurrent interview and record review on 11/25/19, at 1:16 p.m., with the Referral Intake Coordinator (RIC) of Patient 1's clinical record and available invoices for the ostomy supplies provided to Patient 1 during the time period Patient 1 was on care with the HHA (from 6/19 to 10/14/19). The invoices indicated there was inconsistency with the provision of ostomy supplies to Patient 1. The RIC stated, "Apparently, patient (Patient 1) had issues with adhesiveness of the supplies. From June to August (2019), whatever we had in the stockroom was provided to her to try, but we don't have any paper record of what exactly was provided." Review of Patient 1's Skilled Nursing Visit (SNV) Note dated 7/7/19, the SNV Note indicated, "Advised patient to contact (name of the HHA) office tomorrow regarding resupply of ostomy bags and other materials needed for ostomy." The clinical record did not have any documentation the identified problem with lack of ostomy supplies was resolved. Review of Patient 1's SNV Note dated 8/17/19, the SNV Note indicated, "Instructed patient ...to contact (name of HHA) Monday morning regarding ostomy supplies. Patient states she is very dissatisfied with the runaround regarding supplies." The clinical record did not have any documentation Patient 1's dissatisfaction was addressed and resolved. Review of Patient 1's SNV Note dated 8/31/19, the SNV Note indicated, "Patient states she is very dissatisfied with the runaround regarding supplies but she appreciates SN (Skilled Nursing) visits and knows that finding an oncology nurse (specialized nurse who cares for cancer patients) to provide home services is difficult." The clinical record did not have any documentation Patient 1's dissatisfaction was addressed and resolved. Review of Patient 1's SNV Note dated 9/14/19, the SNV Note indicated, Patient 1 was assessed to be "Agitated" with comments "Patient is upset regarding ostomy supplies being not complete." During an interview on 1/30/20, at 11:37 a.m., with the RIC, the RIC confirmed there was inconsistency with ostomy supplies provided to Patient 1. The RIC confirmed the HHA is required to provide ostomy supplies to meet the needs of a patient. The RIC indicated Patient 1 had a problem with ostomy supplies due to the stoma (opening) location and required more than usual of ostomy supplies. 2. During a review of Patient 1's supplemental physician order dated 6/24/19 indicated, a change of visit frequency was ordered and Patient 1 was ordered to be visited twice per week, every other week, starting 6/30/19. Review of a supplemental physician order, dated 6/26/19, the order indicated an extra nursing visit was to be made from 6/26/19 to 6/29/19. During a review of Patient 1's nursing notes and communication notes, the notes indicated, Patient 1 was visited only once from 6/30/19 to 7/6/19, instead of the ordered two times. The clinical record also indicated the HHA did not make the extra nursing visit from 6/26/19 to 6/29/19 as ordered. During an interview on 1/30/20, at 12:33 p.m., with the Clinical Supervisor 1 (CS1) and the RIC, the CS1 and RIC confirmed Patient 1 was visited only once from 6/30/19 to 7/6/19, and confirmed the extra nursing visit was not made from 6/26/19 to 6/29/19, as ordered. The CS1 and the RIC also confirmed the ordered visit frequency must be followed and confirmed it was not. 3. During a review of Patient 1's POC dated 6/19/19 to 8/17/19, the POC indicated, in part, Patient 1 was diagnosed with Diabetes Mellitus (chronic condition that affects the way the body processes blood sugar) and was ordered to be admitted to HHA for "IV administration (administration of medications through a vein), ostomy care." The POC indicated the HHA needs to notify a physician if Patient 1 has elevated or lowered temperature (greater than 101 degrees or less than 97), elevated or lowered blood pressure (more than 160/100 or less than 95/49), elevated or lowered blood sugar (fasting blood sugar (tested on an empty stomach) greater than 105 or less than 80; random blood sugar (tested randomly and not on an empty stomach) greater than 150 and less than 90), increased or decreased weight (greater than 150 or less than 130). The POC indicated, "SN (Skilled Nurse) to assess pain level and effectiveness of pain medications and current pain management therapy every visit ...SN to report to physician if patient experiences pain level not acceptable to patient, pain level greater than 4 (on a scale zero to ten), pain medications not effective, patient unable to tolerate pain medications, pain affecting ability to perform patient's normal activities. SN to instruct Patient/Caregiver on wound care as follows: remove ostomy appliance, remove visible stool, clean with baby wipe, apply stomahesive (skin barrier) wipe and stomahesive powder, reapply appliance (device that provides a means for the collection of body waste) daily and PRN (as needed for) leakage. SN to assess skin for breakdown every visit." Review of Patient 1's POC dated 8/18/19 to 10/16/19, the POC indicated, in part, Patient 1 had a diagnosis of Diabetes Mellitus, had on ostomy and required ostomy supplies. The POC indicated "Assessment of ...Type 2 diabetes mellitus (with this type of diabetes, the body either doesn't produce enough insulin, which is a hormone produced in the pancreas, or it resists insulin) ...Notify physician of ...O2 Sat (oxygen saturation - blood oxygen level) less than (<) 92%. SN to assess pain level and effectiveness of pain medications and current pain management therapy every visit. SN to instruct patient to take pain medication before pain becomes severe to achieve better pain control. SN to assess skin for breakdown every visit. SN to instruct patient/caregiver on ostomy management as follows: change bag daily and assess site for issues ..." During an interview on 12/11/19, at 4:24 p.m., with the Director of Patient Care Services (DPCS), the DPCS indicated