Every finding on record at Asap Home Health Service, Inc

The following reflects the findings of the California Department of Public Health during a Recertification Survey. Representing the Department of Public Health: Surveyor ID # 43979 -RN - HFEN Surveyor ID # 43929 -RN – HFEN Unduplicated admissions: 10 Sample Size: 7 Home Visits: 3 Closed Record review: 2

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to review and update their emergency preparedness plan at least every two years for seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7). The deficient practice has the potential to affect the safety of the patients and put them at risk of danger during an emergency or disaster. A record review of Patient 1 medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 2/2/2010 with diagnosis including autistic disorder (a neurological and developmental disorder that affects interactions with others, communication, learning, and behavior). A review of Patient 2's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 12/3/2014 with diagnosis including cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). A review of Patient 3's medical record form titled “Home Health Certification and Plan of Care” dated 11/28/2023 – 1/26/2024, indicated start of care date 12/8/2021 with diagnosis including congenital tracheomalacia (weakness of the walls of the windpipe). A review of Patient 4’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/4/2023 -2/1/2023, indicated a start of care date on 5/9/207, with a primary diagnosis of epilepsy (seizures). A review of Patient 5’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 11/25/2023-1/23/2024, indicated a start of care date on 5/29/2023, with a primary diagnosis of cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). A review of Patient 6’s medical record titled, “OASIS-E Transfer Discharge”, dated 11/30/2023, indicated a start of care date on 11/15/2023, with diagnosis including cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). A review of Patient 7’s medical record titled, “OASIS-E Transfer Discharge”, dated 8/22/2023, indicated a start of care date on 7/23/2023, with diagnosis including chronic respiratory failure (difficulty breathing). During a record review of HHA’s “Emergency Preparedness Program” binder, form titled “Acknowledgement of Emergency Operation Program Review” dated 4/5/2023, indicated sections “Reviewed and Approved: Administrator, on behalf of the Agency” were left blank. During a concurrent interview and record review on 1/25/2024, at 12 p.m., with the Administrator (ADM), ADM of HHA’s Emergency Preparedness Plan binder, ADM stated form “Acknowledgement of Emergency Operation Program Review” dated 4/5/2023, was not signed. ADM stated he will notify the person in charge. During a concurrent interview and record review on 1/26/2024, at 12 p.m. with the Business Manager (BM) of HHA’s Emergency Preparedness Plan binder, BM stated the binder was reviewed by herself and ADM, but both forgot to sign. BM stated their signatures would indicate the plan of action was approved with the most recent information. A review of the agency's undated policy and procedure titled, "Emergency Management Plan” revised 4/2021 indicated “The Emergency Preparedness Program, Emergency Plan and Policies and Procedures will be reviewed and updated at least every 2 years, or more frequently if needed.” A review of HHA’s policy and procedure titled “Emergency Management Plan” revised 4/2021, indicated “The Emergency Preparedness Program, emergency Plan and Policies and Procedures will be reviewed and updated at least every 2 years, or more frequently if needed.”

The following reflects the findings of the California Department of Public Health during a Recertification Survey. Representing the Department of Public Health: Surveyor ID # 43979 -RN - HFEN Surveyor ID # 43929 -RN – HFEN Unduplicated admissions: 10 Sample Size: 7 Home Visits: 3 Closed Record review: 2

State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to ensure seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7) received information regarding the State toll free home health telephone hotline, its contact information, its hours of operation, and its purpose. This failure resulted in a violation of patient’s rights due to not having the information necessary to make a complaint regarding the agency’s care. A record review of Patient 1's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 2/2/2010 with diagnosis including autistic disorder (a neurological and developmental disorder that affects interactions with others, communication, learning, and behavior). A review of Patient 2's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 12/3/2014 with diagnosis including cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). A review of Patient 3's medical record form titled “Home Health Certification and Plan of Care” dated 11/28/2023 – 1/26/2024, indicated start of care date 12/8/2021 with diagnosis including congenital tracheomalacia (weakness of the walls of the windpipe). A review of Patient 4’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/4/2023 -2/1/2023, indicated a start of care date on 5/9/207, with a primary diagnosis of epilepsy (seizures). A review of Patient 5’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 11/25/2023-1/23/2024, indicated a start of care date on 5/29/2023, with a primary diagnosis of cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). A review of Patient 6’s medical record titled, “OASIS-E Transfer Discharge”, dated 11/30/2023, indicated a start of care date on 11/15/2023, with diagnoses including cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). A review of Patient 7’s medical record titled, “OASIS-E Transfer Discharge”, dated 8/22/2023, indicated a start of care date on 7/23/2023, with diagnoses including chronic respiratory failure (difficulty breathing). A review of HHA’s patient admission folder indicated the State home health contact information, hours of operation, and purpose were not included in their forms. A review of HHA’s form titled “Patient Rights and Responsibilities” undated, indicated the State home health contact information, hours of operation, and purpose were not included in their forms. During a concurrent interview and record review on 1/25/2024, at 9:40 a.m., with Registered Nurse 1 (RN1) of patients’ admission folder, RN1 stated he was unable to locate the State complaint hotline number or contact information in the documents inside the folder. During a concurrent interview and record review on 1/25/2024 at 9:50 a.m., with the Administrator (ADM) of patients’ admission folder, ADM stated the State complaint information was not included in the patient’s packet. ADM stated it should be included because it's part of their right to have that information in case they need to 4er354call and make a complaint. A review of HHA’s policy and procedure titled “Patient Bill of Rights” undated, indicated “The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care of their rights. The Patient Bill of Rights statement defines the right of the patient to: Receive in writing, prior to the start of care, the telephone numbers for the State Home Health Hotline and the Administration number, including hours of operation, and the purpose of the hotlines to receive complaints or questions about the organization.

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7) received information on Federal and State funded entities available in the areas they reside in. This failure had the potential to prevent patients to be familiar with the services that are available to them. A record review of Patient 1's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 2/2/2010 with diagnoses including autistic disorder (a neurological and developmental disorder that affects interactions with others, communication, learning, and behavior). A review of Patient 2's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 12/3/2014 with diagnoses including cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). A review of Patient 3's medical record form titled “Home Health Certification and Plan of Care” dated 11/28/2023 – 1/26/2024, indicated start of care date 12/8/2021 with diagnoses including congenital tracheomalacia (weakness of the walls of the windpipe). A review of Patient 4’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/4/2023 -2/1/2023, indicated a start of care date on 5/9/207, with a primary diagnosis of epilepsy (seizures). A review of Patient 5’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 11/25/2023-1/23/2024, indicated a start of care date on 5/29/2023, with a primary diagnosis of cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). A review of Patient 6’s medical record titled, “OASIS-E Transfer Discharge”, dated 11/30/2023, indicated a start of care date on 11/15/2023, with diagnoses including cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). A review of Patient 7’s medical record titled, “OASIS-E Transfer Discharge”, dated 8/22/2023, indicated a start of care date on 7/23/2023, with diagnoses including chronic respiratory failure (difficulty breathing). A review of HHA’s patient admission folder indicated the State and Federally funded entities contact information were not included in their forms. During a concurrent interview and record review on 1/25/2024 at 9:53 a.m., with the Administrator (ADM) of patients’ admission folder, ADM stated the folder did not contain the State and Federally funded entity contact information. ADM stated the HHA needed to provide patients with the information, so they can be informed of the available resources. A review of HHA’s policy and procedure titled “Patient Bill of Rights” undated, indicated “The patient will be informed verbally and in writing during the initial evaluation visit, in advance of furnishing care of their rights. The Patient Bill of Rights statement defines the right of the patient to: The names, addresses and telephone numbers of the following Federally funded and State-funded entities that serve the area where the patient resides: Agency of aging; center for independent living; Aging and disability resource center; Quality improvements organizations.”

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 Home Health Agency (HHA) failed to review and document all the current medications and treatments for two of seven sampled patients (Patient 2 and Patient 4) were currently using. This deficient practice placed the patients at risk of drug-to-drug interaction and harm by not knowing which medications the patients were taking. 1. A review of Patient 2's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 12/3/2014 with diagnoses including cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). A review of Patient 2's medical record form titled “Physician Order” dated 3/16/2023, indicated “Neomycin-Polymyxin B- Dexamethasone” one drop into each eye two times daily. A review of Patient 2's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated “Neomycin-Polymyxin B- Dexamethasone” one drop into each eye two times daily. A review of Patient 2's medical record form provided on 1/23/2024, titled “Medication Profile” dated 10/17/2023 to 12/15/2023, indicated Patient 2 was ordered “Neomycin-Polymyxin B- Dexamethasone” one drop into each eye two times daily. During a joint home visit on 1/24/2024, at 10 a.m., with Registered Nurse 1 (RN1) and Certified Home Health Aide/Care Giver 1 (CHHA/CG1) at Patient 2’s home, RN1 reviewed Patient 2’s home medication. Patient 2’s medication bottle of Neomycin-Polymyxin B- Dexamethasone eye drop label read the following: one drop into each eye three times daily. Label also indicated prescription was filled on 7/5/2023. CHHA/CG1 stated she instills Patient 2’s eye drops as needed. The HHA failed to ensure Patient 2’s medication profile was updated to reflect the current eye drop medication frequency. 2. A review of Patient 4’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/4/2023 -2/1/2023, indicated a start of care date on 5/9/207, with a primary diagnosis of epilepsy (seizures). During the home visit on 1/24/2024, at 8:45 a.m., Licensed Vocational Nurse 2 (LVN 2) reviewed Patient 4’s home medications using record titled, “Medication Profile”, dated 12/22/2023. The following medications were not updated in Patient 4’s Medication Profile: -Clobazam (to prevent convulsions-involuntary body movements caused by the brain) 20 mg (mg-milligram, unit of measurement) take ½ (half) tablet by mouth every morning and 1 tablet every evening. The medication profile indicated a 10 mg tablet to be taken twice a day. LVN 2 stated the medication profile did not indicate the dosage and instructions according to the label. The label and the medication profile did not match. LVN 2 stated it was important for the instructions on the label match the medication profile so there are no medication errors. LVN 2 stated it was the responsibility of the Registered Nurse (RN) to update the medication profile. LVN 2 stated, “I just report if there is a change”. -Risperidone (to threat psychotic (mental disorder) episodes). There were two bottles of the medication. One bottle had a label to take 0.5 mg tablet by mouth every morning. The second bottles were to take 1 mg by mouth every evening. LVN 2 stated the medication profile did not indicate the 0.5 mg dose and the instructions on how to take the medication were not correct in the medication profile. -Vitamin D3 (a supplement) 125 mcg (mcg-micrograms). LVN 2 stated the vitamin was not listed in the medication profile. Vitamin D as listed, Patient 4 was no longer taking. The HHA failed to ensure Patient 4’s medication profile accurately reflected the medications he was taking. During an interview on 1/24/2024 at 12:50 p.m., with Registered Nurse 1 (RN1), RN1 stated patients’ medication should be reconciliated every skilled nurse visit to make sure there were no changes their medications or patient condition. RN1 stated if medication reconciliation was not done, “We might not be aware of any changes with patients”. A review of HHA’s policy and procedure titled “Administering Medication & Profile” undated, indicated “The RN (Registered Nurse) will be responsible for monitoring the patient’s medication regimen through a collaborative effort with the multi-disciplinary team and physician involved in the patients care. An accurate and current list of all prescription and over the counted medication taken by the patient will be maintained on the medication profile. Changes in the medication n regimen will be documented in the clinical record…”

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure two of seven sample patients' (Patient 1 and Patient 4) plans of care (an individualized care planned) were updated to reflect their current medications. This failure had the potential to result in confusion to staff and caregivers, placing the patients at risk of a drug-to-drug interaction and harm by not knowing which medications the patients were taking. 1. A review of Patient 1's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 2/2/2010 with diagnosis including autistic disorder (a neurological and developmental disorder that affects interactions with others, communication, learning, and behavior). During a concurrent interview and record review on 1/25/2024, at 12:30 p.m., with Registered Nurse 1 (RN1) of Patient 1’s medical record form titled “Physician Order” dated 11/5/2023, indicated “New Medication – Quetiapine” and “Discontinued – Gabapentin”. RN1 stated the order was received on 11/5/2023 and he reviewed Patient 1’s POC on 11/16/2023. RN1 stated when there are changes to a patients POC, the HHA updates the POC, prints out a new one, and shreds the old POC. During a concurrent interview and record review on 1/25/2024 at 12:30 p.m., with Registered Nurse 1 (RN1) of Patient 1's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, form indicated Gabapentin (seizure Medication), RN1 stated Gabapentin was discontinued and it should not be documented on Patient 1’s POC. RN1 stated there was a doctor’s order to give Patient 1 Quetiapine (medication for depression), but it was not documented on Patient 1’s POC. 2. A review of Patient 4’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/4/2023 -2/1/2023, indicated a start of care date on 5/9/207, with a primary diagnosis of epilepsy (seizures). During a concurrent interview and record review on 1/25/2024, at 10:43 a.m., RN 1 reviewed Patient 4’s record titled, “Home Health Certification and Plan of Care” (POC), for certification period 12/4/2023 -2/1/2023. RN 1 stated he was the one who reviewed the POC to make sure there were no medication errors and to make sure everything provided was accurate. RN 1 stated he reviewed the POC for accuracy on 11/6/2023. During an observation during the home visit on 1/24/2024, at 8:45 a.m., Licensed Vocational Nurse 2 (LVN 2) reviewed Patient 4’s home medications. The medication Clobazam (to prevent convulsions-involuntary body movements caused by the brain) 20 mg (mg-milligram, unit of measurement) label indicated to take ½ (half) tablet by mouth every morning and 1 tablet every evening. There were two bottles of medication Risperidone (to threat psychotic (mental disorder) episodes). One bottle had a label to take 0.5 mg tablet by mouth every morning. The second medication bottle label indicated to take 1 mg by mouth every evening. Medication Vitamin D3 (a supplement) 125 mcg (mcg-micrograms) was also at the home. A review of Patient 4’s record titled, “Home Health Certification and Plan of Care” (POC), for certification period 12/4/2023 -2/1/2023, did not accurately list the medications Patient 4 was taking at home. The HHA failed to ensure the plan of care was updated to accurately reflect the medications Patient 4 was taking at home. A review of HHA’s policy and procedure titled “Plan of Treatment” undated, indicated “A home health agency has established policies and procedures for assuring that services and times to be provided are specified under a plan of treatment established and regularly reviewed by the physician responsible for the care of each patient and singed within 20 days. The health professional is expected to bring to the attention of the physician, those changes in the patient’s condition which indicate the need for altering the treatment plan or for termination services.”

