Angels on Earth Home Health Inc.

“Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This Condition is not met as evidenced by: The agency failed to ensure that the Condition of Participation: G680 484.70: Infection prevention and control was in compliance when: a Registered Nurse (Registered Nurse 1 – RN 1) used a glucometer (a device used to test blood sugar levels) on Patient 3 but the glucometer belonged to another patient and was not to be used on multiple patients per the manufacturer’s instructions. (Refer to G682) 2. Registered Nurse 1 used a glucometer he was not trained to use while asking Patient 3’s caregiver on instructions on how to use it. (Refer to G682) 3. A staff member inappropriately disposed of biohazardous materials when 30 milliliters (mls – unit of measure) of liquid drained from a pleural catheter (a flexible tube that drains excess fluid from the space around the lungs) and the tubing used to drain the catheter were placed in a regular trash bag for disposal. (Refer to G682) The cumulative effect of these systemic practices had the potential to result in increased risk for the transmission of infectious disease amongst the facility’s patients. .”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on interview, and record review, the facility failed to notify the physician, as indicated in the facility’s policy and procedure (P&P), regarding Patient 1’s missed skilled nursing visits on October 15, 2024, October 18, 2024, and October 22, 2024. This failure resulted in the physician to be unaware of the missed visits and for the physician to not have an opportunity to provide additional orders for any potentially unmet care needs for Patient 1. Findings: A review of Patient 1’s “Patient Demographics” (a document which provides medical and demographic information), undated, indicated Patient 1 had a start of care date of October 8, 2024, and diagnoses which included pleural effusion (a buildup of fluid between the layers of tissue that line the lungs and chest cavity, congestive heart failure (a life-threatening condition that occurs when the heart can’t pump enough blood throughout the body), and diabetes mellitus (a condition In which the body can’t regulate blood sugars well and causes elevated blood sugar levels). During a review of Patient 1’s “Home Health Certification and Plan of Care,” with a certification period of October 8, 2024, to December 6, 2024, the plan of care indicated a physician’s order for skilled nursing visits to occur two times each week for a total of four weeks. Further review of the “Home Health Certification and Plan of Care,” indicated at each visit, the nurse was supposed to change the dressing of the Patient 1’s pleural catheter (a flexible tube that drains excess fluid from the space around the lungs), assess Patient 1’s for signs and symptoms of infection and complications associated with the pleural catheter, and drain the pleural catheter and record the amount of drainage each visit. During a review of Patient 1’s Electronic Health Record (EHR – an electronic medical record), the EHR indicated Patient 1 had missed skilled nursing visits on October 15, 2024, October 18, 2024, and October 22, 2024. There was no documented evidence in Patient 1’s EHR which indicated the physician was made aware of the missed visits. During a concurrent interview, and record review on November 20, 2024, at 2:24 PM, with the Office Manager (OM), the OM stated the facility’s Clinical Care Coordinator (CCC) was the individual who notified patient physicians of missed visits. The OM further stated the CCC would input a note in the electronic health record of the patient who had a missed visit which would indicate the MD was made aware. The OM reviewed Patient 1’s EHR and stated there was no evidence a physician was made aware of Patient 1’s missed visits on October 15, 2024, October 18, 2024, and October 22, 2024. During an interview on November 20, 2024, at 2:34 PM, with the Assistant Administrator (ASST ADMIN), the ASST ADMIN stated Patient 1 did not have any documentation in the EHR to indicate the physician was made aware of Patient 1’s missed visits in October 2024 (October 15, 2024, October 18, 2024, and October 22, 2024). During a concurrent interview, and record review on November 20, 2024, at 2:36 pm, with the ASST ADMIN, the facility’s policy and procedure (P&P) titled, “Missed Visits,” dated April 2017, was reviewed. The policy indicated, “Purpose – to ensure that missed visits are documented and does not affect the quality of patient care. Missed visits will be communicated to the clinical supervisor and the patient’s physician…A. Notify the physician and clinical supervisor of the missed visit and reason for missed visit. B. Document in the patient’s clinical record the following information:…4. Description of any unmet needs and how the patient’s needs were met. 5. Physician notification including date, time, physician name, method of notification and the staff reporting the information…” The ASST ADMIN stated the facility’s P&P was not followed. During a review of the facility’s P&P titled, “Monitoring Patient’s Response/Reporting to Physician,” dated April 2017, the policy indicated, “Purpose – To provide guidelines for monitoring the patient’s conditions, response to care and for reporting to the patient’s physician…3. The patient’s physician will be contacted on the same day when any of the following occur:…G. When a visit is missed for any reason…””