even though the HHA's POCs do not specify for nurses to assess patients' all body systems, it is still required and expected for all body systems to be assessed every visit. During a review of Patient 1's Start of Care Comprehensive Assessment dated 6/19/19, the Assessment indicated, Patient 1 was assessed to have "constant, achy" pain and was taking pain medication Hydrocodone (narcotic used for moderate to severe pain) one tablet every 8 hours, and indicated "Relief rating of pain, i.e., pain level after medications: 4 (on a scale zero to ten) ...Medication effectiveness: does not take pain completely ...Frequency of pain interfering with patient's activity or movement: all of the time." Review of Patient 1's SNV Notes dated 6/20/19 through 8/29/19, the SNV Notes indicated, the assessments of blood sugar, weight, and pain level were not completed and left blank. Review of Patient 1's SNV Note dated 8/3/19, the SNV Note indicated, the assessments of blood sugar, weight, cardiovascular system (assessment of chest pain, heart sounds, pulses, swelling, etc.), respiratory system (such as assessment of lung sounds, cough, shortness of breath, etc.), sensory system (assessment of hearing, vision, etc.), genitourinary system (assessment of any problems with urination or in the genitalia), musculoskeletal system (assessment of mobility, weakness, joint stiffness, etc.), psychosocial status (assessment of home environment, coping skills, mood, ability to make decisions, behavior, etc.), ostomy, and pain level at the time of the visit were not filled out and were left blank. During an interview on 1/30/20, at 1:29 p.m., with the CS1 and the RIC, the CS1 confirmed nurses are expected to assess all body systems every visit. The CS1 also confirmed the blood sugar, weight, and pain level should have been assessed and documented. The CS1 also confirmed blood sugar, weight, all body systems, ostomy, and pain level at the time of the visit should have been assessed and documented, and confirmed they were not. Patient 2: 1. During a review of Patient 2's supplemental physician order, dated 11/20/19, the physician's order indicated, an additional nursing visit was ordered to be made on 11/20/19. Review of a supplemental physician order, dated 12/05/19, indicated a change of visit frequency was ordered and Patient 2 was ordered to be visited twice a week for three weeks starting 12/05/19. During a review of Patient 2's nursing notes and communication notes, indicated the HHA did not make the extra visit on 11/20/19, as ordered. The clinical record also indicated Patient 2 was visited only twice from 12/01/19 to 12/07/19, instead of the ordered three times. During an interview on 1/30/20, at 2:46 p.m., with the Medical Director (MD), the MD confirmed Patient 2's visit frequencies were not followed as ordered. 2. During a review of Patient 2's POC dated 10/30 to 12/28/19, the POC indicated, Patient 2 was admitted to the HHA for "Aftercare following surgery for neoplasm (new and abnormal growth of tissue in some part of the body, especially as a characteristic of cancer), encounter for change or removal of drains (removal of fluid or other material from a wound or body cavity), malignant (refers to cancer cells that can invade and kill nearby tissue and spread to other parts of the body) neoplasm of tongue, unspecified encounter for attention to tracheostomy (incision in the windpipe made to relieve an obstruction to breathing), encounter for attention to gastrostomy (opening into the stomach from the abdominal wall, made surgically for the introduction of food). The POC indicated for the HHA to notify Patient 2's physician in case of elevated or lowered blood pressure ([BP] a measure of the force your heart uses to pump blood around your body) greater than 160/90 or lower than 90/50 and lowered O2 Sat (less than 94%). The POC indicated "SN (Skilled Nurse) to assess pain level and effectiveness of pain medications and current pain management therapy every visit.., SN to report to physician if patient experiences pain level not acceptable to patient, pain level greater than 6, pain medications not effective, patient unable to tolerate pain medications, pain affecting ability to perform patient's normal activities ...SN to assess/evaluate wound(s) at each dressing change and PRN (as needed) for signs/symptoms of infection." During an interview on 12/11/19, at 4:24 p.m., with the Director of Patient Care Services (DPCS), the DPCS indicated even though the HHA's POCs do not specify for nurses to assess patients' all body systems, it is still required and expected for all body systems to be assessed every visit. Review of Patient 2's Start of Care Comprehensive Assessment, dated 10/30/19, the Assessment indicated, Patient 2 was assessed to have three wounds. According to the assessment, Wound #1 was a surgical wound, located on the left side of the neck, open and required no wound care, with wound pain of 4 (on a scale zero to ten). Wound #2 was a surgical wound located on the left forearm, open, with wound pain of 4, and required wound care treatment. Wound #3 was a surgical graft site (surgical procedure where a section of skin is removed from an uninjured area and placed on the site of the injury) wound located on the upper left thigh, open and required no wound care, with wound pain of 4." 2a. Review of Patient 2's SNV Notes dated 10/31/19 and 11/2/19, indicated the assessments of blood pressure, O2 Sat (oxygen saturation - blood oxygen level) and pain level at the time of the visit were not completed and left blank. The note was missing an assessment of two of Patient 2's wounds (on the left side of the neck and on the left thigh). Review of SNV Notes dated 11/03/19 through 12/7/19 indicated the assessments of O2 Sats were not completed and left blank. During an interview on 1/30/20, at 3:39 p.m., with the MD, the MD confirmed the notes were missing parts of the assessments. The MD also confirmed the above assessments should have been done and documented. 