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure a Registered Nurse updated the comprehensive assessment for the recertification period for five of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, and Patient 5). This deficient practice had the potential to result in the inability to identify the decline or progress of the patient's health status to promptly implement further intervention and treatment in coordination the physician. 1. A record review of Patient 1's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 2/2/2010 with diagnosis including autistic disorder (a neurological and developmental disorder that affects interactions with others, communication, learning, and behavior). A review of Patient 1’s medical record form titled “OASIS- E Recertification” dated 12/7/2023, indicated Patient 1 had a recertification assessment on 12/7/2023. During an interview on 1/25/2024 at 12:30 p.m., with Registered Nurse 1 (RN1), RN1 stated Patient 1’s last recertification assessment was conducted on 12/7/2023, and Patient 1’s current recertification period began on 12/16/2023. RN1 stated Patient 1’s recertification assessment was conducted nine days before his recertification period to be able to generate Patient 1’s plan of care. The HHA failed to ensure Patient 1’s recertification assessment was performed five days prior the ending of his last recertification period. 2. A review of Patient 2's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 12/3/2014 with diagnosis including cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). A review of Patient 2’s medical record form titled “OASIS- E Recertification” dated 12/7/2023, indicated Patient 2 had a recertification assessment on 12/7/2023. During an interview on 1/25/2024 at 1:40 p.m., with RN1, RN1 stated Patient 2’s last recertification assessment was conducted on 12/7/2023, and Patient 2’s current recertification period began on 12/16/2023. RN1 stated Patient 2’s recertification assessment was conducted nine days before her recertification period to be able to generate Patient 2’s plan of care. The HHA failed to ensure Patient 2’s recertification assessment was performed five days prior the ending of her last recertification period. 3. A review of Patient 3's medical record form titled “Home Health Certification and Plan of Care” dated 11/28/2023 – 1/26/2024, indicated start of care date 12/8/2021 with diagnosis including congenital tracheomalacia (weakness of the walls of the windpipe). A review of Patient 3’s medical record form titled “OASIS- E Recertification” dated 11/4/2023, indicated Patient 3 had a recertification assessment on 11/4/2023. During an interview on 1/25/2024 at 12:20 p.m., with RN1, RN1 stated Patient 3’s last recertification assessment was conducted on 11/4/2023, and Patient 3’s current recertification period began on 11/28/2023. RN1 stated Patient 3’s recertification assessment was conducted 24 days before her recertification period to be able to generate Patient 3’s plan of care. The HHA failed to ensure Patient 3’s recertification assessment was performed five days prior the ending of her last recertification period. 4. A review of Patient 4’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/4/2023 -2/1/2023, indicated a start of care date on 5/9/207, with a primary diagnosis of epilepsy (seizures). During a concurrent interview and record review on 1/25/2024, at 10:48 a.m., RN 1 reviewed Patient 4’s record titled, “OASIS-E Recertification”, dated 11/14/2023. RN 1 stated this was the recertification assessment for the next home health period to start on 12/4/2023. RN 1 stated the assessment was done ahead of time because it was needed to make the plan of care, that way the doctor can review and sign the plan of care. The HHA failed to ensure Patient 4’s recertification assessment was performed five days prior the ending of her last recertification period. 5. A review of Patient 5’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 11/25/2023-1/23/2024, indicated a start of care date on 5/29/2023, with a primary diagnosis of cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). During a concurrent interview and record review on 1/25/2024, at 11:15 a.m., RN 1 reviewed Patient 5’s record titled, “OASIS-E Recertification”, dated 11/15/2023. RN 1 stated this was the recertification assessment for the next home health period to start on 11/25/2023. RN 1 stated the assessment was done ahead of time because it was needed to make the plan of care, that way the doctor can review and sign the plan of care. The HHA failed to ensure Patient 5’s recertification assessment was performed five days prior the ending of her last recertification period. A review of HHA’s policy and procedure titled “Reassessment/Recertification” undated, indicated “For each new episode of care Medicare adults, a comprehensive assessment will be completed no earlier that five (5) days before and no later than one (1) day before the calendar day on which the new episode of care will begin for Medicare adults. For each new episode of care, Non-Medicare or Pediatrics, a comprehensive assessment will be completed within 30 days before and no later that 1 (one) day before the calendar day on which the new episode of care will begin.”

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 and interview the Registered Nurse Supervisor (RN1) failed to change gloves while providing care to two of seven sample patients (Patient 1 and Patient 2). This failure had the potential to result in placing patients at risk of contracting and/or transmitting diseases to other patients. A review of Patient 1's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 2/2/2010 with diagnosis including autistic disorder (a neurological and developmental disorder that affects interactions with others, communication, learning, and behavior). A review of Patient 2's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 12/3/2014 with diagnosis including cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). During a joint home visit on 1/24/2024 at 12 p.m., with RN1 to Patient 1's and Patient 2’s home, RN1 noted using hand sanitizer prior to providing care to Patient 1. RN1 noted started providing care to Patient 2 without removing the gloves he was wearing while providing care to Patient 2. RN1 noted taking off and using hand sanitizer after providing care to both Patient 1 and Patient 2. During an interview on 1/25/2024 at 9:30 a.m., with RN1, RN1 stated he should have changed the gloves he was wearing when providing care to different patients. RN1 stated, “I am assuming since you’re asking, that I should have.” RN1 stated he should have changed gloves between patients to prevent transmitting a disease that could be occurring. A review of HHA’s policy and procedure titled “Infection Control for Nursing Services” undated, indicated “Proper hand washing technique will be done before and after patient contact.” A review of HHA’s policy and procedure titled “Hand Washing Technique” undated, indicated “Hands must be washed before and after of patient contact with an antimicrobial soap.”

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review the Home Health Agency (HHA) failed to ensure two of seven sample patients (Patient 1 and Patient 2) received treatments and/or services in accordance with their written plans of care by not monitoring Patient 1‘s weight and not reassessing Patients 2's blood pressure (BP). This failure had the potential to result in placing the patients at risk of unintentional weight loss or gain and out of control BP results. 1. A review of Patient 1's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 2/2/2010 with diagnosis including autistic disorder (a neurological and developmental disorder that affects interactions with others, communication, learning, and behavior). A review of Patient 1’s medical record form titled “HHA Care Plan” dated 12/7/2023, indicated “Weight – Every Week”. A review of Patient 1's medical record form titled “Hours Worked: Horas Trabajadas:” dated 1/14/2024 to 1/20/2024, indicated section “LBS/Pounds/Libras” were left blank for dated 1/14/2024 to 1/20/2024. During a concurrent interview and record review on 1/25/2024 at 1 p.m., with Registered Nurse 1 (RN1) of Patient 1’s medical record form titled “HHA Care Plan” dated 12/7/2023, RN1 stated the form indicated the CHHA’s (Certified Home Health Aide) home plan for the patient. RN1 stated Patient 1’s HHA Care Plan stated he should be weighed weekly. The HHA failed to ensure Patient 1’s weight was monitored on a weekly basis as ordered. 2. A review of Patient 2's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 12/3/2014 with diagnosis including cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). It also indicated “Notify MD of diastolic BP greater that (>) 90… - If vital signs are out of the patients’ normal range, please try the following interventions and re-take. Vital signs: reposition the patient, check the equipment to endure its functionality, rotate the site, and redo the procedure.” During a joint home visit on 1/24/2024 at 12:30 p.m., with RN1 at Patient 2’s home, RN1 measured Patient 2’s blood pressure result of 122/103. RN1 continued to assess Patient 2 but was not observed reassessing Patient 2’s high diastolic (heart disease and stroke risk) pressure. During a concurrent interview and record review on 1/25/2024 at 9:30 a.m., with RN1 of Patient 2’s medical record, RN1 stated he forgot to check Patient 2’s blood pressure documented blood pressure parameters. RN1 stated he should have rechecked Patient 2’s blood pressure. The HHA failed to ensure Patient 2’s blood pressure was reassessed as indicated in her plan of care. A review of HHA’s policy and procedure titled “Plan of Treatment” undated, indicated “A home health agency has established policies and procedures for assuring that services and times to be provided are specified under a plan of treatment established and regularly reviewed by the physician responsible for the care of each patient and singed within 20 days. The health professional is expected to bring to the attention of the physician, those changes in the patient’s condition which indicate the need for altering the treatment plan or for termination services.”

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on observation, interview, and record review the registered nurse failed to perform supervisory visits for License Vocational Nurse (LVN) services for one of seven sampled patients (Patient 4) provided LVN services. This deficient practice resulted in the LVN not be evaluated for patient care and services. A review of Patient 4’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/4/2023 -2/1/2023, indicated a start of care date on 5/9/207, with a primary diagnosis of epilepsy (seizures). During a concurrent observation, interview, and record review during the home visit on 1/24/2024, at 8:45 a.m., Licensed Vocational Nurse 2 (LVN 2) reviewed Patient 4’s home medications using record titled, “Medication Profile”, dated 12/22/2023. The following medications were not updated in Patient 4’s “Medication Profile”: “Clobazam” (to prevent convulsions-involuntary body movements caused by the brain) 20 mg (mg-milligram, unit of measurement) take ½ (half) tablet by mouth every morning and 1 tablet every evening. The medication profile indicated a 10 mg tablet to be taken twice a day. LVN 2 stated the medication profile did not indicate the dosage and instructions according to the label. The label and the medication profile did not match. LVN 2 stated it was important for the instructions on the label match the medication profile so there are no medication errors. LVN 2 stated it was the responsibility of the Registered Nurse (RN) to update the medication profile. LVN 2 stated, “I just report if there is a change”. “Risperidone” (to threat psychotic (mental disorder) episodes). There were two bottles of the medication. One bottle had a label to take 0.5 mg tablet by mouth every morning. The second bottles were to take 1 mg by mouth every evening. LVN 2 stated the medication profile did not indicate the 0.5 mg dose and the instructions on how to take the medication were not correct in the medication profile. “Vitamin D3” (a supplement) 125 mcg (mcg-micrograms). LVN 2 stated the vitamin was not listed in the medication profile. Vitamin D as listed, patient 4 was no longer taking. During an interview on 1/24/2024 at 12:50 p.m., Registered Nurse 1 (RN1), stated patients’ medication should be reconciliated every time there is a skilled nurse visit to make sure there is no changed in medications or patient condition. RN1 stated if medication reconciliation is not done, “we might not be aware of any changes with patients”. During an interview on 1/25/2024, at 10:52 a.m., RN 1 stated the last time LVN 2 was supervised was on 12/22/2023. RN 1 stated LVN’s were supervised every month. RN 1 stated supervisory visits were important to make the sure LVN was following the plan of care and get updates for any changes. A record review of Patient 4’s record titled, “LVN Supervisory Visit”, dated 12/22/2023, indicated a supervisory visit was done however, the document did not specify if it was LVN 2 being supervised. The HHA failed to ensure LVN 2 was supervised every 30 days to make sure LVN 2 was reviewing the medication and updating the Medication Profile to ensure the HHA was aware of all the current medications Patient 4 was taking.

Competency evaluation CFR(s): 484.80(c)(1)(2)(3) Standard: Competency evaluation. An individual may furnish home health services on behalf of an HHA only after that individual has successfully completed a competency evaluation program as described in this section. (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation. (2) A home health aide competency evaluation program may be offered by any organization, except as specified in paragraph (f) of this section. (3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure competency evaluation must be performed by a registered nurse in consultation with other skilled professionals providing services for two of the seven (Patient 4 and Patient 5) sampled patients care staff, prior to working independently. This deficient practice had the potential to result in health status decline for the patients by not ensuring the staff were competent to provide care. 1. A review of Patient 4’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/4/2023 -2/1/2023, indicated a start of care date on 5/9/207, with a primary diagnosis of epilepsy (seizures). During a concurrent observation, interview, and record review during the home visit on 1/24/2024, at 8:45 a.m., Licensed Vocational Nurse 2 (LVN 2) reviewed Patient 4’s home medications using record titled, “Medication Profile”, dated 12/22/2023. The following medications were not updated in Patient 4’s “Medication Profile”: “Clobazam” (to prevent convulsions-involuntary body movements caused by the brain) 20 mg (mg-milligram, unit of measurement) take ½ (half) tablet by mouth every morning and 1 tablet every evening. The medication profile indicated a 10 mg tablet to be taken twice a day. LVN 2 stated the medication profile did not indicate the dosage and instructions according to the label. The label and the medication profile did not match. LVN 2 stated it was important for the instructions on the label match the medication profile so there are no medication errors. LVN 2 stated it was the responsibility of the Registered Nurse (RN) to update the medication profile. LVN 2 stated, “I just report if there is a change”. “Risperidone” (to threat psychotic (mental disorder) episodes). There were two bottles of the medication. One bottle had a label to take 0.5 mg tablet by mouth every morning. The second bottles were to take 1 mg by mouth every evening. LVN 2 stated the medication profile did not indicate the 0.5 mg dose and the instructions on how to take the medication were not correct in the medication profile. “Vitamin D3” (a supplement) 125 mcg (mcg-micrograms). LVN 2 stated the vitamin was not listed in the medication profile. Vitamin D as listed, patient 4 was no longer taking. During an interview on 1/24/2024 at 12:50 p.m., Registered Nurse 1 (RN1), stated patients’ medication should be reconciliated every time there is a skilled nurse visit to make sure there is no changed in medications or patient condition. RN1 stated if medication reconciliation is not done, “we might not be aware of any changes with patients”. During a concurrent interview and record review on 1/25/2024, at 1:05 p.m., the Administrator (ADM) reviewed LVN 2’s employee file records titled, “Skills Inventory RN/LV Only”, dated 5/9/2027, and “Test of General Knowledge-(RN/LVN) Skilled Nurse”, dated 5/9/2017. The ADM stated there was no initial competency evaluation for LVN 2, the only thing done was a knowledge exam. The ADM stated the exam mostly tested for medication knowledge and LVN 2 had not passed the exam. The ADM stated it was the responsibility of the Registered Nurse Supervisor or the Director of Patient Care services to ensure skill and knowledge competency were done. Ensuring staff are competent and knowledgeable were important because if not done, patients can be put in danger by not ensuring the staff were proficient with their skills. 2. A review of Patient 5’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 11/25/2023-1/23/2024, indicated a start of care date on 5/29/2023, with a primary diagnosis of cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). During a concurrent interview and record review on 1/25/2024, at 12:45 p.m., the ADM reviewed Certified Home Health Aide and Patient 5’s caregiver (CHHA/CG 3) employee file. The ADM stated CHHA/CG 3 did not have a competency evaluation. The ADM stated an observation of the CHHA/CG 3’s skills should have also occurred, and this too was not done. The ADM stated it was important to check the CHHA/CG 3’s skill for the safety of the patient. To make sure CHHA/CG 3 was proficient in his scope of practice. A review of HHA’s policy and procedure titled “Assessing Competency for Clinical Staff” undated, indicated “The clinical staff shall take be evaluated with an ongoing demonstration checklist of skills at their scope of practice. The clinical staff shall be assessment annually for ongoing evaluation of competency.”

12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This STANDARD is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure two of seven sample patients (Patient 1 and Patient 2) provided Certified Home Health Aide (CHHA) services completed the 12 hours in services every 12 months as required. This failure had the potential to result in placing the patients being taken care of CHHAs at risk of being taken care of improperly which may cause harm or damage that may lead to hospitalization. A review of Patient 1's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 2/2/2010 with diagnosis including autistic disorder (a neurological and developmental disorder that affects interactions with others, communication, learning, and behavior). A review of Patient 2's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 12/3/2014 with diagnoses including cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). During a joint home visit on 1/24/2024 at 12 p.m., with CHHA/Care Giver 1 (CHHA/CG1) to Patient 1 and Patient 2’s home, CHHA/CG1 stated she has not attended any in services in the last six months. CHHA/CG1 stated she was Patient 1's and Patient 2’s CHHA and care giver. During a concurrent interview and record review on 1/25/2024 at 11:46 a.m., with the Administrator (ADM) of CHHAs in service binder, ADM stated there were no documented in services for CHHA/CG1 for the year 2023. ADM stated they were using an electronic system to assign CHHA classes/in services. The HHA generated the assign course, then generated an in-house certificate with their letterhead. ADM stated that they sent their generated certificates to their CHHA to sign. ADM stated CHHA need to be in serviced to ensure that they’re in line with the plan of care and that they stay proficient. Also, to keep the lines of communication open between the HHA and their CHHA. A review of HHA’s policy and procedure titled “In Services Education” undated, indicated “In-services will be presented each month to develop and enhanced skills, broaden knowledge specific to home health. At least 12 hours annually provided for CHHA’s".