“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 facility failed to ensure it implemented its infection control program when: 1) A Registered Nurse (Registered Nurse 1 – RN 1) used a glucometer (a device used to test blood sugar levels) on Patient 3 but the glucometer belonged to another patient and was not to be used on multiple patients per the manufacturer’s instructions. This failure resulted in increased risk for the direct transmission of blood-borne diseases from one patient (the patient whose glucometer was used) to Patient 3. 2) Registered Nurse 1 used a glucometer he was not trained to use while asking Patient 3’s caregiver on instructions on how to use it. This failure resulted in RN 1 to use a glucometer on Patient 3 which RN 1 was not familiar with the device manufacturers instructions for its use, and cleaning and disinfecting which increased the risk of transmission of blood-borne diseases to Patient 3. 3) A staff member (Director of Patient Care Services – DPCS) inappropriately disposed of biohazardous materials when 30 milliliters (mls – unit of measure) of liquid drained from a pleural catheter (a flexible tube that drains excess fluid from the space around the lungs) and the tubing used to drain the catheter were placed in a regular trash bag for disposal. This failure resulted in the facility to be out of compliance with their policies and procedures (P&P) for biohazardous material disposition and had the potential to spread infections. Findings: 1) A review of Patient 3’s “Patient Demographics” (a document which provides medical and demographic information), undated, indicated Patient 3 had a start of care date of September 9, 2024, and diagnoses which included acute respiratory failure (a medical condition that occurs when the body’s respiratory system can’t provide enough oxygen to the blood or remove enough carbon dioxide from the body) and diabetes mellitus (a condition In which the body can’t regulate blood sugars well and causes elevated blood sugar levels). During an interview on November 19, 2024, at 5:15 PM, with Registered Nurse 1 (RN 1), RN 1 asked Patient 3 and Patient 3’s Caregiver (CG 3), if Patient 3 checks his blood sugar. CG 3 stated Patient 3 was not checking his blood sugar but they had an upcoming doctor’s appointment and were going to get instructions on what interventions they were supposed to do at that time to manage Patient 3’s diabetes mellitus. During a concurrent observation, and interview on November 19, 2024, at 5:30 PM, with RN 1, RN 1 asked Patient 3 and Patient 3’s CG 3, if Patient 3 had a glucometer (a device used to test blood sugar levels). CG 3 stated Patient 3 did not have a glucometer, but the facility had a glucometer which belonged to another patient. RN 1 stated “Ok I’ll just clean it first.” CG 3 then gave RN 1 a glucometer (brand name 1) in a zipper pouch which had the name of another patient on it. RN 1 used the glucometer from the zipper pouch and cleaned it (the glucometer) as well as a lancing device (a device used to prick the finger to obtain a small blood sample) with an alcohol wipe. RN 1 then used the glucometer and lancing device to test Patient 3’s blood sugar level. During an interview on November 19, 2024, at 5:43 PM, with RN 1, RN 1 stated the glucometer used on Patient 3 belonged to another patient in the facility. RN 1 further stated he did not know if the glucometer was able to be used on multiple patients or if it was intended to only be used by the patient it was assigned to. During an interview on November 22, 2024, at 8:45 AM, with the Director of Patient Care Services (DPCS), the DPCS stated RN 1 should not have used the glucometer of another patient to check Patient 3’s blood sugar because of the risk of transmission of bloodborne diseases. During a review of (Brand name) glucometer’s operators manual titled, “(Brand name) Self-Monitoring Blood Glucose System,” (undated), the operators manual indicated, “…The (brand name) Self-Monitoring Blood Glucose System is intended to be used by a single person and not to be shared….IMPORTANT INFORMATION…The (brand name) Self-Monitoring Blood Glucose System is for one person use ONLY. DO NOT share your meter or lancing device with anyone, including family members. Do not use on multiple patients!! – All parts of your blood glucose monitoring system could carry blood-borne pathogens [diseases] after use, even after cleaning and disinfecting. – Cleaning and disinfecting the lancing device and the meter destroys most, but not necessarily all, blood-borne pathogens…” During a review of the facility’s policy and procedure (P&P) titled, “Standard Precautions,” dated April 2017, the policy indicated, “Purpose – To reduce the risk of exposure to and transmission of infections when caring for patients. Policy -Organization personnel will adhere to the following precautions…Under standard precautions, blood and certain body fluids of all patients are considered potentially infectious for bloodborne pathogens, such as human immunodeficiency virus (HIV), and Hepatitis B virus (HBV). 