2b. During an observation on 12/11/19, at 12:42 p.m., a Skilled Nurse (SN1) failed to assess every body system for Patient 2 and did not assess the gastrostomy site (a surgical opening into the stomach), hand grip strength (weak or unequal hand grip could indicate potential problem with health), and capillary refills (test done on the nail beds and is used to assess for the amount of blood flow to tissue). During an interview on 12/11/19, at 1:33 p.m. with SN1, the SN1 confirmed she is required to follow the POC and required to assess all body systems during each visit. SN1 confirmed she failed to assess all body systems for Patient 2 during the home visit on 12/11/19. During an interview on 12/11/19, at 4:46 p.m., with the Medical Director (MD) and the Director of Patient Care Services (DPCS), the MD and DPCS confirmed all nurses are expected to follow the POCs and are expected to perform complete assessments of all body systems every visit. Patient 3: During a review of Patient 3's Plan of Care (POC) dated 10/26/19 to 12/24/19, the POC indicated, Patient 3 was admitted to the HHA for "dressing change, medication management, general assessment". POC also indicated "Notify physician of ...O2(oxygen) Sat (saturation) less than (<) 94%...SN to assess for changes in neurological status (mental status, pupils, motor and sensory function) every visit ..." During an interview on 12/11/19, at 4:24 p.m., with the Director of Patient Care Services (DPCS), the DPCS indicated even though the Home Health Agency's (HHA) POC does not specify for nurses to assess all patients' body systems, it is still required and expected for all body systems to be assessed every visit. 1a. During an observation on 12/11/19, at 6:45 p.m., at Patient 3's home, SN2 failed to assess all body systems for Patient 3 and did not assess O2 Sat, pupils, hand grip strength, the genitourinary system (such as any problem with genital or urination), peripheral pulses (on hands and legs), capillary refills, and did not assess the lower extremities for edema (swelling). During an interview on 12/11/19, at 7:48 p.m., with SN2, the SN2 confirmed she is required to follow the POC and perform a complete body assessment every visit. LVN 1 confirmed she did not assess all body systems for Patient 3 during the home visit on 12/11/19. During an interview on 1/30/20, at 3:56 p.m., with the Medical Director (MD), the MD confirmed nurses are expected to perform complete assessments of all body systems every visit. 1b. Record review of SNV Notes dated 11/9/19 through 12/14/19 indicated the O2 Sat assessment was not completed and left blank. During an interview on 1/30/20, at 4:09 p.m. with the MD, the MD confirmed the notes were missing the assessment of O2 Sat. According to "Fundamentals of Nursing - 7th Edition", (Potter and Perry; 2009), "Nurses follow physicians' orders unless they believe the orders are in error or harm clients. Therefore you need to assess all orders, and if you find one to be erroneous or harmful, further clarification from the physician is necessary." A review of the agency policy and procedure titled, "Care Planning Process," dated April 2018, indicated, "Clinicians will inform the patient's physician of any changes that suggest a need to alter the plan of care. Changes must be written, dated, and signed by the professional making the changes ...Problems and/or needs related to patient's ... desires, ...will be included in the plan of care." Patient 5: During a review of the "Home Health Certification and Plan of Care" (POC) for Patient 5, dated 11/14/20, the POC indicated, orders for Skilled Nursing Visits (SNV) effective "11/15/20 2w1 (2 times per week for 1 week)." Further review of the POC, indicated orders for Speech Therapist (ST) effective "11/14/20 1wk1 (1 time per week for 1 week)." During a review of the SNV Notes section of the Medical Record for Patient 5, no documentation of a second visit was found during the week of 11/15/20 and no communication notes indicating the Physician was notified of the missed visit. During a review of the ST section of the Medical Record for Patient 5, no documentation was found indicating the ST evaluation completed. During an interview on 1/14/21, at 3:30 p.m., with the clinical supervisor (CS2), the CS2 acknowledged no second SNV occurred during the week of 11/15/20. The CS2 further the Physician was not notified of the missed visit. The CS2 confirmed a ST evaluation not completed per physician orders. Patient 6: During a review of the "Home Health Certification and Plan of Care" (POC) for Patient 6, dated 11/10/20, the POC indicated Patient 6 was admitted to the HHA with diagnoses including, but not limited to, malignant neoplasm (cancer) of pancreas (an organ in the abdomen that helps in digestion and regulates blood sugar), type 2 diabetes, essential hypertension (high blood pressure) and anemia (a condition where there is a lack of enough healthy red blood cells to carry adequate oxygen to the body's tissues). The POC further indicated the following MD orders: "SN (skilled nursing) to assess O2 saturation on room air freq (frequency) Q (every) VISIT." "SN to perform finger stick for fasting blood sugar/random blood sugar during visit if it has not been done ..." "Home Health Aide freq 2xW (two times per week for assistance with ADLs/IADLs (activities of daily living/independent activities of daily living)." 