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on interview and record review the HHA failed to ensure four of seven sampled patients (Patient 1, Patient 2, Patient 3, and Patient 4) entries in the clinical records must be signed by the primary author who reviewed and approved the entries. This failure resulted in an incomplete medical record. 1. A record review of Patient 1's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 2/2/2010 with diagnosis including autistic disorder (a neurological and developmental disorder that affects interactions with others, communication, learning, and behavior). A review of Patient 1 medical record form titled “Hours Worked: Horas Trabajadas:” dated 1/14/2024 to 1/20/2024, indicated section “Aides name” had CHHA/CG1’s name printed on form. It also indicated form was not signed by CHHA/CG1. 2. A review of Patient 2's medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 12/3/2014 with diagnosis including cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). A review of Patient 2 medical record form titled “Hours Worked: Horas Trabajadas:” dated 1/14/2024 to 1/20/2024, indicated section “Aides name” had CHHA/CG1’s name printed on form. It also indicated form was not signed by CHHA/CG1. 3. A review of Patient 3 medical record form titled “Home Health Certification and Plan of Care” dated 11/28/2023 – 1/26/2024, indicated start of care date 12/8/2021 with diagnoses including congenital tracheomalacia (weakness of the walls of the windpipe). A review of Patient 3 medical record form titled “Hours Worked: Horas Trabajadas:” dated 1/14/2024 to 1/20/2024, indicated section “Aides name” had CHHA/CG2’s name printed on form. It also indicated form was not signed by CHHA/CG2. During a concurrent interview and record review on 1/25/2024 at 10:22 a.m., with the Administrator (ADM) of Patient 1, Patient 2, and Patient 3’s CHHA visit notes, ADM stated he knows which discipline wrote the patient visit notes because they send their notes to the HHA via their personal email. ADM stated that the HHA makes sure the patients visit notes are coming from the visiting nurses’ emails and that they also look at their patterns. ADM stated, “we authenticate the note because we know who sent it and where it’s coming from.” ADM stated the CHHA notes are not authenticated, on their own. 4. A review of Patient 4’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/4/2023 -2/1/2023, indicated a start of care date on 5/9/207, with a primary diagnosis of epilepsy (seizures). During a concurrent interview and record review on 1/23/2024, at 12:20 p.m., Licensed Vocational Nurse 1 (LVN 1), reviewed Patient 4’s record titled, “Skilled Nursing Visit Note”, dated 1/13/2024. The record indicated a typed or electronic entry with Licensed Vocational Nurse 2 (LVN 2)’s name and initials. There was no signature. LVN 1 stated the document did not have the nurse’s signature. During an interview on 1/24/2024, at 8:55 a.m., LVN 2 stated he typed in his initials and name into nursing notes but this was not considered his signature. LVN 2 stated, “yes, I think the notes should have my signature, but the capability was not provided by the agency”. LVN 2 stated the importance of including a signature in the notes is to be held responsible for what is documented. To show the documentation was done by him, to show he was the author of the note.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure patients' clinical records are protected/safeguarded against unauthorized use for seven of seven sampled patients (Patient 1, Patient 2, Patient 3, and Patient 4, Patient 5, Patient 6, and Patient 7) by failing to: -Ensure Certified Home Health Aides (CHHA) and Licensed Vocational Nurses (LVN) were restricted to store confidential patients' visit notes and other sensitive patients' information in their personal cell phone, laptop and/or tablet. This failure had the potential to result in patients personal and confidential information being accessed by unknown individual/s. 1. A record review of Patient 1 medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 2/2/2010 with diagnoses including autistic disorder (a neurological and developmental disorder that affects interactions with others, communication, learning, and behavior). Form also indicated it had the HHA’s Electronic System (ES) title/name printed on the left bottom of the forms. A review of Patient 1 medical record form titled “Hours Worked: Horas Trabajadas:” dated 1/14/2024 to 1/20/2024, indicated section “Aides name” had CHHA/CG1’s name printed on form. It also indicated form was not signed by CHHA/CG1. A review of Patient 1’s medical record from titled “OASIS-E Recertification” dated 12/7/2023, indicated it had the HHA’s Electronic System (ES) title/name printed on the left bottom of the forms. 2. A review of Patient 2 medical record form titled “Home Health Certification and Plan of Care” dated 12/16/2023 – 2/13/2024, indicated start of care date 12/3/2014 with diagnoses including cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). Form also indicated it had the HHA’s Electronic System (ES) title/name printed on the left bottom of the forms. A review of Patient 2 medical record form titled “Hours Worked: Horas Trabajadas:” dated 1/14/2024 to 1/20/2024, indicated section “Aides name” had CHHA/CG1’s name printed on form. It also indicated form was not signed by CHHA/CG1. A review of Patient 2’s medical record from titled “OASIS-E Recertification” dated 12/7/2023, indicated it had the HHA’s Electronic System (ES) title/name printed on the left bottom of the forms. 3. A review of Patient 3 medical record form titled “Home Health Certification and Plan of Care” dated 11/28/2023 – 1/26/2024, indicated start of care date 12/8/2021 with diagnoses including congenital tracheomalacia (weakness of the walls of the windpipe). Form also indicated it had the HHA’s Electronic System (ES) title/name printed on the left bottom of the forms. A review of Patient 3 medical record form titled “Hours Worked: Horas Trabajadas:” dated 1/14/2024 to 1/20/2024, indicated section “Aides name” had CHHA/CG2’s name printed on form. It also indicated form was not signed by CHHA/CG2. A review of Patient 3’s medical record from titled “OASIS-E Recertification” dated 11/4/2023, indicated it had the HHA’s Electronic System (ES) title/name printed on the left bottom of the forms. 4. A review of Patient 4’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/4/2023 -2/1/2023, indicated a start of care date on 5/9/207, with a primary diagnosis of epilepsy (seizures). During an interview on 1/24/2024, at 8:55 a.m., Licensed Vocational Nurse 2 (LVN 2) stated the HHA provided an electronic template to him, via electronic mail to document his visit notes. LVN 2 stated he did not need to log in to access the form. Once the nursing visit was completed, LVN 2 would email the note from his personal email address to the HHA email. During an interview on 1/25/2024, at 10:00 a.m., the ADM stated clinical records in employee’s personal cell phone and/or personal computer device were safeguarded because their devices required a password to access their device. 5. A review of Patient 5’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 11/25/2023-1/23/2024, indicated a start of care date on 5/29/2023, with a primary diagnosis of cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). A review of Patient 5’s medical record from titled “OASIS-E Recertification” dated 11/15/2023, indicated “Electronically Signed…” 6. A review of Patient 6’s medical record titled, “OASIS-E Transfer Discharge”, dated 11/30/2023, indicated a start of care date on 11/15/2023, with diagnoses including cerebral palsy (impaired muscle coordination caused by damage to the brain before or at birth). Further review of the record indicated, “Electronically Signed…” 7. A review of Patient 7’s medical record titled, “OASIS-E Transfer Discharge”, dated 8/22/2023, indicated a start of care date on 7/23/2023, with diagnoses including chronic respiratory failure (difficulty breathing). Further review of the record indicated, “Electronically Signed…” During an interview on 1/23/2024 at 10:33 a.m., with Medical Record (MR), MR stated the HHA has an Electronic Medical Record (EMR) system, but that the system does not print out a census. During an interview on 1/23/2024 at 10:40 a.m., with Registered Nurse 1 (RN1), RN1 was made aware of needed current patient census document from their EMR. RN1 stated “let me see what I can do.” During an interview on 1/23/2024 at 10:50 a.m., with the Administrator (ADM), ADM stated the HHA does not have an EMR, therefore patients have hard files. ADM stated when a nurse completes a physical assessment, she/he enters the information into their HHA electronic system (ES) and from there patients’ initial assessments, ongoing assessments, plan of care, and communication notes are generated. During a concurrent interview and record review on 1/23/2024at 11:05 a.m., with RN1 of HHA patient census form titled “Census by Date Range” dated 1/1/2024-1/23/2024, RN1 provided and stated census form was generated from their EMR system. During an interview on 1/23/2024 at 12:21 p.m., with License Vocational Nurse 1 (LVN1), LVN1 stated Certified Home Health Aides (CHHA) document patient visit notes in a template on their personal cell phone, laptop, or tablet. LVN1 stated once a CHHA fills out the template, they send it to the HHA via email. During an observation and interview on 1/24/2024 at 12:30 p.m., with Certified Home Health Aide/Care Giver 1 (CHHA/CG1), CHHA/CG 1 noted using a tablet to demonstrate where she documents Patient 1 and Patient 2’s visit. CHHA/CG 1 stated she documents her assessment in her tablet daily using a drop box. CHHA/CG1 stated the HHA receives the documentation instantly. During an interview on 1/24/2024 at 12:50 pm., with RN1, RN 1 stated CHHAs have a PDF form in the drop box that they document their visit notes. RN1 stated a drop box is an online forum. RN1 stated, “We create a patient profile in the drop box, then access is given to different people to document on or attach their assessment notes. Once they document on the form, we print it out and place it in the patient’s file.” RN1 stated that if the form is in a PDF format, the CHHAs can put in their electronic signature. A review of HHA’s policy and procedure titled “Workstation Use and Security – When using AXXESS” undated, indicated “Workforce members will be instructed not to share passwords with others, except to assure business continuity. (HHA) will implement additional precautions for portable workstations that store ePHI. Workforce members will not store ePHI on unencrypted workstations.

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 Home Health Agency (HHA) failed to ensure low oxygen saturation rate (measures the percentage of oxygen level in the blood. Normal range from 95 to 100 percent) was reported to the physician, for one of seven sampled patients (Patient 9), when Patient 9 was diagnoses with Asthma (a respiratory condition marked by spasms in the bronchi of the lungs, causing difficulty in breathing) and chronic respiratory failure. This deficient practice had a potential to delay obtaining proper orders from the physician to provide necessary treatment/care to Patient 9 to prevent further respiratory/systemic distress. Findings: Patient 9's record was reviewed. The forms titled "Home Health Certification and Plan of Care (POC)", for the certification period from 5/9/2021 to 7/7/2021, and from 7/8/2021 to 9/5/2021 indicated a start of care (SOC) date of Patient 9 was 2/27/2013, with diagnoses which included cerebral palsy (a congenital disorder of movement, muscle tone resulting in muscular spasm and abnormal posture), asthma, and chronic respiratory failure with hypoxia (low oxygen in the blood) or hypercapnia (a buildup of carbon dioxide in the bloodstream caused by not enough oxygen enters the lungs). A review of Patient 9's POC indicated orders for Registered Nurse Case Manager (RNCM) hours up to 2 hours, Licensed Vocational Nurse (LVN) hours from 115 to 230 hours per month, and the certified home health aide (CHHA) hours from 187.5 to 375 hours per month. The POC indicated to utilize oxygen at two liters per minute via nasal cannula as needed for oxygen saturations less than 92 percent. The RNCM was to provide education to the primary caregiver on methods to recognize pulmonary (lung) dysfunction and relieve complication. During an observation of a home visit conducted on 8/23/2021, at 2 p.m., at Patient 9's home, Patient 9 was observed sitting in a reclining wheelchair receiving oxygen at 4 liters per minute via nasal canulla. CHHA 5/Patient 9's Family member was next to the patient. A review of the untitled CHHA note/time sheet dated 8/1/2021 (time was not written) indicated Patient 9's oxygen saturation rate was 80 percent. On 8/25/2021, at 1:30 p.m., during an interview with LVN 5/quality assurance (QA) nurse, LVN 5/QA nurse stated she found out that Patient 9's oxygen saturation rate was 80 percent on 8/1/2021. LVN 5/QA nurse stated she could not provide the documentation that CHHA 5/Patient 9's Family member had reported Patient 9's low oxygen saturation to the physician or the agency. LVN 5/QA nurse stated CHHA 5/Patient 9's Family member should have notified the physician or the agency on 8/1/2021 when Patient 9's oxygen saturation was 80 percent. LVN 5/QA nurse further stated that the parameter of oxygen saturation rate to be reported to the physician or the agency is below 90 percent. During an interview with the Administrator/Director of Patient Care Services (DPCS), he stated the agency staff should have notified the physician regarding Patient 9's oxygen saturation rate (80 percent) on 8/1/2021. A review of the agency's undated policy and procedure titled, "Standard Vital Signs Ranges unless otherwise specified by MD order," indicated to consider consulting your doctor when the oxygen saturation is 90 percent or less. A review of the agency's undated policy and procedure titled, "Plan of Care," indicated it is the staff member's responsibility to report any condition or problems to the physician.

The following reflects the findings of the California Department of Public Health during a Recertification Survey from 6/7/2021 to 6/11/2021. Representing the Department of Public Health: Surveyor ID # 25046, RN, Health Facilities Evaluator Nurse Surveyor ID # 36459, RN, Health Facilities Evaluator Nurse Surveyor ID # 34510, RN, Health Facilities Evaluator Nurse Surveyor ID # 38243, RN, Health Facilities Evaluator Nurse Number of unduplicated admissions for the past 12 months: 27 Active patients: 189 Sample Size - 7 Patients Unsampled - 1 Patient Home Visits - 3

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health agency (HHA) agency failed to meet the Condition of Participation regarding Establishment of The Emergency Program as follows: 1. The HHA failed to develop and maintain an emergency preparedness plan that is reviewed and updated at least every two years. (Refer to E 004) 2. The HHA failed to develop and maintain a training program for the agency staff to ensure each employee is able to perform their duties in the event of an emergency or disaster. (Refer to E 0037) 3. The Home Health Agency (HHA) failed to conduct testing activities for the agency's Emergency Preparedness Program to ensure the agency staff aware of their duties in the event of an emergency or disaster. (Refer to E 0039) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to develop and maintain an emergency preparedness plan that is reviewed and updated at least every two years. The deficient practice has the potential to affect the safety of the patients and put them at risk of danger during an emergency or disaster. Findings: On 6/10/2021, at 3:35 p.m., a request of the agency's Emergency Preparedness Program was made. A seven-pages undated policy and procedure titled, "Emergency Information," were provided by the Administrator/Director of Patient Care Services (DPCS). There were no logs found in the policy and procedure provided. During a concurrent interview and documents review with the Administrator/DPCS, the Administrator/DPCS stated that the Emergency Preparedness Program was reviewed and revised annually. However, the Administrator/DPCS stated he was not able to provide any logs or documented evidence to show that the Emergency Preparedness Program was reviewed and revised annually. A review of the agency's undated policy and procedure titled, "Emergency Plan," did not indicate the frequency for developing and maintaining an Emergency Preparedness Program.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to develop and maintain a training program for the agency staff to ensure each employee is able to perform their duties in the event of an emergency or disaster. This deficient practice has the potential to affect the safety of the patients and put them at risk for delayed services when staff are not efficient in providing care to patients in a timely manner in the event of an emergency or disaster. Findings: On 6/10/2021, at 3:35 p.m., a request of the agency's Emergency Preparedness Program was made. A seven-pages undated policy and procedure titled, "Emergency Information," were provided by the Administrator/Director of Patient Care Services (DPCS). There were no logs found in the policy and procedure provided. During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 4:20 p.m., the Administrator/DPCS stated that the emergency preparedness training and education for staff is conducted monthly. However, the Administrator/DPCS stated he was not able to provide any logs or documented evidence to show that the emergency preparedness training and education for staff is conducted monthly. A review of the agency's undated policy and procedure titled "Emergency Plan," did not address the frequency for training and educating staff in emergency preparedness.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to conduct testing activities for the agency's Emergency Preparedness Program to ensure the agency staff aware of their duties in the event of an emergency or disaster. This deficient practice has the potential to affect the safety of the patients and put them at risk for delayed services when staff are not efficient in providing care to patients in a timely manner in the event of an emergency or disaster. Findings: On 6/10/2021, at 3:35 p.m., a request of the agency's Emergency Preparedness Program was made. A seven-pages undated policy and procedure titled, "Emergency Information," were provided by the Administrator/Director of Patient Care Services (DPCS). There were no logs found in the policy and procedure provided. During a concurrent interview and documents review with the Administrator/DPCS, the Administrator/DPCS stated that the emergency preparedness drills were conducted. However, the Administrator/DPCS stated he was not able to provide any logs or documented evidence to show that the the emergency preparedness drills were conducted. A review of the agency's undated policy and procedure titled, "Emergency Plan," did not indicate the frequency that the agency conducts testing on emergency preparedness plan.