2) During a concurrent observation, and interview on November 19, 2024, at 5:30 PM, with Registered Nurse 1 (RN 1), RN 1 was using a glucometer to check Patient 3’s blood sugar level when RN 1 stated, “I’ve never used this kind before,” (referring to the glucometer) and asked Patient 3’s caregiver (CG 3) if CG 3 knew how to use the glucometer. RN 1 then cleaned the glucometer and lancing device with an alcohol wipe and CG 3 gave RN 1 instructions on how to load the lancing device and use the glucometer. Following the instructions, RN 1 stated “so I do it like this?” as he used the glucometer to check Patient 3’s blood sugar. During an interview on November 22, 2024, at 9:02 AM, with the Director of Patient Care Services (DPCS), the DPCS stated if an RN is not familiar with how to use a specific type of device or glucometer, they were expected to call the office to get instructions on what to do and should not use the glucometer if they are not sure how to use it. During a review of (Brand name) glucometer’s operators manual titled, “(Brand name) Self-Monitoring Blood Glucose System,” (undated), the operators manual indicated, “…To Clean and Disinfect the Meter:…2…With only (name of brand name sanitizing clothes), rub the entire outside of the meter using 3 circular wiping motions with moderate pressure on the front, back, left side, right side, top and bottom of the meter…Note: Other disinfectants have not been tested. The effect of other disinfectants used interchangeably has not been tested with the meter…” During a review of the facility’s policy and procedure (P&P) titled, “Home Glucose Monitoring,” dated April 2017, the policy indicated, “Purpose – To provide guidelines for the safe use of home glucose monitoring devices. Policy – Nurses will utilize home glucose monitoring (HGM) devices, in accordance with manufacturer’s guidelines, in order to ensure the quality and accuracy of blood glucose values…All nurses utilizing HGM devices will have evidence of: 1. Specific training on the HGM device…3. Current competency…C. Testing – 1. This entire procedure will be performed in accordance with Standard precautions. 2. Blood glucose testing will be conducted in accordance with the procedure outlined by the manufacturer. 3) During an observation on November 19, 2024, at 10:52 AM, with the DPCS, the DPCS drained 30 milliliters (mls) of red colored fluid, which resembled blood, from Patient 1’s pleural catheter. The 30 mls was in a liquid state and was drained from the pleural catheter into a drainage bag connected to tubing. During a concurrent observation, and interview on November 19, 2024, at 10:58 AM, the DPCS stated she ran out of biohazard bags and did not have any with her and was going to throw away the drainage bag and 30 mls of drained fluid into the regular trash. DPCS then placed the 30 mls of fluid which was drained from Patient 1’s pleural catheter and the tubing in a thin, clear, non-labeled trash bag and stated she was going to have Patient 1’s caregiver throw it away in the regular trash because it was only 30 mls of fluid. The DPCS then stated the nurses usually bring the biohazard drainage bags/tubing to the office and the office staff brings the biohazard waste to the pharmacy. During a review of the facility’s policy and procedure (P&P) titled, “Hazardous Waste Handling,” dated April 2017, the policy indicated, “Purpose – To ensure the protection of organization personnel, patients, family/caregivers, and the community through proper handling of contaminated waste…All hazardous wastes should be discarded according to state and local regulations… During a review of the facility’s P&P titled, “Standard Precautions,” dated April 2017, the policy indicated, “Purpose – To reduce the risk of exposure to and transmission of infections when caring for patients. Policy -Organization personnel will adhere to the following precautions…Under standard precautions, blood and certain body fluids of all patients are considered potentially infectious for bloodborne pathogens, such as human immunodeficiency virus (HIV), and Hepatitis B virus (HBV)…Waste Disposal. 1. General Waste: A. Materials not contaminated or visibly soiled with blood or other infectious waste…B. General waste should be disposed of in a securely fastened plastic bag and can be placed into the patient’s trash receptacle. 2. Regulated Medical Waste: A. According to OSHA guidelines, these may include: 1. Liquid or semi-liquid blood or other potentially infectious material…4. Pathological and microbiological wastes containing blood or other potentially infectious material. B. Place regulated medical waste into a leak-proof, heavy duty, securely fastened plastic bag. Items should be double bagged…They should be disposed of according to local and/or state regulation.” During a review of the facility’s P&P titled, “Contaminated Waste Disposal,” dated April 2017, the policy indicated, “Purpose – to ensure the protection of organization personnel, patients/family/caregivers, and the community through proper handling of contaminated waste. Policy – [name of home health agency] will dispose of contaminated waste according to state and local regulations…2. Infectious wastes:…B. Blood, blood products, and body fluids: all waste blood, blood products, and body fluids greater than 20 ml. [milliliters – unit of measure] (2/3/ Oz [ounce]) in volume that exist in a free, liquid state and cannot be safely poured down a drain…blood and body fluids…1. Fluids (i.e, urine, feces, solutions, etc) should be poured down the toilet and immediately flushed…Contaminated Lab Waste…waste that cannot be disposed of by safely pouring down a drain, may be delivered to the lab after being bagged, securely closed and labeled. A. Place specimen in a leak-proof, impermeable, biohazard-labeled transport container. B. Carry the bagged specimen in the container to the lab and hand directly to lab personnel.””