1. During a review of the SNV Notes for Patient 6, dated 11/17/20, 11/24/20, 12/11/20 and 12/17/20, the SNV Notes indicated O2 saturations were not documented as completed. During a concurrent record review and interview on 1/14/21, at 2:50 p.m., with the clinical supervisor (CS2), the CS2 confirmed O2 saturations not documented and should have been. 2. During a review of the SNV Notes for Patient 6, dated 11/17/20, 11/24/20, 12/3/20, and 12/11/20, the SNV Notes indicated blood sugar levels were not documented as having been completed by the agency staff or by Patient 6 or Patient 6's caregiver. During a concurrent record review and interview on 1/14/21, at 2:50 p.m., with the clinical supervisor (CS2), the CS2 acknowledged there was no documentation of blood sugar levels. The CS2 further stated SN should have documented a blood sugar on the nursing notes whether it was done by patient/patient caregiver or the SN. 3. During a review of Patient 6's medical record (MR), the MR indicated, there were no home health aide (HHA) visits between 11/10/20 and 12/24/20. The MR further indicated, a communication noted dated 11/12/20 from the intake coordinator, "Per visiting nurse patient declined HHA services at this time." There was no documentation in the MR that Patient 6's physician had been notified of the patient's decline of service or orders to discontinue the service for HHA visits. During a concurrent record review and interview on 1/14/21 at 2:50 p.m., with CS2, the CS2 confirmed the HHA visits were not done per physician orders and the physician was not notified for a discontinuation order. 4.During a review of a SNV Note for Patient 6, dated 12/3/20, the SNV Note indicated, "family requesting MSW (medical social worker) for community resources to support primary caregiver." Further review of Patient 6's MR indicated, that as of 12/24/20, there was no documentation from the MSW that a visit was made or attempted. During a concurrent record review and interview on 1/14/21, at 2:50 p.m., with the clinical supervisor (CS2), the CS2 confirmed there was no MSW documentation in the medical record. The CS2 was unable to explain why visit had not occurred. Patient 7: During a review of Patient 7's SNV Note dated 11/13/20, the SNV Note indicated, vital signs, blood sugar, and last bowel movement (bm) were not completed. Patient 8: During a review of Patient 8's SNV Note dated 11/2/20 the SNV Note indicated, a genitourinary assessment was not completed and a blood sugar was not taken or documented that the patient took it and what the result was. During a review of Patient 8's SNV Note dated 11/10/20, the SNV Note indicated, a blood sugar level and a date of the patient's last bm was not documented. During a review of Patient 8's SNV Note dated 11/27/20, the SNV Note indicated, Patient 8 reported a blood sugar of 67 and Patient 8 ate a hard candy. Patient 8 stated he did not recheck his blood sugar after eating the candy. The Skilled Nurse (SN) advised the patient to recheck the blood sugar. There was no documentation the patient rechecked the blood sugar or that the SN checked it during the visit. During an interview on 1/21/21 at 2:15 p.m. with the CS2, the CS2 stated Patient 7's vital signs, blood sugar and last bm should have been documented. Additionally the CS2 stated the SN should have rechecked or had Patient 8 recheck the blood glucose after eating the candy. Patient 9: During a review of the POC for Patient 9, dated 8/15/20, the POC indicated, the following physician orders: "SN to assess O2 saturation on room air Q VISIT." "SN to perform finger stick for fasting blood sugar/random blood sugar during visit if it has not been done ..." "Skilled Nursing Visits two times per week for 9 weeks, effective 8/16/20. 1. During a review of the "Skilled Nursing Visit" (SNV) Notes for Patient 9, dated 8/21/20, 8/28/20, 9/4/20, 9/18/20, 9/25/20 and 10/2/20, the SNV notes indicated, O2 saturations were not documented as completed. During a concurrent record review and interview on 1/14/21, at 2:05 p.m., with the CS2, the CS2 confirmed O2 saturations were not documented and should have been. 2. During a review of the SNV Notes for Patient 9, dated 9/25/20 and 10/2/20, the SNV Notes indicated, blood sugar levels were not documented as having been completed by agency staff or by Patient 9/caregiver. During a concurrent record review and interview on 1/14/21, at 2:05 p.m., with the CS2, the CS2 acknowledged there was no documentation of assessment of Patient 9's blood sugar levels and should have been. 3. During a review of Patient 9's MR, the MR indicated, there was only one skilled nursing visit per week between 8/15/20 and 9/5/20 and again between 9/13/20 and 10/10/20. Further review of the MR, a communication note, dated 8/25/20 indicated, "Pt [patient] requested SN [skilled nursing] visit only one time per week." There was no documentation in the MR that the physician acknowledged patient's decline of service or orders to modify the SNVs to one time per week. During a concurrent record review and interview on 1/14/21, at 2:05 p.m., with the CS2, the CS2 confirmed skilled nursing visits were not done per physician orders and there was no physician order to change the frequency of SNV.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on record review, interview, and observation, the Home Health Agency (HHA) failed to provide the necessary patient/caregiver education to four of ten sampled patients (Patients 1, 2, 3 and 6) as ordered by the physicians. Patient 1: Patient 1 did not receive education on ileostomy ([ostomy]an opening into the ileum, part of the small intestine, from the outside of the body; an ileostomy provides a new path for waste material to leave the body after part of the intestine has been removed) management, peripheral IV line (a small, short, plastic tube, called a catheter which is inserted into a vein for administration of medications), central line port (a type of central venous catheter, which is a tube that goes into a vein in the chest for fluids and medications), precautions for high-risk medications, etc. Patient 2: Patient 2 did not receive education on the importance of receiving influenza (a highly contagious viral infection of the respiratory passages causing fever and severe aching) and pneumococcal (bacterial infections that can affect the lungs and other parts of the body) vaccines (biological preparation that provides immunity to a specific disease), pain management, signs and symptoms of wound infection, and care of PEG tube (percutaneous endoscopic gastrostomy - is a medical procedure in which a tube is passed into the stomach through the abdominal wall, most commonly to provide a means of feeding when oral intake is not adequate). Patient 3: Patient 3 did not receive education on the importance of receiving influenza and pneumococcal vaccines, UTI (urinary tract infection - infection in any part of the urinary system, such as kidneys, ureters, bladder and urethra), and care of PEG tube. Patient 6: Patient 6 did not receive education on the specific diet type ordered. Failure to provide education to patients/caregivers about patients' specific health needs placed Patients 1, 2, 3 and 6 at risk for adverse consequences which may result in compromised health and an increase in hospitalizations. Findings: The HHA policy and procedure titled "Patient Education Process", revised 11/18, indicated, "Patients and family/caregivers will receive education in verbal, visual, and written format, as appropriate. The scope of teaching will be determined by assessing the needs, abilities, learning preferences, and readiness to learn of the patient and family/caregiver, as well as by the plan of care...Unless otherwise ordered by the physician (or other authorized licensed independent practitioner), the patient and family/caregiver will receive verbal and, as appropriate, written instructions that are in plain language that does not use medical abbreviations on: ... Medication management and administration Prescribed medications; Pain management; Infection prevention and control ...Documentation of patient and family/caregiver education will consist of: A. Describing what was taught to the patient (if using preprinted materials, document the name of the handout) B. Describing the patient's response to the teaching, including the level of understanding and the ability to repeat or demonstrate what was taught C. Describing any additional learning needs not currently met D. Describing teaching planned for subsequent visits ...Patient and family/caregiver education will be interdisciplinary, as appropriate to the plan of care ..." Patient 1: 1. During a review of Patient 1's plan of care (POC) dated 6/19/19 to 8/17/19, the POC indicated, Patient 1 was admitted to the HHA for "IV (intravenous - into a vein) administration, ostomy (ileostomy) care" with the following ordered services "SN (skilled nurse) to instruct patient/caregiver on ostomy management as follows: change bag daily and prn (as needed) leakage. Remove bag, remove any visible stool, clean around stoma (opening) with baby wipes, apply stomahesive (product used to protect the skin from irritating drainage), then apply stomahesive powder, remove excess powder. Cut hole in appliance to fit the stoma, apply clean appliance ...SN to instruct the Patient/Caregiver on precautions for high-risk medications ... During a review of Patient 1's Start of Care Comprehensive Assessment dated 6/19/19, the Assessment indicated, Patient 1 was assessed to have "constant" pain with the "frequency of pain interfering with activity or movement - all of the time". The Assessment also indicated Patient 1 had a peripheral intravenous line as well as a port, and required for the HHA nurses to teach Patient 1/caregiver on signs and symptoms of infection and infiltration (when fluid or medications leak into the surrounding tissue, instead of into a vein). Review of Patient 1's Skilled Nursing Visit (SNV) Notes dated 6/20/19 through 8/17/19, the SNV Note indicated, there was no documentation Patient 1/caregiver were educated about ostomy management and IV infection/infiltration. Review of Patient 1's SNV Note dated 6/21/19, the SNV Note indicated, there was no documentation Patient 1/caregiver were educated about ostomy management, IV infection/infiltration, and/or precautions for high-risk medications. The note also indicated Patient 1's caregiver reported problem with Patient 1's ostomy, "daughter states cutting hole for ostomy bag smaller did not work as stool leaked out around it; states bags are lasting her (Patient 1) approximately 1 day ..." The note did not contain any education provided to Patient 1's and her daughter about the reported problem and how it should be managed. Review of Patient 1's SNV Note dated 6/22/19, the SNV Note indicated, there was no documentation Patient 1/caregiver were educated about ostomy management. The note also did not contain any documentation Patient 1 and/or caregiver were assessed for the ability to properly perform ostomy care. During an interview on 1/30/20, at 1:32 p.m., with the CS and the RIC, the CS and RIC confirmed the notes were missing ostomy management education. The CS also confirmed Patient 1/caregiver were not educated at all about ostomy management during the entire certification period from 6/19 to 8/17/19 and confirmed it was a problem. The CS and RIC also confirmed the notes were missing patient specific and necessary education, as indicated in the POC such as IV infection/infiltration education and precautions for high-risk medication education and pain management as well as the education about the reported problem noted in SNV Note dated 6/22/19. 