The following reflects the findings of the California Department of Public Health during a Recertification Survey from 6/7/2021 to 6/11/2021. Representing the Department of Public Health: Surveyor ID # 25046, RN, Health Facilities Evaluator Nurse Surveyor ID # 36459, RN, Health Facilities Evaluator Nurse Surveyor ID # 34510, RN, Health Facilities Evaluator Nurse Surveyor ID # 38243, RN, Health Facilities Evaluator Nurse Number of unduplicated admissions for the past 12 months: 27 Active patients: 189 Sample Size - 7 Patients Unsampled - 1 Patient Home Visits - 3

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Comprehensive Assessment of Patients as follows: 1. The HHA failed to ensure the initial comprehensive assessments were completed, for six of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 6, and Patient 7) and one unsampled patient (Patient 8). (Refer to G 526) 2. The HHA failed to review and update the "Medication Profile" (the information about the medicines a person is using and has used) for one of seven sampled patient (Patient 4). (Refer to G 536) 3. The HHA failed to conduct a comprehensive assessment, for one of seven sampled patients (Patient 1), when Patient 1 was admitted to the HHA and discharged from the general acute care hospital. (Refer to G 544) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the initial comprehensive assessments were completed, for six of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 6, and Patient 7) and one unsampled patient (Patient 8).This deficient practice resulted in Patient 1 admitted to the general acute care hospital (GACH). This deficient practice had a potential to result in lacking in information of the patients' condition to address and meet their needs. Findings: a) Patient 1's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 10/27/2020 to 12/25/2020, indicated the start of care (SOC) date for Patient 1 was 9/3/2019, with diagnoses which included cerebral palsy (a congenital disorder of movement, muscle tone, or posture), dystonia (abnormal muscle tone resulting in muscular spasm and abnormal posture), and gastrostomy (surgical creation of an opening into the stomach for food, medicines, and/or drainage) status. A review of Patient 1's Outcome and Assessment Information Set (OASIS - The instrument/data collection tool used to collect and report assessment data by home health agencies), dated 9/3/2019, manually completed and signed by Registered Nurse 1 (RN 1), indicated there were no vital signs recorded in the OASIS. The height for Patient 1 was documented as "5 inches" and the weight was 64 pounds. During a telephone interview with RN 1on 6/9/2021, at 2:10 p.m., RN 1 stated she did not measure Patient 1's height and weight. RN 1 stated she was told by Patient 1's family member (Certified Home Health Aide 1 [CHHA 1]/ Patient 1's Family Member) of Patient 1's height and weight, and recorded them in the OASIS. RN 1 stated she assessed Patient 1's vital signs, but she did not document them in the OASIS. A review of another set of OASIS for Patient 1, dated 9/3/2019, electronically completed and signed by Registered Nurse 2 (RN 2), indicated there were no vital signs, no height, and weight in the OASIS. During a telephone interview with RN 2 on 6/10/2021, at 11:55 a.m., RN 2 stated she was Patient 1's RN case manager and she has been working out of the country remotely since April 2021. RN 2 stated she completed Patient 1's OASIS electronically by using RN 1's OASIS information and follow-up call with Patient 1's family. A review of the Certified Home Health Aide (CHHA) notes, dated from 12/6/2020 to 12/11/2020, indicated there were no "check marks" or documentation for Patient 1' vital signs and elimination status. During a telephone interview with Patient 1's CHHA 1/Patient 1's Family Member on 6/9/2021, at 2:20 p.m., CHHA 1/Patient 1's Family Member stated Patient 1's weight was not assessed by the HHA's staff from admission (9/3/2019) to discharge (12/16/2020). Patient 1's hospital record was reviewed. The "Physician Discharge Summary," dated 12/29/2020, indicated Patient 1 was admitted to the hospital on 12/12/2020, with diagnosis of severe constipation leading to feeding intolerance and aspiration pneumonia (a lung infection caused by inhaled oral or gastric contents). A review of the Discharge OASIS, dated 12/16/2020, electronically signed by Licensed Vocational Nurse 1 (LVN 1), indicated there were no documentation for Patient 1's vital signs and condition at discharge. During an interview and a concurrent record review with LVN 1 on 6/10/2021, at 12:40 p.m., LVN 1 stated she was not able to find the documented evidence that a comprehensive assessment was performed for Patient 1. During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 3:15 p.m., the Administrator/DPCS stated he did not know Patient 1's ideal body weight or goal weight, and stated the agency did not have a registered dietician. The Administrator/DPCS stated the POC should have included Patient 1's weight management including the goal of Patient 1's weight management. b) Patient 2's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 4/30/2021 to 6/28/2021, indicated the start of care (SOC) date for Patient 1 was 8/13/2014, with diagnoses which included congenital central alveolar hypoventilation syndrome (a disorder that affects normal breathing), tracheostomy status (an artifical opening direct to the windpipe), and gastrostomy (a surgical creation of an opening into the stomach for food, medicines, and/or drainage) status. A review of an Initial Assessment, dated 8/13/2014, indicated the spaces for blood pressure, height and weight were blank. c) Patient 3's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 4/24/2021 to 6/22/2021, indicated the start of care (SOC) date for Patient 3 was 3/21/2016, with diagnoses which included disorders of lung and chromosomal abnormality (an error in cell division). A review of the OASIS, dated 3/21/2016, indicated there were no vital signs documented. The space for vital signs and the space for vital signs parameter were blank. The space for height and weight were also blank. During a home visit on 6/8/2021, at 11:35 a.m., Patient 3 was observed sitting on the floor and CHHA 4/Patient 3's Family Member was preparing lunch for Patient 3. During an interview with CHHA 4/Patient 3's Family Member on 6/8/2021, at 12 p.m., CHHA 4/Patient 3's Family Member stated the HHA's staff did not assess Patient 3's height and weight; however, the HHA's staff had asked her for Patient 3's height and weight. CHHA 4/Patient 3's Family Member stated she did not even have a scale at home, and the HHA did not worry about Patient 3's weight. d) Patient 4's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 5/13/2021 to 7/11/2021, indicated the start of care (SOC) date for Patient 4 was 7/23/2019, with diagnosis of epilepsy (disorder in which brain activity becomes abnormal, causing seizures or periods of unusual behavior, sensations, and sometimes loss of awareness). A review of Patient 4's OASIS, dated 7/23/2019, indicated that there were no vital signs, height or weight documented. e) Patient 6's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 4/2/2021 to 5/31/2021, indicated the start of care (SOC) date for Patient 6 was 8/5/2020, with diagnosis of metachromatic leukodystrophy (a disorder that causes fatty substances to build up in cells, particularly in the brain, spinal cord and peripheral nerves). A review of Patient 6's OASIS, dated 8/5/2020, indicated that there were no vital signs, height or weight documented. f) Patient 7's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 4/22/2021 to 6/20/2021, indicated the start of care (SOC) date for Patient 7 was 10/30/2019, with diagnosis of spastic quadriplegic cerebral palsy (loss of use of the whole body). A review of Patient 7's OASIS, dated 10/30/2019, indicated that there were no vital signs, height or weight documented. g) Patient 8's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 11/6/2020 to 1/4/2021, indicated the start of care (SOC) date for Patient 8 was 3/11/2020, with diagnosis of cerebral palsy (a group of disorders that affect a person's ability to move and maintain balance and posture). A review of Patient 8's OASIS, dated 3/11/2020, indicated that there were no vital signs, height or weight documented. During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 2:30 p.m., the Administrator/DPCS stated the vital signs should have been assessed using parameters and weight should have been assessed. A review of the agency's undated policy and procedure titled, "RN Case Manager," indicated to obtain a complete health history and perform head to toe physical exam upon admission. A review of the agency's undated policy and procedure titled, "Vital Signs," indicated the vital signs shall be taken on admission, every visit/shift, and more frequently as dictated by the physician order and condition of the patient. A review of the undated agency's policy and procedure titled, "Assessment Methods," indicated, " ... 8. Additional assessment considerations ... b. Weight - weight loss, weight gain, extremely underweight (cachectic), abnormal thinness (emaciated), wasting, obese ..."

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 home health agency (HHA) failed to review and update the "Medication Profile" (the information about the medicines a person is using and has used) for one of seven sampled patient (Patient 4). This failure resulted in lacking in communication between Patient 4's family member and the agency regarding Patient 4's updated medications/nutrition orders. This failure also has a potential to result in ineffective drugs therapy and medications interaction. Findings: Patient 4's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 5/13/2021 to 7/11/2021, indicated the start of care (SOC) date for Patient 4 was 7/23/2019, with diagnosis of epilepsy (disorder in which brain activity becomes abnormal, causing seizures or periods of unusual behavior, sensations, and sometimes loss of awareness). The POC indicated Patient 4 receives Nutren Jr. (nutritional supplement) six cans per day via gastrostomy tube (GT, a tube inserted through the belly that brings nutrition directly to the stomach) bolus (a single dose of a drug or other substance given over short period of time) every four hours; and water bolus 250 milliliter (ml, unit of measurement) four times per day. A home visit was conducted on 6/8/2021, at 12 p.m. for Patient 4. During an observation and a concurrent medication reconciliation with Patient 4's caregiver (Physician 1 [PHY 1] /Patient 4's Family Member), PHY 1/Patient 4's Family Member showed the bottles of medications Patient 4 were currently taking. The following medications were not listed on Patient 4's current "Medication Profile" for the certification period from 5/13/2021 to 7/11/2021: Topamax (a medication to treat and prevent seizures) 25 milligram (mg, a unit of measurement) tablets, give three tablets in the morning and four tablets in the evening via GT; Banzel (a medication to treat and prevent seizures) 400 mg tablets, give one tablet in the morning and one and a half tablets via GT in the evening; Keppra (a medication to treat and prevent seizures) 100 mg/ml bottle, give 11 ml via GT twice a day. These medications were recently refilled on 3/22/2021. During an interview and a concurrent review of Patient 4's "Medication Profile," with the certification period from 5/13/2021 to 7/11/2021, with PHY 1/Patient 4's Family Member on 6/8/2021, at 12:40 p.m., , PHY 1/Patient 4's Family Member stated "this is very old." PHY 1/Patient 4's Family Member stated Patient 4's enteral nutrition was also changed to Nutren 1.0 (a tube feeding formula), 250 mg/can: to give seven cans total per day (two cans three times a day plus another one can extra to total seven cans/day). PHY 1/Patient 4's Family Member further stated Patient 4's water flushes for the GT decreased to 250 ml twice a day since the Nutren was changed. During further interview with Patient 4's family member (FM 9), FM 9 stated the enteral feeding and water flushes were changed before the pandemic around December 15, 2019. During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 2:20 p.m., the Administrator/DPCS stated that the medication profile is reviewed every 60 days by Registered Nurse Case Manager (RNCM). The Plan of Care is created by the RNCM, and the Medication Profile will be updated by the RNCM or the office staff. The Administrator/DPCS further stated Medication Profile is doubled check by another RNCM or assistant case manager. A review of the HHA's undated policy and procedure titled, "Administering Medication & Profile," indicated, "The RN will be responsible for monitoring the patient's medication regimen through a collaborative effort with the multi-disciplinary team and physician involved in the patient's care. 1. An accurate and current list of all prescription and over-the-counter (OTC) medications taken by the patient will be maintained on the medication profile .... 3. Nursing staff will assess on an ongoing basis the patient's response to the medication and the patient/caregiver's compliance with the medication regimen .... 5. Changes in the medication regimen will be documented in the clinical record as well as communicated to the patient and/or caregiver. 6. Review of medications will be on-going, but done a minimum of every 60 days."

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health agency (HHA) failed to conduct a comprehensive assessment, for one of seven sampled patients (Patient 1), when Patient 1 was admitted to the HHA and discharged from the general acute care hospital (GACH). This deficient practice resulted in lacking in information to develop the plan of care that meet Patient 1's needs. Patient 1 admitted to the GACH three times while receiving the services from the HHA. Findings: Patient 1's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 10/27/2020 to 12/25/2020, indicated the start of care (SOC) date for Patient 1 was 9/3/2019, with diagnoses which included cerebral palsy (a congenital disorder of movement, muscle tone, or posture), dystonia (abnormal muscle tone resulting in muscular spasm and abnormal posture), and gastrostomy (surgical creation of an opening into the stomach for food, medicines, and/or drainage) status. A review of Outcome and Assessment Information Set (OASIS - The instrument/data collection tool used to collect and report assessment data by home health agencies) for Patient 1, dated 9/3/2019, manually completed and signed by Registered Nurse 1 (RN 1), indicated there were no vital signs recorded in the OASIS. The height for Patient 1 was documented as "5 inches" and the weight was 64 pounds. During a telephone interview with RN 1on 6/9/2021, at 2:10 p.m., RN 1 stated she did not measure Patient 1's height and weight. RN 1 stated she was told by Patient 1's family member (Certified Home Health Aide 1 [CHHA 1]/Patient 1's Family Member) of Patient 1's height and weight, and recorded them in the OASIS. RN 1 stated she did not document the vital signs in the OASIS. A review of another set of Patient 1's OASIS, with the same date of 9/3/2019, electronically completed and signed by Registered Nurse 2 (RN 2) indicated there were no vital signs, no height, and weight in the OASIS. A review of Patient 1's record indicated there was no documented evidence that Patient 1's weight has been monitored or recorded after 9/3/2019. Patient 1's hospital record was reviewed. The "Discharge Summary," indicated Patient 1 was admitted to the hospital on 1/16/2020 and discharged on 1/28/2020. The diagnosis was severe malnutrition (lack of sufficient nutrients in the body). Patient 1's agency record was reviewed. There was no documented evidence indicated a comprehensive assessment was conducted for Patient 1 after discharging form the GACH on 1/28/2020 or afterwards. Patient 1's hospital record was reviewed. The "Pediatric Discharge Summary," indicated Patient 1 was admitted to the hospital on 9/17/2020 and discharged on 10/8/2020. The diagnoses were iron deficiency anemia (a condition of too little iron in the body) and severe malnutrition. Patient 1's record was reviewed. There was no documented evidence indicated a comprehensive assessment was conducted for Patient 1 after discharging form the GACH on 10/8/2020 or afterwards. Patient 1's hospital record was reviewed. The "Physician Discharge Summary," indicated Patient 1 was admitted to the hospital on 12/12/2020 with diagnosis of severe constipation leading to feeding intolerance and aspiration pneumonia (a lung infection caused by inhaled oral or gastric contents). During an interview and a concurrent record review with Licensed Vocational Nurse 1 (LVN 1) on 6/10/2021, at 12:40 p.m., LVN 1 stated she was not able to find the documented evidence that a comprehensive assessment, including weight loss assessment, was conducted for Patient 1 after discharging from hospital on 1/28/2020 and 10/8/2020. A review of the agency's undated policy and procedure titled, "The Patient Record, 15. Comprehensive Assessment," indicated, " .. The assigned staff member will assesss the patient's physical and psychosocial status to determine the need, type of care/services and the need for further assessment ... Ongoing assessment will occur with each visit and necessary revision will be made to plan of care ..."