“Laboratory services/CLIA waivers CFR(s): 484.100(c)(1) Laboratory services. If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient’s equipment when assisting with self-administered tests. This Standard is not met as evidenced by: Based on observation, interview, and record review, the facility failed to ensure the Clinical Laboratory Improvement Amendments waiver (CLIA waiver - allows a facility to legally perform waived tests to diagnose, treat, and assess a patient’s health, and to perform testing of blood sugar levels) was not expired. This failure resulted in the facility to not have the appropriate authorization to safely perform blood glucose testing on its patients and to be out of compliance with the CLIA regulations. Findings: During a concurrent observation, and interview on November 18, 2024, in the facility’s main lobby area, with the Director of Patient Care Services Designee (DPCSD), the facility had the CLIA waiver posted on the wall near the entrance of the facility which expired on April 24, 2023 (one year and seven months expired). The DPCSD stated the facility did not have a current CLIA waiver because the facility did not renew it. The DPCSD further stated the facility got rid of their glucometers (glucose meters used to test blood sugar levels) and instead the patients have their own glucometers. When asked if it is the facility’s nurse or the patient who performs the blood sugar test with the patients glucometer, the DPCSD stated at times, the facility staff will be the one obtaining the blood sample and conducting the blood sugar testing when training and/or education is being performed for a new diabetic patient. During an interview on November 22, 2024, at 9:20 AM, with the Assistant Administrator (ASST ADMIN), the ASST ADMIN stated the facility didn’t renew their CLIA license because the facility thought they did not need a CLIA waiver since the facility got rid of facility owned glucometers and they thought a CLIA waiver was only needed if the facility had its own glucometers regardless of who was performing the blood sugar tests (patient or facility nurse). During an observation on November 19, 2024, at 5:30 PM, a Registered Nurse 1 (RN 1) was observed to use a patient’s glucometer and a lancet to obtain a blood sample from Patient 3 and test the blood sugar level. During a review of the facility’s policy and procedure (P&P) titled, “Waived Testing,” dated April 2017, the P&P indicated, “Purpose – To define the organization’s compliance with waived testing criteria and the need for a certificate of laboratory services. Policy – The Clinical Laboratory Improvement ACT (CLIA) of 1988 requires all clinical laboratories to possess a CLIA certificate in order to perform testing on human specimens. Certain tests are examined on a waived list…When a patient performs a test on himself or herself, such as blood glucose testing on the patient’s own glucose meter, the action is not regulated by CLIA. Testing performed by one individual on another individual while carrying out professional responsibilities is an activity regulated by CLIA…2. Angels on Earth Home Health INC> will apply for and maintain a CLIA waiver on file.”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on interview, and record review, the facility failed to ensure one of three sampled patients (Patient 3) had an initial assessment (an assessment done to determine the immediate needs of a new home health patient) done within 48 hours of physician referral for home health services which occurred on September 4, 2024. This failure had the potential for Patient 3 to have unidentified and unmet care needs from the time Patient 3 was referred for home health services on September 4, 2024 to the time when the initial assessment was performed on September 13, 2024 (A total of 9 days). Findings: A review of Patient 2’s “Patient Demographics” (a document which provides medical and demographic information), undated, indicated Patient 2 had a referral date of September 4, 2024, and a start of care date of September 13, 2024, with diagnoses which included cerebral aneurysm (also known as a brain aneurysm, is a bulge or ballooning in a weakened area of an artery in the brain), hypertension (high blood pressure), and anxiety disorder (a condition that causes excessive and persistent feelings of fear, dread, and uneasiness). During a review of Patient 2’s “Comprehensive Nursing Assessment,” dated September 13, 2024, the assessment indicated, “Visit type: Initial…” This indicated the initial assessment was done 9 days after the physician referral for home health services on September 4, 2024. During a review of Patient 2’s Electronic Health Record (EHR), the EHR did not have documentation to indicate why the initial assessment was not done within 48 hours of physician referral for home health services. During an interview on November 20, 2024, at 3:03 PM, with the Director of Patient Care Services Designee (DPCSD), the DPCSD stated the facility was supposed to conduct an initial assessment of a patient within 48 hours from the time of physician referral for home health services. During an interview on November 21, 2024, at 2:31 PM, with the Office Manager (OM), the OM stated Patient 2 was had a referral date of September 4, 2024. The OM further stated the initial assessment was not done until September 13, 