2. During a review of Patient 1's Comprehensive Reassessment dated 8/15/19, the Assessment indicated, Patient 1 was reassessed to have an ileostomy and still had the need for ileostomy management education. In addition, Patient 1 continued to have "constant" pain with the "frequency of pain interfering with activity or movement - all of the time". Review of Patient 1's POC dated 8/18/19 to 10/16/19, the POC indicated, "SN to instruct patient/caregiver on ostomy management as follows: change bag daily and assess site for issues..." Review of Patient 1's SVN Notes dated 8/29/19 through 10/10/19, the SNV Notes indicated, there was no documentation Patient 1/caregiver were educated about ostomy management. During an interview with the MD, on 1/30/20, at 2:37 p.m., the MD reviewed Patient 1's medical record and confirmed the notes were missing ostomy management education. The MD also confirmed Patient 1/caregiver were not educated at all about ostomy management during the entire recertification period from 8/18 to 10/16/19. Patient 2: 1. During a review of Patient 2's Plan of Care (POC) dated 10/30 to 12/28/19, the POC indicated, "SN (skilled nurse) to instruct patient on importance of receiving influenza and pneumococcal vaccines...SN to instruct patient to take pain medication before pain becomes severe to achieve better pain control. SN to instruct patient on nonpharmacologic pain relief measures including relaxation techniques, massage, stretching, positioning, and/or hot/cold packs ...SN to instruct patient/caregiver on wound care ...SN to instruct the Patient/Caregiver on signs/symptoms of wound infection to report to physician ...SN to instruct caregiver on proper suctioning technique. SN to instruct the Patient/Caregiver on methods to recognize pulmonary (relating to the lungs) dysfunction and relieve complications. SN to instruct the patient the following symptoms could be signs of a heart attack: chest discomfort in one or both arms, back, jaw, stomach, shortness of breath, cold sweat, nausea, or dizziness. Instruct patient on signs and symptoms that necessitate calling 911. SN to instruct the Patient/Caregiver on signs/symptoms of UTI, to include pain, foul odor, cloudy or blood-tinged urine and fever ...SN to instruct the Patient/Caregiver on enteral nutrition (a way to provide food through a tube placed in the nose, the stomach, or the small intestine). SN to instruct the Patient/Caregiver on proper care of PEG SN to instruct the Patient/Caregiver to give 100 cc (cubic centimeters) of free water every PRN (as needed) ...SN to instruct patient to wear proper footwear when ambulating. SN to instruct patient to change positions slowly. SN to instruct the Patient/Caregiver on importance of adequate lighting in patient are. SN to instruct the Patient/Caregiver to contact agency to report any fall with or without minor injury and to all 911 for fall resulting in serious injury or causing severe pain or immobility." Review of Patient 2's Skilled Nursing Visit (SNV) Notes dated 11/03 and 11/8, the SNV Notes indicated, the visiting nurse did not provide any education to Patient 2 and/or his caregiver. Review of Patient 2's SNV Note dated 11/09/19, the SNV Note indicated, "Advised patient to change dressings on left arm or gtube (PEG) site if SN is not due for dressing change and it is needed." The note did not contain any education as specified in the POC. Review of Patient 2's SNV Note dated 11/10/19, the SNV Note indicated, "Encouraged patient to ask questions about wound care to MD (medical doctor) or SN so patient is up to date on orders if dressing needs to be changed by patient." The note did not contain any education as specified in the POC. During an interview on 1/30/20, at 3:35 p.m., with the Medical Director (MD), the MD confirmed the nurse should have educated Patient 2 and/or his caregiver according to the POC. Patient 3: 1. During a review of Patient 3's Plan of Care (POC) dated 10/26/19 to 12/24/19, the POC indicated, "SN to instruct patient on importance of receiving influenza and pneumococcal vaccines ...SN to instruct patient to take pain medication before pain becomes severe to achieve better pain control ...SN to instruct the Patient/Caregiver on signs/symptoms of wound infection to repot to physician ...SN to instruct the Patient/Caregiver on signs/symptoms of UTI to report to MD/SN ...SN to instruct the Patient/Caregiver on proper care of peg (percutaneous endoscopic gastrostomy - is a medical procedure in which a tube is passed into the stomach through the abdominal wall, most commonly to provide a means of feeding when oral intake is not adequate) ... SN to instruct patient to wear proper footwear when ambulating. SN to instruct patient to use prescribed assistive device when ambulating. SN to instruct patient to change positions slowly. SN to instruct patient to use non-skid mats in tub/shower. SN to instruct the Patient/Caregiver on importance of adequate lighting in patient area." During an observation on 12/11/19 at 6:45 p.m. a Skilled Nurse (SN 2) was observed to instruct Patient 3 and Patient 3's Family Member (FM who is also the caregiver) only to change the dressing over the PEG. SN 2 did not provide any other education during the visit as specified in the POC. During an interview on 12/11/19, at 7:28 p.m., with Patient 3's FM , the FM indicated the HHA nurses do not provide any education about how to properly do wound care. The FM simply observes how the nurses change the dressings and asks questions. During an interview on 12/11/19, at 7:48 p.m., with SN 2, the SN 2 confirmed it is expected to follow the POC when providing education to patients. During an interview on 1/30/20, at 3:56 p.m., with the MD, the MD confirmed nurses are expected to provide education in accordance with the POC. Patient 6 During a review of the "Physician's (MD) Orders" for Patient 6, dated 11/10/20, the MD Orders indicated, Nutritional Requirements (diet orders) "Low Sodium. Low Carbohydrate. No Concentrated Sweets." Further review of the MD orders, indicated, "SN to instruct Patient/Caregiver on LOW SODIUM, LOW CARB diet." During a review of the Skilled Nursing Visit (SNV) notes for Patient 6, dated 11/17/20, 11/24/20, 12/3/20, 12/11/20, and 12/17/20, the SNV Notes indicated, Patient 6 was eating a "Regular" diet. Further review of the SNV notes, of the same dates, indicated "Teachings done on...diet and nutrition..." The SNV Notes did not specify which diet type (regular or low sodium, low carb) education given or address education reminding Patient 6/Caregiver of diet ordered by the MD. During an interview on 1/14/20, at 2:50 p.m., with the clinical supervisor (CS2), the CS2 confirmed documentation on diet type did not follow MD orders. CS2 further stated, SN documentation on teaching of diet and nutrition should be more thorough.