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on interview and record review, the agency failed to meet the Condition of Participation for Care Planning, Coordination Of Services, and Quality Of Care as follows: 1. The Home Health Agency (HHA) failed to follow the Plan of Care that were individually developed for four of seven sampled patients (Patient 1, Patient 4, Patient 6 and Patient 7) and one unsampled patient (Patient 8). (Refer to G 572) 2. The HHA failed to ensure medications were administered according to physician's order for one of seven sampled patients (Patient 2). (Refer to G 580). 3. The HHA failed, for one of seven sampled patients (Patient 4), to ensure the Plan of Care was revised to reflect Patient 4's current nutritional status. (Refer to G 592). 4. The HHA failed to coordinate care and services to meet nutritional needs, for one of seven sampled patients (Patient 1). (Refer to G 608). 5. The HHA failed to ensure the nursing staff teach the caregiver of the intramuscular injection (IM - the injection of a substance into a muscle), for one of seven sampled patients (Patient 3). (Refer to G 610). The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

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 Home Health Agency (HHA) failed to follow the Plan of Care that were individually developed for four of seven sampled patients (Patient 1, Patient 4, Patient 6 and Patient 7) and one unsampled patient (Patient 8). This deficient practice resulted in lacking in information to update the Plan of Care that meet patients' needs when there were changes in patients' condition. This deficient practice also had a potential to result in delaying responses to address patients' needs that promote patients' well-being. Findings: a) Patient 1's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), for the certification period from 3/1/2020 to 4/29/2020, from 4/30/2020 to 6/28/2020, and from 10/27/2020 to 12/25/2020 indicated a start of care (SOC) date of Patient 1 was 9/3/2019, with diagnoses included cerebral palsy (a congenital disorder of movement, muscle tone, or posture), dystonia (abnormal muscle tone resulting in muscular spasm and abnormal posture), and gastrostomy (surgical creation of an opening into the stomach for food, medicines, and/or drainage) status. A review of Patient 1's POCs further indicated orders for Registered Nurse Case Manager (RNCM) up to two hours per month and Certified Home Health Aide (CHHA) from 120 to 240 hours per month. The POC indicated CHHA to monitor for signs and symptoms of shortness of breath of Patient 1 and document oxygen (O2) saturation with vital signs. The order also indicated that CHHA to report to Registered Nurse (RN)/medical doctor (MD) if O2 saturation less than 92 percentage (%). A review of the forms, dated from 3/1/2020 to 10/24/2020, completed by the CHHA 1/Patient 1's Family Member indicated there were check marks for the row of "Vital Signs." There were no documentation of Patient 1's vital signs results and O2 saturation in the forms. A review of the forms, dated from 10/25/2020 to 12/11/2020, completed by the CHHA 1/Patient 1's Family Member indicated there were check marks for the row of "Vital Signs" only found on six days (11/1/2020, 11/8/2020, 11/15/2020, 11/22/2020, 11/29/2020, and 12/6/2020) within the period from 10/25/2020 to 12/11/2020. There were no documentation of Patient 1's vital signs results and O2 saturation in the forms on 11/1/2020, 11/8/2020, 11/15/2020, 11/22/2020, 11/29/2020, and 12/6/2020. During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 2:30 p.m., the Administrator/DPCS stated the patient's vital signs and the oxygen saturation rate should have been assessed and documented in the clinical record. b) A review of Patient 4's Plan of Care (POC), for the certification period from 5/13/2021 to 7/11/2021, indicated a start of care date (SOC) of 7/23/2019, with diagnosis of epilepsy (disorder in which brain activity becomes abnormal, causing seizures or periods of unusual behavior, sensations, and sometimes loss of awareness). A review of Patient 4's POC further indicated to report oxygen saturation less than 92% to physician. Additionally, the Plan of Care indicated that the Registered Nurse (RN) would monitor and document intake and output every shift. A review of Patient 4's Skilled Nursing Notes Visit from 5/13/2021 to 6/5/2021 indicated that there were no documentation for oxygen saturation or intake and output. During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 2:20 p.m., the Administrator/DPCS stated the patient's vital signs, the oxygen saturation rate, and intake and output should have been assessed and documented in the clinical record. During an interview and a concurrent record review with Licensed Vocation Nurse 1 (LVN 1) on 6/11/2021, at 4 p.m., LVN 1 stated there was no documentation for Patient 4's oxygen saturation and intake and output found in the record. c) A review of Patient 6's Plan of Care (POC), for the certification period from 4/2/2021 to 5/31/2021, indicated a start of care date (SOC) of 8/5/2020, with diagnosis of metachromatic leukodystrophy (a disorder that causes fatty substances to build up in cells, particularly in the brain, spinal cord and peripheral nerves). A review of Patient 6's POC further indicated that Licensed Vocational Nurse (LVN) was to monitor and document intake and output every shift. A review of Patient 6's Skilled Nursing Notes Visit from 4/4/2021 to 6/5/2021 indicated that there was no intake and output documented. During an interview with Licensed Vocational Nurse 3 (LVN 3)/Patient 6's Family Member on 6/10/2021, at 12:30 p.m., LVN 3/Patient 6's Family Member stated that he did not document Patient 6's intake and output because he did not know he needed to. During an interview and a concurrent record review with Licensed Vocation Nurse 1 (LVN 1) on 6/11/2021, at 4:05 p.m., LVN 1 stated there was no documentation for Patient 6's intake and output found in the record. d) A review of Patient 7's Plan of Care (POC), for the certification period from 4/22/2021 to 6/20/2021, indicated a start of care date (SOC) of 10/30/2019, with diagnosis of spastic quadriplegic cerebral palsy (loss of use of the whole body). A review of Patient 7's POC further indicated an LVN is to monitor and document frequency, duration and post seizure (convulsion) activity of any seizure. A review of Patient 7's Skilled Nursing Notes Visit from 4/22/2021 to 6/5/2021 indicated that there was no frequency, duration, and post seizure activity documented. During an interview and a concurrent record review with LVN 1 on 6/11/2021 at 4:10 p.m., LVN 1 stated there was no seizure log in Patient 7's record. e) A review of Patient 8's Plan of Care (POC), for the certification period from 11/6/2020 to 1/4/2021, indicated a start of care date (SOC) of 3/11/2020, with diagnosis of cerebral palsy (a group of disorders that affect a person's ability to move and maintain balance and posture). A review of Patient 8's POC further indicated an order for Registered Nurse Case Manager (RNCM) up to two hours per month, Licensed Vocational Nurse (LVN) from 30 to 60 hours per month, and Certified Home Health Aid (CHHA) from 90 to 180 hours per month. Additionally, the POC indicated that RNCM to monitor oxygen saturation and LVN/HHA to monitor and document input and output for elimination and intake and output for nutrition. A review of Patient 8's record indicated that there were no Skilled Nursing Notes found in the record. A review of Patient 8's "30 Day Summary," dated 11/24/2020, completed by LVN 2, indicated that there was no oxygen saturation documented. A review of the forms, dated from 11/6/2020 to 1/4/2021, completed by the CHHA 2/Patient 8's Family Member indicated that there were no input and output for elimination and intake and output for nutrition documented. During an interview and a concurrent record review with Licensed Vocation Nurse 1 (LVN 1) on 6/11/2021, at 4:15 p.m., LVN 1 stated that Patient 8 did not have any oxygen saturation, input and output for elimination and intake and output for nutrition documented. A review of the undated agency's policy and procedure titled, "Plan of Care," indicated, " ...The Plan of Care will serve as a physician's orders for patient care and all staff providing services will be in compliance with and follow the MD orders ..." A review of the undated agency's policy and procedure titled, "Vital Signs," indicated, "Vital signs shall be taken on admission, every visit/shift, and more frequently as dictated by the physician order and condition of the patient ..." A review of the agency's policy and procedure titled, "Home Health Aide," revised on 5/1/2002, indicated, " ...Duties of CHHA include the following ... Checking Vital Signs and report them to the RN supervisor ..."

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 interview and record review, the home health agency (HHA) failed to ensure medications were administered according to physician's order for one of seven sampled patients (Patient 2). This failure resulted in medication error and had the potential for Patient 2 to have adverse health outcomes. Findings: Patient 2's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 4/30/2021 to 6/28/2021, indicated the start of care (SOC) date for Patient 2 was 8/13/2014, with diagnoses which included congenital central alveolar hypoventilation syndrome (a disorder that affects normal breathing), dependence on respirator (ventilator - machine that blow air with extra oxygen into the airways and the lungs) status, gastrostomy (surgical creation of an opening into the stomach for food, medicines, and/or drainage) status and tracheostomy (a surgical opening created at the front of the neck so a tube can be inserted into the windpipe to help breathe) status. A review of Patient 2's Medication Profile, for the care period from 4/30/2021 to 6/28/2021, indicated: a) Acetaminophen (Tylenol - medication for pain and fever) 160 milligram (mg)/5 milliliter (ml) (milligram/milliliter-unit of measurement) oral suspension, give 10 ml for mild pain or temperature above 100.5 degrees Fahrenheit every four hours as needed via feeding tube. b) Ibuprofen (medication for pain and fever) 100 mg/5ml oral suspension, give 10 ml for moderate pain or temperature above 100.5 degrees Fahrenheit every six hours as needed via feeding tube. During an interview with Certified Home Health Aide (CHHA 3)/Patient 2's Family Member on 6/8/2021, at 2 p.m., CHHA 3/Patient 2's Family Member stated she is employed by the HHA and works as a CHHA to take care of her son. CHHA 3/Patient 2's Family Member stated when Patient 2 complains of pain, she mixes 4 ml of Tylenol and 4 ml of Ibuprofen and gives the mixture to Patient 2. CHHA 3/Patient 2's Family Member stated, "I do it that way because I know it will work better. I did not tell the visiting nurse. It's a mother's instinct. I know what works better for my son (Patient 2)." During an interview with Licensed Vocational Nurse 4 (LVN 4) on 6/8/2021, at 2:40 p.m., LVN 4 stated, "I don't educate his (Patient 2) Mom (CHHA 3/Patient 2's Family Member), she knows everything. I am not aware she (CHHA 3/Patient 2's Family Member) was giving 4 ml of Tylenol mixed with 4 ml Ibuprofen." A review of the undated agency's policy and procedure titled, "Plan of Care," indicated, " ...The Plan of Care will serve as a physician's orders for patient care and all staff providing services will be in compliance with and follow the MD (Medical Doctor) orders ..."

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed, for one of seven sampled patients (Patient 4), to ensure the Plan of Care was revised to reflect Patient 4's current nutritional status. This failure had a potential to result in miscommunication among health care providers for Patient 4's nutrional needs. Findings: Patient 4's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 5/13/2021 to 7/11/2021, indicated the start of care (SOC) date for Patient 4 was 7/23/2019, with diagnosis of epilepsy (disorder in which brain activity becomes abnormal, causing seizures or periods of unusual behavior, sensations, and sometimes loss of awareness). The POC indicated Patient 4 receives Nutren Jr. (a tube feeding formula) six cans per day via gastrostomy tube (GT, a tube inserted through the belly that brings nutrition directly to the stomach) bolus (a single dose of a drug or other substance given over short period of time) every four hours; and water bolus 250 milliliter (ml, unit of measurement) four times per day. A home visit was conducted on 6/8/2021, at 12 p.m., for Patient 4. During an interview and a concurrent review of Patient 4's "Medication Profile," with the certification period from 5/13/2021 to 7/11/2021, with PHYSICIAN 1 (PHY 1)/Patient 4's Family Member on 6/8/2021 at 12:40 p.m., , PHY 1/Patient 4's Family Member stated "this is very old." PHY 1/Patient 4's Family Member stated Patient 4's enteral nutrition was also changed to Nutren 1.0, 250 mg/can: to give seven cans total per day (two cans three times a day plus another one can extra to total seven cans/day). PHYS 1/Patient 4's Family Member further stated Patient 4's water flushes for GT decreased to 250 ml twice a day since the Nutren was changed. During further interview with Patient 4's family member (FM 9), FM 9 stated the enteral feeding and water flushes was change before the pandemic around December 15, 2019. A review of the agency's undated policy and procedure titled, "Plan of Care," indicated, "An individualized Plan of Care will be developed for each patient for admitted and reviewed/revised as needed to meet the patient's needs ... 3. The Plan of Care includes: ... 5. Specific diets ..."

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health agency (HHA) failed to coordinate care and services to meet nutritional needs, for one of seven sampled patients (Patient 1). This deficient practice resulted in Patient 1's needs were not addressed and Patient 1 admitted to general acute care hospital three times from 1/16/2020 to 12/29/2020. Findings: Patient 1's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 10/27/2020 to 12/25/2020, indicated the start of care (SOC) date for Patient 1 was 9/3/2019, with diagnoses which included cerebral palsy (a congenital disorder of movement, muscle tone, or posture), dystonia (abnormal muscle tone resulting in muscular spasm and abnormal posture), and gastrostomy (surgical creation of an opening into the stomach) status. During a telephone interview with Registered Nurse 1 (RN 1) on 6/9/2021, at 2:10 p.m., RN 1 stated she visited Patient 1 on 9/3/2019 for Patient 1's admission assessment at Patient 1's residence. RN 1 stated Patient 1 was observed to be "extremely thin." RN 1 stated she did not measure Patient 1's height and weight and Patient 1's height and weight were provided by the Certified Home Health Aide 1 (CHHA 1)/Patient 1's Family Member. On 6/10/2021, at 11:55 a.m., a telephone interview was conducted with RN 2, who was Patient 1's RN Case Manager and has been working out of the country remotely since April 2021. RN 2 stated she has not seen Patient 1 and she was not aware that Patient 1 was underweight. RN 2 stated she did not know Patient 1 was "extremely thin" because RN 1 did not tell her. RN 2 stated she did not communicate or collaborate with the physician and other agency's staff, including the Director of Patient Services (DPCS), for Patient 1's underweight issue. Patient 1's hospital record was reviewed. The "Physician Discharge Summary," dated 1/28/2020, indicated Patient 1 was admitted to the hospital on 1/16/2020 and discharged on 1/28/2020. Patient 1's diagnosis was severe malnutrition (when the body does not get enough nutrients). Patient 1's hospital record was reviewed. The "Pediatric Discharge Summary," dated 10/8/2020, indicated Patient 1 was admitted to the hospital on 9/17/2020 and discharged on 10/8/2020. The diagnoses were iron deficiency anemia (a condition of too little iron in the body) and severe malnutrition. Patient 1's hospital record was reviewed. The "Physician Discharge Summary," dated 12/29/2020, indicated Patient 1 was admitted to the hospital on 12/12/2020, with diagnosis of severe constipation leading to feeding intolerance and aspiration pneumonia (a lung infection caused by inhaled oral or gastric contents). Patient 1's record was reviewed. There was no communications or documented evidence that showed Patient 1's severe malnutrition issue and post hospitalization plan of care were discussed to further coordinate care for Patient 1. During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 2:20 p.m., the Administrator/DPCS stated patient's family, agency's employee, RN Case Manager, assistance case manager and/or supervisor are involved during case conference. During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 2:30 p.m., the Administrator/DPCS stated the staff should have collaborated for the care that Patient 1's needs. A review of the agency's undated policy and procedure titled, "Position Descriptions, RN Case Manager," indicated, " ... 5. Responsibilities (Case Managing & Supervising): ... i. Reports to the Director of Patient Care Services, other professional personnel, and physician (when appropriate) any changes in patient's signs/symptoms, physical status or major changes in care plan or referral to other services ... k. Supervises and Communicates to all members of the care team to improve the quality and condition of patient care, thereby assisting in the coordination of all services provided ..."