2024, and was not done within 48 hours but should have been. During an interview on November 21, 2024, at 2:32 PM, with the DPCSD, the DPCSD reviewed the clinical record for Patient 2 and stated the home health initial assessment was done on September 13, 2024, and was not done within 48 hours of referral for home health services. DPCSD further stated Patient 2 had no documentation in the clinical record regarding why the initial assessment was not done timely. During a concurrent interview and record review on November 21, 2024, with the DPCSD, the facility’s policy and procedure (P&P) titled, “Initial and Comprehensive Assessment” dated April 2017, was reviewed. The policy indicated, “The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of the patient’s return home, on the start of care date ordered by the physician…” the DPCSD stated the policy was not followed.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, interview, and record review, the facility failed to ensure a review of all medications (medication reconciliation) the patients were taking was conducted for three of three sampled patients (Patients 1, 2, and 3) when all 3 patients had discrepancies in the medications taken at home when compared to their plans of care (a treatment plan) and medication profile’s (a comprehensive record of all the medications that a patient is currently taking). These failures resulted in the facility and Patients 1, 2, and 3 not to have an updated “Plan of Care” (patient treatment plan), or “Medication Profile” (a comprehensive summary of all medications taken by the patient), when compared to the actual medications Patients 1, 2, and 3 were taking in the home which may contribute to medication administration errors, discrepancies, or non-compliance with physician’s orders. 1. A review of Patient 1’s “Patient Demographics” (a document which provides medical and demographic information), undated, indicated Patient 1 had a start of care date of October 8, 2024, and diagnoses which included pleural effusion (a buildup of fluid between the layers of tissue that line the lungs and chest cavity, congestive heart failure (a life-threatening condition that occurs when the heart can’t pump enough blood throughout the body), and diabetes mellitus (a condition In which the body cant regulate blood sugars well and causes elevated blood sugar levels). During a concurrent observation, and record review on November 19, 2024, at 11:05 AM, at Patient 1’s home with the Director of Patient Care Services (DPCS), and in the presence of Patient 1, an observation of Patient 1’s medication bottles (she was actively taking) were compared Patient 1’s most current “Medication Profile,” dated with an episode period of October 8, 2024 through December 6, 2024, and “Home Health Certification and Plan of Care,” dated with a certification period of October 8, 2024 through December 6, 2024. The following discrepancies were noted: 1a. Patient 1’s home medications (she was actively taking) included Furosemide (a diuretic medication used to treat edema [swelling]) 20 milligram (mg – unit of measure) tablet by mouth, twice daily. Patient 1’s “Medication Profile,” and “Home Health Certification and Plan of Care,” indicated Patient 1’s was taking Furosemide 20 mg only once a day (discrepancy in frequency). 1b. Patient 1’s “Medication Profile,” and “Home Health Certification and Plan of Care,” indicated Patient 1 was taking Bisacodyl (medication used to treat constipation) 10 mg rectal suppository, daily as needed, Lactulose (medication used to treat constipation) 20 gram/30 ml (20 grams per 30 mls) orally (by mouth) every six hours as needed, docusate sodium (medication used to treat constipation) 100 mg capsule twice daily, and levofloxacin (an antibiotic medication) 500 mg tablet by mouth, once daily at bedtime. However, none of these medications were in Patient 1’s home medications supply and Patient 1 was only taking these medications while in the hospital. 1c. Patient 1’s home medications (she was actively taking) included Melatonin (medication used to improve sleep) 5 mg tablets. Patient 1’s “Medication Profile,” and “Home Health Certification and Plan of Care,” indicated the patient was taking Melatonin 3 mg tablet by mouth, every 6 hours as needed (discrepancy in dose). 1d. Patient 1’s home medications included Metoprolol Tartrate (medication commonly used to treat high blood pressure or chest pain) 50 mg tablet by mouth, one tablet twice daily. Patient 1’s “Medication Profile,” and “Home Health Certification and Plan of Care,” indicated Patient 1 was taking Metoprolol Succinate ER (extended release) 25 mg tablet daily (discrepancy in medication type and dose). During a concurrent interview, and record review on November 19, 2024, at 11:05 AM, with the DPCS, the DPCS stated medications were supposed to be checked by the nurse every visit and the medication profile was supposed to be updated, but it was not being done for Patient 1. 