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the Home Health Agency (HHA) failed to communicate with the physicians for five of ten sampled patients (Patients 1, 2, 5, 6 and 10) related to: Patient 2: 1. The HHA did not notify the physician when Patient 2 was identified to consume regular foods by mouth, even though Patient 2 was admitted to the HHA with a gastrostomy tube (G-tube - medical device used to provide nutrition to people who cannot obtain nutrition by mouth, are unable to swallow safely, or need nutritional supplementation) and NPO (nothing by mouth) status. This failure resulted in the HHA not having a physician's confirmation ensuring the physician was aware of the newly identified situation, placing Patient 2 at risk for compromised health complications. 2. The HHA did not contact the physician regarding a speech therapy evaluation (done to find out if a person has communication or swallowing problems). 3. The HHA did not notify the physician when Patient 2 was unable to perform wound care by self and when Patient 2's family member (FM) was unwilling and unable to assist Patient 2 with the care needs related to wound care. These failures had the potential for Patient 2's health needs not being met. Patient 3: 1. The HHA did not notify the physician when Patient 3 did not follow the prescribed enteral nutrition (nutrition put through the gastrostomy tube) feeding frequency, as indicated in Patient 3's plan of care (POC). This failure had the potential for Patient 3's nutritional needs not being met. Patient 5: The Physician was not notified when Patient 5's diastolic (bottom number- amount of pressure in your arteries between beats) blood pressure ([BP]-a measure of the force that your heart uses to pump blood around your body) was outside of set parameters. Patient 6: The Agency did not notify the physician when Patient 6 was noted to have episodes of coughing when drinking thin liquids. These agency failures resulted in the physician not being aware of newly identified situations, and placing Patients 5 and 6 at risk for health complications. Patient 10: The HHA did not notify the physician or obtain an order for a Social Worker (SW) evaluation when it was documented, "Family needs additional help with patient's (Patient 10) care". In addition, the HHA did not follow through with an authorization for a referral for the SW. This failure placed Patient 10 at risk for not receiving needed care and Patient 10's family not receiving resources to care for Patient 10. Findings: Patient 2: 1. During a review of Patient 2's Start of Care Comprehensive Assessment, dated 10/30/19, indicated "Pt (Patient 2) had surgery for Ca (cancer) of the tongue with graft (a surgical operation in which a piece of healthy skin is transplanted to a new site on the body) from L (left) arm. Also had a tracheostomy (surgical incision in the windpipe made to relieve an obstruction to breathing) and insertion of a Gastric tube (G tube - a tube inserted through the abdomen that brings nutrition directly to the stomach) and skin graft from his L (left) thigh ...Elimination status ...NPO (nothing by mouth) ..." Review of Patient 2's Skilled Nursing Visit (SNV) Note dated 11/11/19, indicated Patient 2 was "NPO" and had "Dysphagia (difficulty swallowing)". The note also indicated "Pt (Patient 2) taking applesauce po (by mouth)". The clinical record did not have any documentation Patient 2's physician was notified that Patient 2 began consuming applesauce by mouth. During an interview on 1/30/20, at 3:22 p.m., with the Medical Director (MD), the MD confirmed the physician was not notified about Patient 2 consuming applesauce by mouth. Review of Patient 2's SNV Note dated 11/15/19, indicated "Patient is able to consume some applesauce and gently thickened products but primarily he is still using the PEG (percutaneous endoscopic gastrostomy - a tube inserted through the abdomen that brings nutrition directly to the stomach) for nutrition until released by physician. The clinical record did not have any documentation Patient 2's physician was notified regarding Patient 2 taking foods by mouth. The clinical record also did not have any documentation the HHA received a physician's clearance or physician's order for Patient 2 to consume foods by mouth. During an interview on 1/30/20, at 3:25 p.m., with the MD, the MD confirmed the physician was not notified about Patient 2 consuming foods by mouth. The MD also confirmed the HHA did not receive a physician's clearance or order for Patient 2 to consume foods by mouth. 2. During a review of Patient 2's SNV Note dated 11/11/19,the SNV Note indicated, "Pt (Patient 2) to follow up regarding swallow test (used to determine the cause of painful swallowing or difficulty with swallowing) in AM (morning). Request for ST (speech therapy)." The clinical record did not have any documentation the HHA notified Patient 2's physician about the "Request for ST". The clinical record also did not have any documentation about whether Patient 2 was actually evaluated by the ST and of the results of the evaluation. During an interview on 1/30/20, at 3:22 p.m., with the MD, the MD confirmed Patient 2's physician was not contacted about the request for the ST evaluation. The MD also confirmed Patient 2's clinical record did not have the results of the actual ST evaluation. 