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the nursing staff teach the caregiver of the intramuscular injection (IM - the injection of a substance into a muscle), for one of seven sampled patients (Patient 3). This deficient practice placed a high risk for medication error and had a potential to result in Patient 3 did not receive the maximum effect of the medication. Findings: Patient 3's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 4/24/2021 to 6/22/2021, indicated the start of care (SOC) date for Patient 3 was 3/21/2016, with diagnoses which included disorders of lung and chromosomal abnormality (an error in cell division). The POC indicated Solu-Cortef (a medication used to treat various conditions; such as severe allergies, blood diseases, and breathing problems) 100 milligram (mg) one vial to be injected intramuscularly (IM - the injection of a substance into a muscle) if unable to tolerate oral dose. A home visit was conducted on 6/8/2021, at 11:35 a.m., for Patient 3. During an interview with Certified Home Health Aide 4 (CHHA 4)/Patient 3's Family Member on 6/8/2021, at 12:10 p.m., CHHA 4/Patient 3's Family Member stated she has injected Solu-cortef to Patient 3 when needed. CHHA 4/Patient 3's Family Member stated she received instruction of how to give IM injection from the doctor's office, not from the agency's staff. During an interview with Licensed Vocational Nurse 1 (LVN 1) on 6/11/2021, at 11:55 a.m., LVN 1 stated she could not find the documented evidence that the agency staff has provided education to CHHA 4/Patient 3's Family Member of IM injection. LVN 1 stated there was no documented evidence that the competentcy of CHHA 4/Patient 3's Family Member, specifically of IM injection, was checked. LVN 1 stated the agency's staff should have educated CHHA 4/Patient 3's Family Member regarding IM injection and verified the competency of CHHA 4/Patient 3's Family Member for IM injection. A review of the undated agency's policy and procedure titled, "Administering Medication & Profile," indicated " ... Nursing staff will assess on an ongoing basis the patient's response to the medication and the patient/caregiver's compliance with medication regimen ..."

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the quality assessment and performance improvement (QAPI) program included measurable data for improvement. This deficient practice had a potential to affect seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6 and Patient 7) and one unsampled patient (Patient 8) that inhibited to promote their health and safety. Findings: During a record review with the Administrator/Director of Patient Care Services (DPCS) on 6/10/2021, 4:10 p.m., the records titled, "Quality management Review/PAB, " dated from 6/2020 to 9/2020, from 10/2020 to 12/2020, and from 1/2021 to 3/2021 were reviewed. On the "Quality management Review/PAB" records, there were four topics on the forms. They were "Problems," "Person Responsible," "Improvements," and "Commendations." During a concurrent interview, the Administrator/DPCS stated the "Quality management Review/PAB" records were the quality assessment and performance improvement (QAPI meeting) records. The Administrator/DPCS stated the agency did not have QAPI records that include measurable improvement indicators.

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 ensure infection control practices were implemented, for one of seven sampled patients (Patient 2), when medical equipment were not disinfected (process of cleaning with the use of a chemical to kill germs). This failure had the potential to put patient, staff and family members for infection due to spreading of germs. Findings: During an observation on 6/8/2021, at 2:50 p.m., in Patient 2's home, Patient 2 had suction machine (medical device used for removing obstructions like mucus, saliva, blood, or secretions from a person's airway), oxygen tank, and nebulizer (medical device that turns liquid medicine into a mist to help treat breathing problems). During an interview with Certified Home Health Aide 3 (CHHA 3)/Patient 2's Family Member on 6/8/2021, at 2:50 p.m., CHHA 3/Patient 2's Family Member was asked how to clean and disinfect Patient 2's medical equipment. CHHA 3/Patient 2's Family Member stated, "We use paper towel." When asked if she use disinfecting wipes to disinfect Patient 2's medical equipment, CHHA 3/Patient 2's Family Member stated, "No." A review of the undated agency's policy and procedure titled, "Infection Control For Nursing Service," indicated, " ... i. All equipment and supplies will be cared for, disinfected and cleaned according to standards and procedures described in Infection Control Section ..." A review of the undated agency's policy and procedure titled, "Infection," indicated, " ...6. Handle Medical equipment and Instruments with Special Care: ... d. For disinfection, use the right chemicals at the proper strength ..."

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Skilled Professional Services as follows: 1. The HHA failed to evaluate the plan of care for one of seven sampled patients (Patient 2) in coordination with Patient 2's current health status and caregiver. (Refer to G 708). 2. The HHA failed to follow the plan of care for two of seven sampled patients (Patient 1 and Patient 2) when the fluid intake and urine output for Patient 1 was not monitored, and the neurological assessment at every visit was not completed for Patient 2. (Refer to G 710) 3. The HHA failed to ensure the nursing services were provided under the supervision of a Registered Nurse (RN) for three of seven sampled patients (Patient 1, Patient 3 and Patient 4) and one unsampled patient (Patient 8). (Refer to G 726) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the agency failed to evaluate the plan of care for one of seven sampled patients (Patient 2) in coordination with Patient 2's current health status and caregiver. This deficient practice had the potential for Patient 2's plan of care inaccurately reflect the patient's current health status. Findings: During an observation on 6/8/21, at 2 p.m., in Patient 2's home, Patient 2 was alert, oriented, and verbally responsive. Patient 2 was walking around, running, and playing with a cellphone. Patient 2 had a tracheostomy (opening created at the front of the neck so a tube can be inserted into the windpipe (trachea) to help with breathing) and was not connected to a ventilator (machine to blow air with extra oxygen into the airways and lungs). During an interview on 6/8/21, at 2 p.m., with Certified Home Health Aide 3 (CHHA 3)/Patient 2's Family Member, CHHA 3/Patient 2's Family Member stated Patient 2 is his son. CHHA 3/Patient 2's Family Member stated she is also his son's CHHA and is getting paid from the agency to take care of her son. CHHA 3/Patient 2's Family Member stated her son (Patient 2) is continent, able to use the restroom by himself, eats regular food diet by mouth, able to drink and does not use a ventilator. A review of Patient 2's "Home Health Certification and Plan of Care," dated 4/29/2021, indicated, "He [Patient 2] has a diagnosis of ventilator dependent and receives all nutrition via gastrostomy tube (a tube inserted through the belly that brings nutrition directly to the stomach)." During an interview on 6/8/2021, at 2:40 p.m., with Licensed Vocational Nurse 4 (LVN 4), LVN 4 stated, "I don't update the care plan, the agency should." LVN 4 stated she was not aware the care plan needed to be updated and revised. LVN 4 stated, "The care plan is old, we no longer do a lot of the ones listed." A review of the agency's undated policy and procedure (P&P) titled, "Plan of Care," indicated, "An individualized Plan of Care will be developed for each patient admitted and reviewed/revised as needed to meet the patient's needs."

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to follow the plan of care for two of seven sampled patients (Patient 1 and Patient 2) when: 1. Patient 1's fluid intake and urine output was not monitored as the physician ordered. 2. Licensed Vocational Nurse 4 (LVN 4) was not recording fluid intake and output for Patient 2 according to the plan of care. 3. LVN 4 was not performing neurological assessment for Patient 2 at every visit according to the plan of care. These deficient practices placed the patients at risk for not identifying signs of dehydration (occurs when the amount of water leaving the body is greater than the amount being taken in) and decline in the neurological (brain function) status. Findings: a) Patient 1's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 10/27/2020 to 12/25/2020, indicated the start of care (SOC) date for Patient 1 was 9/3/2019, with diagnoses which included cerebral palsy (a congenital disorder of movement, muscle tone, or posture), dystonia (abnormal muscle tone resulting in muscular spasm and abnormal posture), and gastrostomy (surgical creation of an opening into the stomach) status. A review of Patient 1's POC for the certification period from 10/27/2020 through 12/25/2020, included orders for the Registered Nurse Case Manager (RNCM) hours up to two hours and certified home health aide (CHHA) time 120-240 hours per month. Patient 1 had a 14 French gastrostomy tube (GT - a tube inserted through the belly that brings nutrition directly to the stomach) and received two cal HN (nutritional supplement) 5 cans per day via GT. The Registered Nurse Case Manager (RNCM) was to instruct the family on enteral nutrition and the care/use of equipment and to instruct the caregiver on proper care of tube and stoma. Patient 1 also had a physician's order to take Ensure (nutrional supplement) 8 ounces by mouth three times a day. A review of Patient 1's Outcome and Assessment Information Set (OASIS - The instrument/data collection tool used to collect and report assessment data by home health agencies), dated 9/3/2021, filled manually by Registered Nurse 1 (RN 1) indicated Patient 1's height was "5 inches" and the weight was 64 pounds. A review of Patient 1's Physician Order, dated 1/2/2020, indicated, "CHHA will document all intake and output for (Patient 1) and will report if (Patient 1) had no bowel movement (BM) and/or low urine output ..." A review of Patient 1's record indicated there was no documented evidence of Patient 1's fluid intake and urine output was monitored as the physician ordered. Patient 1's hospital record was reviewed. The "Physician Discharge Summary," dated 12/29/2020, indicated Patient 1 was admitted to the hospital on 12/12/2020, with diagnosis of severe constipation leading to feeding intolerance and aspiration pneumonia (a lung infection caused by inhaled oral or gastric contents). Patient 1's weight on admission was 29.5 Kilogram (65 pounds). During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 2:30 p.m., the Administrator/DPCS stated Patient 1's intake and output should have been monitored and documented as the physician ordered. When the policy for following the physician's order was requested, the agency provided the policy of Plan of Care. A review of the agency's undated policy on plan of care indicated the plan of care would serve as the physician's orders for patient care and all staff providing services would comply with the orders. A review of the agency's undated position descriptions of "RN Case Manager," indicated the RN case manager was to keep record of patient's food and fluid intake and output when ordered. b) A review of Patient 2's "Home Health Certification and Plan of Care" (POC) dated 4/29/2021, indicated, "He [Patient 1] has a medical diagnoses including congenital hypoventilation [disorder that affects normal breathing], tracheotomy [tracheostomy is an opening surgically created through the neck into the trachea (windpipe) to allow direct access to the breathing tube], ventilator [machine that blow air with extra oxygen into the airways and lungs) dependent, and receives all nutrition via gastrostomy [an opening into the stomach from the abdominal wall, made surgically for the introduction of food and medication] ..." During a review of Patient 2's POC, dated 4/29/2021, the POC indicated, "LVN/HHA [Licensed Vocational Nurse/Home Health Aide] to assist with incontinent care as needed and to document intake and output every shift." During an interview on 6/8/2021, at 2 p.m., with Certified Home Health Aide 3 (CHHA 3)/Patient 2's Family Member, CHHA 3/Patient 2's Family Member stated Patient 2 is his son. CHHA 3/Patient 2's Family Member stated she is also his son's CHHA and is getting paid to take care of her son. CHHA 3/Patient 2's Family Member stated, "He [Patient 2] is continent and able to use the restroom by himself." During an interview on 6/8/2021, at 2:40 p.m., with LVN 4, LVN 4 stated, "I don't record his I&O [input and output], he drinks well. I don't offer him [Patient 2] to use the restroom every two hours, he is continent." c) During a review of Patient 2's POC, dated 4/29/2021, the POC indicated, "LVN to perform a neurological assessment each visit." During an interview on 6/8/2021, at 2:40 p.m., LVN 4 stated, "I don't do neurological assessment each visit, there's no need for that, he [Patient 2] is very alert." During a review of the undated agency's policy and procedure (P&P) titled, "Plan of Care," indicated, "The Plan of Care will serve as a physician's orders for patient care and all staff providing services will be in compliance with the orders."