2. A review of Patient 2’s “Patient Demographics” (a document which provides medical and demographic information), undated, indicated Patient 2 had a start of care date of September 13, 2024, and diagnoses which included cerebral aneurysm (also known as a brain aneurysm, is a bulge or ballooning in a weakened area of an artery in the brain), hypertension (high blood pressure), and anxiety disorder (a condition that causes excessive and persistent feelings of fear, dread, and uneasiness). During a concurrent observation, and record review on November 19, 2024, at 3:18 PM, at Patient 2’s home with Registered Nurse 1 (RN 1), and in the presence of Patient 2, an observation of Patient 2’s medication bottles (she was actively taking) were compared with Patient 2’s most current “Medication Profile,” dated with an episode period of November 12, 2024 through January 10, 2025, and “Home Health Certification and Plan of Care,” dated with a certification period of September 13, 2024, through November 11, 2024. The following discrepancies were noted: 2a. Patient 2’s home medications (she was actively taking) included Docusate Sodium (medication used to treat constipation) 50 milligrams (mg – unit of measure) soft gel by mouth, once daily. Patient 2’s “Medication Profile,” and “Home Health Certification and Plan of Care,” indicated Patient 2 was taking Docusate Sodium 100 mg capsule, twice daily (discrepancy frequency and total dose). 2b. Patient 2’s home medications (she was actively taking) included amlodipine (medication used to treat high blood pressure) 5 mg, twice daily. Patient 2’s “Medication Profile,” and “Home Health Certification and Plan of Care,” indicated Patient 2 was taking amolodipine 10 mg – atorvastatin 10 mg (a combination medication used to treat high blood pressure and high cholesterol) (discrepancy in medication type). 2c. Patient 2’s home medications (she was actively taking) included the following medications: calcitriol 0.25 microgram (mcg – unit of measure) capsule, 1 capsule daily; cinacalcet (medication used to treat hyperparathyroidism [overactive functioning of the parathyroid glands] in people who are on long-term dialysis for kidney disease) 30 mg tablet, 2 tablets daily; ondansetron hcl (medication used to treat nausea and vomiting) 4 mg tablet, 1 tablet by mouth every 8 hours as needed (for vomiting); Vitamin D2 1.25 mg 50,000 units, one capsule, once a week; Ciprofloxacin hcl (an antibiotic) 750 mg tablet by mouth, once daily for three days when instructed by peritoneal dialysis nurse or after hours nurse; Rena vite tablet (multivitamin used commonly by dialysis patients) , one tablet a day; acetaminophen (pain reliever) 500 mg tablet, one tablet once a day; simvastatin (medication used to treat high cholesterol) 20 mg tablet, once a day; tramadol hcl (strong pain reliever) 50 mg tablet, 1 tablet two times daily; famotidine (antacid medication) 20 mg tablet, 1 tablet twice daily; atenolol (medication used to treat high blood pressure or chest pain) 25 mg tablet, 1 tablet once a day; albuterol sulfate (medication used to treat difficulty breathing, wheezing, or shortness of breath) 90 mcg per actuation, as needed. None of these medications were indicated on Patient 2’s “Medication Profile,” or “Home Health Certification and Plan of Care.” During an interview on November 19, 2024, at 3:35 PM, with RN 1, RN 1 stated there were a lot of medication discrepancies between Patient 2’s “Medication Profile,” and “Home Health Certification and Plan of Care,” when compared to the medications Patient 2 was taking at home. During an interview on November 19, 2024, at 3:40 PM, with Patient 2’s caregiver (CG 2), CG 2 stated Patient 2’s most recent medication changes were done on September 6, 2024 (prior to the current certification period). 3. A review of Patient 3’s “Patient Demographics” (a document which provides medical and demographic information), undated, indicated Patient 3 had a start of care date of September 9, 2024, and diagnoses which included acute respiratory failure (a medical condition that occurs when the body’s respiratory system can’t provide enough oxygen to the blood or remove enough carbon dioxide from the body) and diabetes mellitus (a condition In which the body can’t regulate blood sugars well and causes elevated blood sugar levels). During a concurrent observation, and interview on November 19, 2024, at 5:20 PM, at Patient 3’s location of residence with Registered Nurse 1 (RN 1), and in the presence of Patient 3 and Patient 3’s caregiver (CG 3), RN 1 stated he was performing a medication reconciliation of Patient 3’s meds. RN 1 was comparing the medications listed on Patient 3’s “Medication Profile,” dated November 8, 2024 through January 6, 2025, against medications listed on Patient 3’s Medication Administration Record (MAR – a document used by staff to record the administration of medications) from the facility at which Patient 3 resided, dated November 1, 2024. The following discrepancies were noted: 3a. Patient 3’s “Medication Profile,” indicated Patient 3 was taking atorvastatin (medication used to treat high cholesterol) 10 mg tablet at bedtime daily; colace (stool softener) 100 mg capsule, 1 capsule twice daily; Tylenol arthritis pain (pain reliever) 650 mg tablet every six hours as needed; senekot (laxative used to treat constipation) 8.6 mg tablet at night; protonix (medication that treats conditions that cause too much stomach acid, like heartburn, stomach ulcers and reflux disease) 40 mg 1 tablet by mouth, daily; and ibuprofen (medication used to treat pain and inflammation) 400 mg tablet every 8 hours as needed for pain. However, none of these medications were on Patient 3’s MAR at the facility as having been administered to the patient 3b. Patient 3’s “Medication Profile,” indicated Patient 3 was taking metformin (medication used to help lower blood sugar levels) 100 mg 1 tablet twice daily but the MAR (from the facility in which the patient resided) indicated Patient 3 was taking metformin hcl 1,000 mg tablet twice daily (discrepancy in dose). 