3. During a review of Patient 2's physician wound care order dated 10/30/19, indicated Patient 2 was prescribed daily wound care to the left forearm and indicated, "Change dressing every day. Patient/CG (caregiver) ok to complete wound care on non-nursing visit days." Review of Patient 2's physician's order dated 11/01/19, indicated Patient 2 was ordered to be visited by the HHA nurses three times a week from 11/10/19 to 11/23/19 and twice a week from 11/24/19 for five weeks. Review of Patient 2's SNV Note dated 11/11/19, indicated "Pt (Patient 2) able to change GT (G-tube) and trach (tracheostomy) dressing. Unable to change left forearm pt (Patient 2) states an awkward area to do on own ...FM is hands off and does not appear willing to get trained." The clinical record did not have any documentation Patient 2's physician was notified about Patient 2's inability to do wound care on his own and about Patient 2's FM not willing to participate. The clinical record also did not have any documentation explaining if Patient 2 had his wound care needs met on non-nursing visit days. During an interview on 1/30/20, at 3:22 p.m., with the MD, the MD confirmed Patient 2's physician was not notified about Patient 2's inability to do wound care on his own and about Patient 2's FM not willing to assist. The MD also confirmed Patient 2's clinical record did not have any documentation explaining if Patient 2 was actually receiving the prescribed daily wound care on non-nursing visit days. Review of Patient 2's SNV Note dated 11/15/19, indicated, "FM (Family Member) not able to help (Patient 2's name) with dressing changes. Suggest 3 days per week for dressing changes." The clinical record did not have any documentation Patient 2's physician was notified about Patient 2's FM's inability to assist Patient 2 with wound care and about the suggestion for Patient 2's wound care to be decreased to three times per week. During an interview on 1/30/20, at 3:25 p.m., with the MD, the MD confirmed Patient 2's physician was not notified about Patient 2's FM's inability to assist with wound care and about the suggestion to decrease Patient 2's wound care to three times per week. Patient 3: During a review of Patient 3's plan of care (POC) dated 10/26/19 to 12/24/19, indicated Patient 3 was prescribed enteral nutrition three times per day. Review of Patient 3's SNV Notes dated 11/09, 11/15, 11/22, 11/26, and 12/04/19, indicated Patient 3 was self-administering enteral nutrition feedings twice per day. The clinical record did not have any documentation Patient 3's physician was notified about Patient 3 not following the prescribed enteral nutrition frequency. During an interview on 1/30/20, from 4:02 p.m., with the MD, the MD confirmed Patient 3's physician was not notified about Patient 3 not following the prescribed enteral nutrition frequency. Patient 5: During a review of the Home Health Recertification and Plan of Care (POC), dated 11/14/20, the POC indicated, "Notify physician of:...Diastolic BP greater than (>)90 or less than (<) 50." During a review of the SNV Note dated 11/21/20, the SNV Note indicated, Patient 5's blood pressure was 109/50. No documentation was found indicating the physician was notified per orders. During an interview on 1/14/21, at 3:30 p.m., with the clinical supervisor (CS2), the CS2 agreed the diastolic blood pressure for Patient 5 was outside set parameters and there was no documentation the physician was notified. Patient 6: During a review of the SNV Note for Patient 6, dated 12/3/20, the SNV note indicated, "patient has episodes of coughing when drinking liquids. Discuss need for speech therapy for swallowing eval [evaluation] (exam done to assess for swallowing problems). Encouraged use of semisolid and cold liquids." During a review of the SNV Note for Patient 6, dated 12/11/20, the SNV Note indicated, "reinforced the use of thick fluids." During a concurrent record review and interview on 1/14/21, at 2:50 p.m., of Patient 6's MR including SNV notes, Communication Notes, and physician orders, with the clinical supervisor (CS2), the CS2 confirmed the physician was not notified of Patient 6's change in condition and a swallowing evaluation was not ordered. The CS2 further acknowledged the physician was not notified of the change in consistency of fluids and the HHA did not have orders to change Patient 5 to thickened fluids. Patient 10: During a review of Patient 10's SNV Notes dated 11/14/20 and 11/28/20 The SNV Notes indicated, "Family needs additional help with patient care. Awaiting authorization for referral to SW". During a review of Patient 10's SNV Note dated 12/11/20, the SNV Note indicated, "Still awaiting authorization for referral to SW". During an interview on 1/21/21 at 2:40 p.m. with the Clinical Supervisor 2, the CS2 confirmed Patient 10 never received a SW evaluation and there was no order for the evaluation. A review of the agency policy and procedure titled, "Monitoring Patient's Response/Reporting to Physician", dated April 2018 indicated, "The patient's physician will be contacted on the same day when any of the following occur: A. Changes in the patient's condition ..."

Supervision of home health aides CFR(s): 484.80(h) Standard: Supervision of home health aides. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the agency's Registered Nurse (RN) provided supervision to the Certified Home Health Aide (CHHA) to ensure quality of care and services provided for one of ten sampled patients (Patient 5). This agency failure had the potential for Patient 5 to receive substandard care. Findings: During a review of the Home Health Certification and Plan of Care (POC) for Patient 5, dated 11/14/20, the POC indicated, the start of care was 11/14/20 and the certification period for home health services was 11/14/20 to 1/12/21. The CHHA orders on the POC were effective 11/15/20 2w5 (two times per week for five weeks). During a review of the SNV with Aide Supervision" note, dated 11/24/20, the SNV with Aide Supervision note indicated, the HHA supervision form was not completed. During an interview on 1/14/20 at 3:30 p.m., with the CS2, the CS2 confirmed the CHHA supervision form was incomplete and should have been fully completed.