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health agency (HHA) failed to ensure the nursing services were provided under the supervision of a registered nurse (RN) for three of seven sampled patients (Patient 1, Patient 3 and Patient 4) and one unsampled patient (Patient 8) by failing to: 1. Clarify the order for frequency of Hydrocortisone (a medicine that is used in the treatment of many different conditions), medication with the physician and update the medication profile for Patient 3; 2. Perform comprehensive assessment for discharge planning for Patient 1 and Patient 8; and 3. Ensure the RN supervised Patient 4's nursing care as indicated in the patient's plan of care. These deficient practices placed Patient 4 at risk for inadequate care due to lack of RN supervision, had the potential for Patient 3 to receive a medication with an inaccurate frequency for administering the medication, and Patient 1 and Patient 8 to be discharged from the agency with incomplete discharge instruction and preparation. Findings: a) A review of Patient 3's "Home Health Certification and Plan of Care" (POC), certification period from 4/24/2021 to 6/22/2021, indicated the start of care (SOC) date for Patient 3 was 3/21/2016, with diagnoses including disorders of lung and chromosomal abnormality (an error in cell division). A review of Patient 3's POC indicated a physician's order for medications including Hydrocortisone 5 milligram (unit of measurement) 1/4 tablet, to be given in the morning, midday, and evening if fever was greater than 100.4 Fahrenheit (F), or if vomiting, or diarrhea occurred. During a home visit on 6/8/2021, at 11:35 a.m., Patient 3 was observed sitting on the floor and Certified Home Health Aide 4 (CHHA 4)/Patient 3's Family Member was preparing lunch for Patient 3. On 6/8/2021, at 12:05 p.m., Patient 3's medications were reviewed with CHHA 4/Patient 3's Family Member by comparing Patient 3's POC with the Patient 3's medication profile. CHHA 4/Patient 3's Family Member stated Hydrocortisone 5 milligram 1/4 tablet had been administered to the patient twice (not three times a day), in the morning and in the evening since 3/7/2021. A review of Patient 3's medication profile, dated 5/17/2021, indicated Patient 3 was to take Hydrocortisone 5 milligram 1/4 tablet in the morning, midday, and evening if fever was greater than 100.4 Fahrenheit (F), or if vomiting, or diarrhea occurred. A review of Patient 3's record indicated there was no documented evidence the agency's licensed nurse had clarified with the physician and updated the medication profile. On 6/11/2021, during an interview with the Administrator/Director of Patient Care Service (DPCS), he stated Patient 3's medication profile should have been updated after clarifying with the patient's physician. A review of the undated agency's policy titled, "Medication Regimen Review," indicated the review of medications will be on-going but done a minimum of every 60 days. b) A review of Patient 1's record indicated a start of care (SOC) dated 9/3/2019, with diagnoses which included cerebral palsy (disorder that affect a person's ability to move and maintain balance and posture), dystonia (abnormal muscle tone resulting in muscular spasm and abnormal posture), and gastrostomy (surgical creation of an opening into the stomach for food, medicines, and/or drainage) status. A review of Patient 1's "Home Health Certification and Plan of Care" (POC) for the certification period from 10/27/2020 through 12/25/2020, included an order for the Registered Nurse Case Manager (RNCM) hours up to 2 hours and certified home health aide (CHHA) time 120-240 hours per month. A reivew of Patient 1's physician's order, dated 12/16/2020, indicated Patient 1 will be discharged from all services rendered by the agency due to Service Authorization Request (SAR) being denied by the California Children's Service (CCS). A review Patient 1's Skilled Nurse (SN) Discharge Summary, dated 12/16/2020, signed by Licensed Vocational Nurse 1 (LVN 1) indicated due to SAR being denied by the California Children's Service (CCS), the case was discharged. A review of the "Physician Discharge Summary" of Acute Hospital 1, dated 12/29/2020 indicated Patient 1 was admitted to Acute Hospital 1 on 12/12/2020 with diagnosis of severe constipation leading to feeding intolerance and aspiration pneumonia (a lung infection caused by inhaled oral or gastric contents). Patient 1's weight on the admission was 29.5 Kg (65 pounds). A review of the "Discharge OASIS" (OASIS - Outcome and Assessment Information Set, is the instrument/data collection tool used to collect and report assessment data by home health agencies), dated 12/16/2021, electronically signed by LVN 1, indicated the space of "Condition at Discharge" was blank. There was no indication that Patient 1 had been admitted to Acute hospital 1. During an interview with LVN 1 on 6/10/2021, at 4:45 p.m., LVN 1 stated she just input the data in the "Discharge OASIS" based on the RN's most current assessment from the last visit and communication with the family. A review of Patient 1's record indicated there was no documented evidence the comprehensive discharge assessment and discharge planning was performed by the RN or cosigned by an RN. During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 3:05 p.m., the Administrator/DPCS was not able to provide the documented evidence of comprehensive discharge assessment and discharge planning was performed by the RN or cosigned by an RN. The Administrator/DPCS stated the RN should have performed comprehensive assessment and discharge planning for Patient 1. A review of the undated agency's position description titled, "RN Case Manager," indicated the RN case manager was to "write discharge summary upon discontinuance of service care, condition on discharge, and to whom discharged." c) A review of Patient 8's "Home Health Certification and Plan of Care" (POC), for the certification period from 11/6/2020 to 1/4/2021, indicated a start of care date (SOC) of 3/11/2020, with diagnosis of cerebral palsy (a group of disorders that affect a person's ability to move and maintain balance and posture). A review of Patient 8's POC further indicated an order for Registered Nurse Case Manager (RNCM) up to two hours per month, Licensed Vocational Nurse (LVN) 30 - 60 hours per month and Certified Home Health Aid (CHHA) 90-180 hours per month. A review of Patient 8's Physician Order, dated 4/29/2021, indicated that Patient 8 had been discharged from the agency. A review of Patient 8's Outcome and Assessment Information Set (OASIS - The instrument/data collection tool used to collect and report assessment data by home health agencies), dated 4/29/2021, indicated the OASIS was electronically signed by Licensed Vocational Nurse 2 (LVN 2). The OASIS had no signature by a Registered Nurse (RN) and no indication that an RN had performed the discharge OASIS. During an interview with Licensed Vocational Nurse 2 (LVN 2) on 6/10/2021, at 4:35 p.m., she stated that the discharge OASIS is inputted into the computer by the LVN based on the RN assessment. LVN 2 further stated that the discharge OASIS was electronically signed by the LVN who inputted the information into the system and there was no co-signature by the RN. During an interview with the Administrator/DPCS on 6/11/2021, at 2:20 p.m., he stated that the comprehensive assessments were done by the RN only. A review of the undated agency's position description titled, "RN Case Manager," indicated that the responsibilities include writing discharge summary upon discontinuance of service care, condition of discharge, and to whom discharged. d) A review of Patient 4's "Home Health Certification and Plan of Care" (POC), for the certification period from 5/13/2021 to 7/11/2021, indicated a start of care date (SOC) of 7/23/2019, with diagnosis of epilepsy (disorder in which brain activity becomes abnormal, causing seizures or periods of unusual behavior, sensations, and sometimes loss of awareness). A review of Patient 4's Plan of Care further indicated an order for Registered Nurse Case Manager (RNCM) up to two hours per month and a Registered Nurse (RN) 100 - 200 hours per month. Patient 4 had a home visit on 6/8/2021 at 12 p.m.,During an interview on 6/8/2021 at 12 p.m. with Patient 4's family member or legal representative (Family Member 9 [FM 9]), he stated Patient 4's caregiver (Physician 1 [PHY 1]/Patient 4's Family Member) is a Pediatrician (a medical practitioner specializing in children and their diseases). During an interview with the PHY 1/Patient 4's Family Member on 6/8/2021 at 12:10 p.m., when asked about what kind of supervision does she get from the HHA, she stated "because I am already an MD (medical doctor), they (she meant the HHA) got permission for me to do it, supervision from the HHA is not necessary." During a concurrent interview with FM 9, FM 9 stated, "no supervisory visits, but she (meant PHY 1/Patient 4's Family Member) supervises herself." During another interview on 6/8/2021, at 12:30 p.m., with FM 9, FM 9 stated, "she (meant PHY 1/Patient 4's Family Member) is an MD (medical doctor), she is more than an RN/LVN (Registered Nurse/Licensed Vocational Nurse) herself." During an interview with the Administrator/DPCS on 6/11/2021, at 2:20 p.m., he stated that PHY 1/Patient 4's Family Member has a Medical Doctor (MD) license and hired by the agency as an RN Field Nurse to perform RN services and PHY 1/Patient 4's Family Member does not have an RN license. A review of Patient 4's hand written Supervisory Visit notes, dated 4/15/2021 and 5/20/2021, indicated that PHY 1/Patient 4's Family Member had written her name on the section "Name of RN". A review of the Patient 4's caregiver's (PHY 1/Patient 4's Family Member) license indicated her license type as: "Physician and Surgeon A." A review of the HHA's policy titled, "RN/LVN Services Supervision," indicated the RNCM or RN Supervisor will conduct supervisory visits on the RN shift case per month or PRN (pro re nata, as needed). This will be documented accordingly and remain a part of the clinical record. A review of the HHA's policy titled, "Nurse Supervisor," indicated, "Provides direct supervision of all direct patient services personnel. Coordinates care services ... Responsibilities: a. Supervises and directs nursing and home health care in conformance to services prescribed by the attending physician. Reviews all plans of treatment for accuracy, appropriateness and completeness ... f. Supervises and trains other RN, LVN and CHHA nursing service personnel .... N. Follows up with Staff Nurses to assure that monthly case conferences are done on each patient, recorded and filed in patient's chart ...." A review of HHA's undated policy titled, "Director of Patient Care Services," indicated, "Job Description: Provides overall planning, direction, coordination, management of all nursing and professional therapy services in conjunction with the Administrator. Assures quality and adequacy of patient care by reviewing and assessing each service. Shall also hold responsibility for the development of personnel qualifications and assignments .... 5. Responsibilities and Duties: f. Reviews qualifications and job descriptions for employees rendering services to patients."

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Home Health Aide Services as follows: 1. The HHA failed to ensure a qualified certified home health aide (CHHA) was providing services for one of seven sampled patients (Patient 1). (Refer to G 754) 2. The HHA failed to ensure a Registered Nurse (RN) provided written patient care instruction to the certified home health aide (CHHA) for three of seven sampled patients (Patient 1, Patient 2 and Patient 3) and one unsampled patient (Patient 8). (Refer to G 798) 3. The HHA failed to ensure Registered Nurse (RN) supervisory onsite visit to certificed home health aides (CHHA) was conducted every 14 days for two of seven sampled patients (Patient 2 and Patient 3). (Refer to G 808) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

A qualified HH aide successfully completed: CFR(s): 484.80(a)(1)(i-iv) A qualified home health aide is a person who has successfully completed: (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure a qualified certified home health aide (CHHA) was providing services for one of seven sampled patients (Patient 1). This deficient practice placed the patient at risk for not receiving quality home care. Findings: A review of Patient 1's "Home Health Certification and Plan of Care" (POC), for the certification period from 3/1/2020 to 4/29/2020 and from 4/30/2020 to 6/28/2020, indicated a start of care date (SOC) of 9/3/2019, with a diagnosis of cerebral palsy (disorders that affect a person's ability to move and maintain balance and posture). A review of Patient 1's Plan of Care indicated an order for Registered Nurse Case Manager (RNCM) up to two hours per month and Certified Home Health Aide (CHHA) 120 - 240 hours per month. A review of Patient 1's aide notes, indicated Patient 1's family member 1 was documenting services from 3/1/2020 to 5/17/2020, during the time that the Plan of Care had orders for CHHA services. A review of employee record of Certified Home Health Aide 1 (CHHA 1)/Patient 1's Family Member indicated that she was issued her CHHA certificate on 5/18/2020. During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 2:20 p.m., he stated that CHHA 1/Patient 1's Family Member did not have a CHHA certificate during the period of 3/1/2020 to 5/17/2020 and CHHA 1/Patient 1's Family Member worked as a caregiver/personal care service (PCS) during that time (3/1/2020 to 5/17/2020). A review of the agency's policy and procedure titled, "Home Health Aide," revised 5/1/02, indicated that a Home Health Aide shall be certified by the State and is in a good standing. The policy and procedure indicated that the home health aide shall have at least one year of home health care experience.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency failed to ensure a Registered Nurse (RN) provided written patient care instruction to the certified home health aide (CHHA) for three of seven sampled patients (Patient 1, Patient 2 and Patient 3) and one unsampled patient (Patient 8). This deficient practice had the potential to prevent the HHA in providing quality home care that the patient might need. Findings: a) A review of Patient 1's record indicated a start of care (SOC) dated 9/3/2019, with diagnoses which included cerebral palsy (disorder that affect a person's ability to move and maintain balance and posture), dystonia (abnormal muscle tone resulting in muscular spasm and abnormal posture), and gastrostomy (surgical creation of an opening into the stomach for food, medicines, and/or drainage) status. A review of Patient 1's "Home Health Certification and Plan of Care" (POC), for the certification period from 10/27/2020 through 12/25/2020, included orders for the Registered Nurse Case Manager (RNCM) hours up to 2 hours and certified home health aide (CHHA) time 120-240 hours per month. A review of the Home Health Aide Care Plan, electronically signed by Licensed Vocational Nurse 1 (LVN 1) from 1/31/2020 to 11/27/2020, indicated the CHHA was to assess the vital signs including temperature, blood pressure, heart rate, and respiration at every visit. However, there was no instruction indicated when the CHHA was to notify the agency or the physician for the out-of-range parameter of vital signs. A review of Patient 1's record indicated there was no documented evidence the CHHA Care Plan was written by the RN or co-signed by RN. b) A review of Patient 2's record indicated a start of care (SOC) dated 8/13/2014, with diagnoses which included congenital central alveolar hypoventilation syndrome (disorder that affects normal breathing), tracheostomy status (opening created at the front of the neck so a tube can be inserted into the windpipe (trachea) to help with breathing), and gastrostomy (a surgical creation of an opening into the stomach for food, medicines, and/or drainage) status. A review of Patient 2's "Home Health Certification and Plan of Care" (POC), for the certification period from 4/30/2021 to 6/28/2021, included order for the Registered Nurse Case Manager (RNCM) hours up to 2 hours, Licensed Vocational Nurse hours 90-180 hours per month, and certified home health aide (CHHA) hours 120-240 hours per month. A review of Patient 2's record indicated there was no documented evidence the CHHA Care Plan was written by the RN or co-signed by RN. c) A review of Patient 3's record indicated a start of care (SOC) dated 3/21/2016, with diagnoses which included disorders of lung and chromosomal abnormality (an error in cell division). A review of Patient 3's "Home Health Certification and Plan of Care" (POC), for the certification period from 4/24/2021 to 6/22/2021, included order for the Registered Nurse Case Manager (RNCM) hours up to 2 hours, Licensed Vocational Nurse hours 60-120 hours per month, and certified home health aide (CHHA) hours 60-120 hours per month. A review of Patient 3's clinical record indicated there was no documented evidence the HHA Care plan was written by the RN or co-signed by RN, except on 1/17/2021 and 3/22/2021. On 6/11/2021, at 3:05 p.m., during an interview with the Administrator/DPCS, he was not able to provide the documented evidence that the RN provided CHHA care plan or co-signed in CHHA Care Plans for Patient 1, Patient 2 and Patient 3, and stated the RN should have provided CHHA written instruction. A review of the agency's undated position descriptions of "Nurse Supervisor" indicated the qualifications of nurse supervisor was the registered professional nurse. The responsibilities included to direct nursing and home health care and to provide written instructions for the patient care. d) A review of Patient 8's "Home Health Certification and Plan of Care" (POC), for the certification period from 11/6/2020 to 1/4/2021, indicated a start of care date (SOC) of 3/11/2020, with diagnosis of cerebral palsy (a group of disorders that affect a person's ability to move and maintain balance and posture). A review of Patient 8's POC indicated an order for Registered Nurse Case Manager (RNCM) up to two hours per month, Licensed Vocational Nurse (LVN) 30 - 60 hours per month, and Certified Home Health Aide (CHHA) 90-180 hours per month. A review of Patient 8's CHHA Care Plan, dated 10/25/2020, indicated Licensed Vocational Nurse 2 (LVN 2) had electronically signed the CHHA Care Plan. The CHHA Care Plan had no signature by a Registered Nurse (RN) and no indication that an RN had prepared the care plan. During an interview with Licensed Vocational Nurse 2 (LVN 2) on 6/10/2021, at 4:35 p.m., she stated the CHHA Care Plan was created for Patient 8 based on the verbal report from the RN and that it was inputted into the system by an LVN. LVN 2 further stated that the CHHA Care Plan was electronically signed by the LVN who inputted the information into the system and there was no co-signature by the RN. A review of the undated agency's policy and procedure titled,"Aide Instruction Sheet/Plan of Services," indicated that the agency would ensure proper supervision and orientation of the home health aide by means of instruction sheet. The policy and procedure further indicated that the written instructions for the patient care are prepared by the registered nurse or therapist on the aide care plan/assignment sheet.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech-language pathology services, a registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in §484.80(g), must make an onsite visit to the patient's home no less frequently than every 14 days. The home health aide does not have to be present during this visit. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure Registered Nurse (RN) supervisory onsite visit to certificed home health aides (CHHA) was conducted every 14 days for two of seven sampled patients (Patient 2 and Patient 3). This deficient practice resulted in lack of RN oversight and had the potential to result in care and services not being provided to the patients. Findings: a) During a review of Patient 2's "Home Health Certification and Plan of Care" (POC), dated 4/29/21, the POC indicated, "Frequency of Visits: RNCM (Registered Nurse Case Manager) 2 hours per month." During an interview on 6/8/2021, at 2 p.m., with Certified Home Health Aide 3 (CHHA 3)/Patient 2's Family Member, CHHA 3/Patient 2's Family Member stated, "The RN used to come and visit every month before the COVID-19 pandemic. But during the pandemic, we do FaceTime with the RN once a month." During a review of the undated agency's policy and procedure titled, "Home Health Aide/Personal Care Services Supervision," indicated, "If the patient receives skilled nursing care, the registered nurse/vocational nurse shall perform supervisory visit every 2 weeks." b) A review of Patient 2's record indicated a start of care (SOC) dated 8/13/2014, with diagnoses which included congenital central alveolar hypoventilation syndrome (disorder that affects normal breathing), tracheostomy status (an opening surgically created through the neck into the trachea (windpipe) to allow direct access to the breathing tube), and gastrostomy (surgical creation of an opening into the stomach for food, medicines, and/or drainage) status. A review of Patient 2's "Home Health Certification and Plan of Care" (POC), for the certification period from 4/30/2021 to 6/28/2021, included order for the Registered Nurse Case Manager (RNCM) hours up to 2 hours, Licensed Vocational Nurse hours 90-180 hours per month, and certified home health aide (CHHA) hours 120-240 hours per month. A review of Patient 2's record indicated there were monthly Home Health Aide supervisory visit notes dated 6/11/2020, 7/10/2020, 8/11/2020, 9/10/2020, 10/13/2020, 11/3/2020, 12/30/2020, 1/7/2021, 2/9/2021, and 3/9/2021. c) A review of Patient 3's record indicated a start of care (SOC) dated 3/21/2016, with diagnoses which included disorders of lung and chromosomal abnormality. A review of Patient 3's "Home Health Certification and Plan of Care" (POC), for the certification period from 4/24/2021 to 6/22/2021, included order for the Registered Nurse Case Manager (RNCM) hours up to 2 hours, Licensed Vocational Nurse hours 60-120 hours per month, and certified home health aide (CHHA) hours 60-120 hours per month. A review of Patient 3's record indicated there were monthly Home Health Aide supervisory visit notes dated 6/16/2020, 7/30/2020, 8/29/2020, 9/26/2020, 10/19/2020, 11/13/2020, 12/19/2020, 1/17/2021, 2/22/2021, and 3/22/2021. On 4/6/2021, at 1 p.m., during a telephone interview with the Administrator/Director of Patient Care Service (DPCS), he stated the home health aide supervisory visit was to be done every month. The Administrator/DPCS was not aware the HHA supervisory visit should have been done every two weeks, not every month for Patient 2 and Patient 3. A follow up interview was conducted with the Administrator/DPCS on 6/11/2021, at 3:15 p.m., he stated the HHA supervisory visit should have been done every 14 days. A review of the undated agency's policy and procedure titled, "Home Health Aide Personal Care Services Supervision" indicated if the patient receive skilled nursing care, the registered nurse/vocational nurse shall perform the supervisory visit every 2 weeks. A review of the undated agency's policy and procedure titled, "The Patient Record (under supervisory visit)," indicated the Home Health Aide supervisory visits shall be documented and underlined every two weeks.