3c. Patient 3’s MAR (from the facility in which the patient resided) indicated Patient 3 was being administered lubricating eyedrops [brand name] 1 drop into both eyes daily. When compared to Patient 3’s “Medication Profile,” this medication was not listed. During an interview on November 19, 2024, at 5:22 PM, with Patient 3’s caregiver (CG 3), CG 3 stated Patient 3 has been on his current medications since September 4, 2024, and there has not been any changes to medications since then. During an interview on November 19, 2024, at 6:18 PM, with RN 1, when asked if RN 1 ever looks at the patients physical medication bottles or containers during medication reconciliation, RN 1 stated he usually only reconciles medications off the paperwork and doesn’t look at the medication bottles themselves unless they (medications) are available near him during his medication review. RN 1 further stated he doesn’t specifically ask to see the medications themselves. During an interview on November 21, 2024, at 10:39 AM, with the Director of Patient Care Services (DPCS), the DPCS stated upon each home visit, nurses were supposed to ask the patients and/or caregivers if there were changes to medications and the nurses were also supposed to check the actual medications the patients were taking to observe if there were changes to the medication prescriptions, to identify if there were new medications, and to determine if the patient was taking the medications as expected or if refills were needed for any medications. During a concurrent interview, and record review on November 21, 2024, at 10:56 AM, with the DPCS, the facility’s policy and procedure (P&P) titled, “Medication Profile,” dated April 2017, was reviewed. The policy indicated, “Purpose – To define the use of the medication profile in evaluating a patient’s medication regimen. Policy – Patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications…” The DPCS stated patients medications profiles were supposed to be accurate and complete and include all medications the patients were taking. The DPCS stated the facility did not follow the P&P. During a review of the facility’s P&P titled, “Contents of the Clinical Record,” dated April 2017, the policy indicated, “…1. The following information will be available in the clinical record, as applicable to care and services provided:…DD. Current medication profile, including prescription and nonprescription medications, herbal products and home remedies, dose, frequency, route of administration, and new, changed, or discontinued medications…””

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on observation, interview, and record review, the facility failed to ensure a Registered Nurse 1 (RN 1) administered treatments and services only as prescribed by a physician when RN 1 tested the blood glucose (level of sugar in the blood) for one of three sampled patients (Patient 3) without a physician’s order. This failure resulted in RN 1 to perform an invasive blood sugar fingerstick procedure (a procedure using a lancet to draw a drop or two of blood from a finger to test blood sugar levels) on Patient 3 without having the appropriate authorizing orders to do so. Findings: During a review of Patient 3’s “Patient Demographics” (a document which provides medical and demographic information), undated, indicated Patient 3 had a start of care date of September 9, 2024, and diagnoses which included acute respiratory failure (a medical condition that occurs when the body’s respiratory system can’t provide enough oxygen to the blood or remove enough carbon dioxide from the body) and diabetes mellitus (a condition In which the body can’t regulate blood sugars well and causes elevated blood sugar levels). During an interview on November 19, 2024, at 5:15 PM, with RN 1, the RN 1 asked Patient 3 and Patient 3’s Caregiver (CG 3) if the patient checks his blood sugar. CG 3 stated the patient was not checking his blood sugar but they had an upcoming doctors appointment and were going to get instructions on what interventions they were supposed to do at that time (to manage Patient 3’s diabetes mellitus). During a concurrent observation, and interview on November 19, 2024, at 5:30 PM, with RN 1, the RN 1 asked Patient 3 and CG 3, if Patient 3 had a glucometer (a device used to test blood sugar levels). CG 3 stated Patient 3 did not have a glucometer, but the facility had a glucometer which belonged to another patient. The RN 1 stated, “Ok I’ll just clean it first.” CG 3 then gave the RN 1 a glucometer in a zipper pouch which had the name of another patient on it. The RN 1 removed the glucometer from the zipper pouch and cleaned it (the glucometer) with an alcohol wipe. The RN 1 then proceeded to use the glucometer to test Patient 3’s blood sugar level. During an interview on November 19, 2024, at 5:43 PM, with RN 1, the RN 1 stated the glucometer used on Patient 3 belonged to another patient in the facility. The RN 1 further stated he did not know if the glucometer was able to be used on multiple patients or if it was intended to only be used by the patient it was assigned to. During a subsequent interview on November 19, 2024, at 5:45 PM, with RN 1, the RN 1 stated Patient 3 did not have any physician’s orders to check blood sugar levels and stated he just wanted to check it (blood sugar) to see if it was elevated. During an interview on November 22, 2024, at 8:45 AM, with the Director of Patient Care Services (DPCS), the DPCS stated registered nurses were not supposed to perform blood sugar testing on a patient without a physician’s order. During a review of Patient 3’s “Home Health Certification and Plan of Care,” with a certification period of November 8, 2024, to January 6, 2025, the plan of care did not include a physicians order for skilled nursing to check Patient 3’s blood sugar level. During a review of the facility’s policy and procedure (P&P) titled, “Home Glucose Monitoring,” dated April 2017, the P&P indicated, “Purpose – To provide guidelines for the safe use of home glucose monitoring devices…B. Before the test:…2. Verify orders as needed…””

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on observation, interview, and record review, the facility failed to ensure a Registered Nurse 1 (RN 1) followed up with a physician regarding Patient 3’s elevated blood sugar level which RN 1 stated was “dangerously high”. Instead, RN 1 instructed Patient 3’s Caregiver (CG 3) to follow up with a physician as soon as possible. This failure resulted in RN 1 to rely on Patient 3’s caregiver to consult with a physician regarding Patient 3’s elevated blood sugar level which RN 1 stated was dangerously high. This had the potential for a delay in Patient 3 to receive treatment and services by a physician if needed. Findings: A review of Patient 3’s “Patient Demographics” (a document which provides medical and demographic information), undated, indicated Patient 3 had a start of care date of September 9, 2024, and diagnoses which included acute respiratory failure (a medical condition that occurs when the body’s respiratory system can’t provide enough oxygen to the blood or remove enough carbon dioxide from the body) and diabetes mellitus (a condition In which the body can’t regulate blood sugars well and causes elevated blood sugar levels). During a concurrent observation, and interview on November 19, 2024, at 5:30 PM, RN 1 checked Patient 3’s blood sugar level and it was 326 milligrams per deciliter (mg/dl – unit of measure). RN 1 then told CG 3 to not provide Patient 3 with a big breakfast the next day and to inform a physician as soon as possible regarding Patient 3’s blood sugar level of 326 mg/dl. RN 1 further stated the blood sugar level of 326 was “dangerously high.” CG 3 stated he was unable to contact a doctor that night and would have to do it tomorrow. RN 3 then stated he (CG 3) should call the doctor first thing in the morning and again stated the blood sugar was “dangerously high.” During an interview on November 19, 2024, at 5:45 PM, with RN 1, the RN 1 stated Patient 3 did not have any physician’s orders to check blood sugar levels and stated he just wanted to check it (blood sugar) to see if it was elevated. RN 1 did not attempt to contact a physician directly or inform the Director of Patient Care Services or Clinical Coordinator for follow up with a physician. Not until asked by the surveyor if there was anything else RN 1 was going to do regarding the “dangerously high” blood sugar level, did he (RN 1) decide he was also going to contact his supervisor for guidance on what to do. During a review of the facility’s policy and procedure titled, “Care Coordination,” Dated April 2017, the policy indicated, “…Timely and ongoing communication is the responsibility of each team member, will be appropriate to the needs and abilities of the patient, and will be relevant to the care provided. The clinicians will be responsible for facilitiating communications about changes in the patient’s status…” During a review of the facility’s policy and procedure titled, “Monitoring Patient’s Response/Reporting to Physician,” dated April 2017, the policy indicated, “Purpose – To provide guidelines for monitoring the patient’s conditions, response to care and for reporting to the patient’s physician. Policy – 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…3. The patient’s physician will be contacted on the same day when any of the following occur: A. Changes in the patient’s condition… H. When results are received for relevant laboratory tests ordered. All critical test results will be phoned to the physician within an agency designated time frame and will be read back and confirmed…5. When unable to contact the patient’s physician for medical consultation warranted by a change in patient’s condition, the following procedures will be followed: A. The nurses or therapist will immediately notify the Clinical Supervisor or designee regarding the need for medical consultation and problems encountered. B. An attempt will be made by the Clinical Supervisor or designee to contact the patient’s physician. C. If the Clinical Supervisor or designee is unable to contact the patient’s physician, the Clinical Supervisor or designee will notify the organization’s Medical Director of the change in patient condition and the inability to contact the patient’s physician to request medical consultation..””