Compliance with Federal, State, Local Law CFR(s): 484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients. The HHA and its staff must operate and furnish services in compliance with all applicable federal, state, and local laws and regulations related to the health and safety of patients. If state or local law provides licensing of HHAs, the HHA must be licensed. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Compliance with Federal, State, and Local Law as follows: 1. The HHA failed to ensure the staff providing services to the patients were licensed, certified, or registered in accordance with state licensing authority as meeting those requirements for four of nine sampled staff members (RN 3, RN 5, LVN 3 and PHY 1) and for two of seven sampled patients (Patient 4 and 7). (Refer to G 860) 2. The HHA failed to ensure that the Administrator Designee met the required qualifications. (Refer to G 954) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

Licensing CFR(s): 484.100(b) (b) Standard: Licensing. The HHA, its branches, and all persons furnishing services to patients must be licensed, certified, or registered, as applicable, in accordance with the state licensing authority as meeting those requirements. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the Home Health agency (HHA) failed to ensure the staff providing services to the patients were licensed, certified, or registered in accordance with state licensing authority as meeting those requirements for four of nine sampled staff members (RN 3, RN 5, LVN 3 and PHY 1) and for two of seven sampled patients (Patient 4 and 7). This deficient practice resulted in the agency hiring the staff that did not comply with the State Licensing Requirements for Home Health Agencies (HHA). Findings: a) A review of Patient 7's Plan of Care for the certification period of 4/22/2021 - 6/20/2021 indicated a start of care date (SOC) of 10/30/2019, with diagnosis of spastic quadriplegic cerebral palsy (loss of use of the whole body). A review of Patient 7's Plan of Care further indicated an order for Registered Nurse Case Manager (RNCM) up to two hours per month and Licensed Vocational Nurse (LVN) 90 - 180 hours per month. A review of Patient 7's Skilled Nursing Visit Notes from 4/22/2021 to 6/5/2021 indicated Registered Nurse 3 (RN 3)/Patient 7's Family Member documented her name in the section "Nurse Name" and in the section "Nurse Initial/Title" she documented her initials and entered RN as the title. Further review of Patient 7's Skilled Nursing Visit Notes indicated that there was no notes by an LVN. A review of RN 3/Patient 7's Family Member's employee record indicated that she was hired as a Field RN. A review of the RN 3/Patient 7's Family Member's employee record indicated that RN 3/Patient 7's Family Member has a Registered Nurse's license and not a license for a Licensed Vocational Nurse (LVN). During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 2:20 p.m., he stated that RN 3/Patient 7's Family Member is an RN providing LVN services for Patient 7. A review of the California Code of Regulations Tittle 22, Article 1, § 74631 Licensed Vocational Nurse indicates that a Licensed Vocational Nurse means a person licensed as a licensed vocational nurse by the Board of Vocational Nursing and Psychiatric Technicians. b) A review of RN 5's employee record indicated that she was hired at the agency on 4/26/2019 as a Field Nurse and was issued her Registered Nurse license on 8/23/2018. During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 2:20 p.m., he stated that RN experience on hire is based on individual basis and no experience is needed. A review of the California Code of Regulations Tittle 22, Article 3, § 74707(c) Skilled Nursing Services indicates that a effective 1/1/1998, registered nurses providing services in a patient's temporary or permanent place of residence through a home health agency shall have one year prior professional nursing experience. c) A review of LVN 3/Patient 6's Family Member's employee record indicated that he was hired at the agency on 10/12/2020 as a Licensed Vocational Nurse (LVN) and was issued his Licensed Vocational Nurse license on 7/1/2020. During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 2:20 p.m., he stated that there is no LVN experience required to work at the home health agency. A review of the California Code of Regulations Tittle 22, Article 3, § 74707(d) Skilled Nursing Services indicates that a effective 1/1/1998, licensed vocational nurses providing services in a patient's temporary or permanent place of residence through a home health agency shall have one year prior professional nursing experience. d) A review of Patient 4's "Home Health Certification and Plan of Care" (POC), for the certification period from 5/13/2021 to 7/11/2021, indicated a start of care date (SOC) of 7/23/2019, with diagnosis of epilepsy (disorder in which brain activity becomes abnormal, causing seizures or periods of unusual behavior, sensations, and sometimes loss of awareness). A review of Patient 4's Plan of Care further indicated an order for Registered Nurse Case Manager (RNCM) up to two hours per month and a Registered Nurse (RN) 100 - 200 hours per month. Patient 4 had a home visit on 6/8/2021 at 12 p.m. During an interview on 6/8/2021, at 12 p.m., with Patient 4's family member/legal representative (FM 9) he stated, Patient 4's caregiver (Physician 1 [PHY 1]/Patient 4's Family Member) is a Pediatrician (a medical practitioner specializing in children and their diseases). During an interview with Patient 4's caregiver (PHY 1/Patient 4's Family Member) on 6/8/2021, at 12:30 p.m., she stated, she sends the "case conference notes, supervisory notes, daily notes, 30-day notes and 60-day notes plus her timesheet" to the HHA weekly. During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 2:20 p.m., he stated that PHY 1/Patient 4's Family Member has a Medical Doctor (MD) license and hired by the agency as an RN Field Nurse to perform RN services and she does not have an RN license. A review of Patient 4's Skilled Nursing Visit Notes from 5/13/2021 to 6/5/2021 indicated PHY 1/Patient 4's Family Member documented her name in the section "Nurse Name" and in the section "Nurse Initial/Title" she documented her initials and entered RN as title. A review of the caregiver's (PHY 1/Patient 4's Family Member) license indicated her license type: "Physician and Surgeon A". A review of the HHA's undated policy titled, "Field RN Job Description and Duties," indicated, "Policy: (Agency's name) shall provide skilled nursing services by a Registered Nurse under the supervision of the Director of Nursing according to the standards of Nursing Care ... Qualifications: A graduate of an accredited school of Registered Nursing with current license ... Must adhere to the Board of Registered Nursing Examinations rules and regulations, be in and remain in good standing with the board ..." A review of California Code of Regulations Title 22, Article 1, §74651 Registered Nurse, indicated "Registered Nurse" means a person licensed in the State of California by the Board of Registered Nursing. A review of California Code of Regulations Title 22, Article 1, §74652 Skilled Nursing Services Criteria for Licensure of Home Health Agencies, indicated (a) for purposes of licensure as a home health agency, "skilled nursing services" means services which are provided by and within the scope of practice of a registered nurse or licensed vocational nurse.

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health agency (HHA) failed to ensure that the Administrator Designee met the required qualifications. This deficient practice resulted in the agency hiring an Administrator Designee that did not meet the qualifications. Findings: A review of the Administrator Designee's employee record indicated that she was appointed the role in 12/21/2019, and had a high school diploma. During an interview with the Administrator Designee on 6/11/2021, at 2:20 p.m., she stated that she has a high school diploma and is currently in the process of getting her Bachelor's degree. A review of the undated agency's position description titled, "Administrator/Director of Operations," does not indicate that the Administrator needs to have an undergraduate degree. The position description instead indicated that qualifications include a Bachelor's Degree or a health related license in the State of California or two years minimum experience in supervision or administration in a home health agency or related program in California within the last six years.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Clinical records by failing, for two of seven sampled patients (Patient 1 and Patient 3), to ensure comprehensive assessment in the records reflected the patients' health status. (Refer to G 1012) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed, for two of seven sampled patients (Patient 1 and Patient 3), to ensure comprehensive assessment in the records reflected the patients' health status. This deficient practice resulted in Patient 1 admitted to the general acute care hospital due to severe malnutrition and has a potential to result in delaying to provide care that meet the patients' needs. Findings: a) Patient 1's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 10/27/2020 to 12/25/2020, indicated the start of care (SOC) date for Patient 1 was 9/3/2019, with diagnoses which included cerebral palsy (a congenital disorder of movement, muscle tone, or posture), dystonia (abnormal muscle tone resulting in muscular spasm and abnormal posture), and gastrostomy (surgical creation of an opening into the stomach) status. A review of Patient 1's Outcome and Assessment Information Set (OASIS - The instrument/data collection tool used to collect and report assessment data by home health agencies), dated 9/3/2019, from 3 p.m. to 4 p.m., electronically completed and signed by Registered Nurse 2 (RN 2) indicated there were no vital signs, no height, and weight in the OASIS. The "Seziure precaution" and "Unable to take nutrition orally" were checked. A review of another set of OASIS for Patient 1, with the same date of 9/3/2019, from 4:45 p.m. to 5:45 p.m., manually completed and signed by Registered Nurse 1 (RN 1), indicated there were no vital signs recorded in the OASIS. The height for Patient 1 was documented as "5 inches" and the weight was 64 pounds. The "Seziure precaution" and "Unable to take nutrition orally" were not checked. A further review of the OASISs completed by RN 1 and RN 2 indicated the followings: - "Productive cough": RN 1 checked the box while RN 2 did not check the box. - "Limited range of montion 'ROM'": RN 1 did not check the box while RN 2 checked the box and documented for both upper and lower extremities. - "High risk for fall": RN 1 did not check the box while RN 2 checked the box. - "Fall risk Assessment": RN 1 did not check the box while RN 2 documented the patient scored was 5 (A score of 4 or more is considered at risk for fall). - "Ambulation /Locomotion": RN 1 checked on bedfast while RN 2 checked chairfast. - RN 1 checked "caregiver demonstrate necessary skills aid patient in managing disease process while RN 2 did not check this box. During a telephone interview with RN 2 on 6/10/2021, at 11:55 a.m., RN 2 stated she was Patient 1's RN case manager and she has been working out of the country remotely since April 2021. RN 2 stated she completed Patient 1's OASIS electronically by using RN 1's OASIS information and follow-up call with Patient 1's family. During a telephone interview with RN 1on 6/9/2021, at 2:10 p.m., RN 1 stated she did not measure Patient 1's height and weight. RN 1 stated she was told by Patient 1's Certified Home Health Aide 1 (CHHA 1)/Patient 1's Family Member of Patient 1's height and weight, and recorded them in the OASIS. RN 1 stated she did not document the vital signs in the OASIS. A review of the CHHA notes, dated from 1/12/2020 to 1/16/2020, was conducted. There were no documented evidence that Patient 1' vital signs readings, nutritional status, and intake and output for Patient 1 were recorded on the notes. Patient 1's hospital record was reviewed. The "Physician Discharge Summary," dated 1/28/2020, indicated Patient 1 was admitted to the hospital on 1/16/2020 and discharged on 1/28/2020. Patient 1's diagnosis was severe malnutrition. A review of the CHHA notes, dated from 9/13/2020 to 9/16/2020, was conducted. There were no documented evidence that Patient 1' vital signs readings, nutritional status, and intake and output for Patient 1 were recorded on the notes. Patient 1's hospital record was reviewed. The "Pediatric Discharge Summary," dated 10/8/2020, indicated Patient 1 was admitted to the hospital on 9/17/2020 and discharged on 10/8/2020. The diagnoses were iron deficiency anemia (a condition of too little iron in the body) and severe malnutrition. It was indicated Patient 1's weight on the admission was 25.7 kilogram (kg) (56 pounds and 10.5 ounce). A review of the CHHA notes, dated from 12/6/2020 to 12/11/2020, was conducted. There was no documented evidence that Patient 1' vital signs readings, nutritional status, and intake and output for Patient 1 were recorded on the notes. Patient 1's hospital record was reviewed. The "Physician Discharge Summary," dated 12/29/2020, indicated Patient 1 was admitted to the hospital on 12/12/2020, with diagnosis of severe constipation leading to feeding intolerance and aspiration pneumonia (a lung infection caused by inhaled oral or gastric contents). During a telephone interview with Patient 1's CHHA 1/Patient 1's Family Member on 6/9/2021, at 2:20 p.m., CHHA 1/Patient 1's Family Member stated Patient 1's weight was not assessed by the HHA's staff from admission (9/3/2019) to discharge (12/16/2020). A review of the Discharge OASIS, dated 12/16/2020, electronically signed by Licensed Vocational Nurse 1 (LVN 1), indicated there were no documentation for Patient 1's vital signs and condition at discharge. During an interview and a concurrent record review with LVN 1 on 6/10/2021, at 12:40 p.m., LVN 1 stated she was not able to find the documented evidence in Patient 1's record that a comprehensive assessment was performed for Patient 1. There were total two "Start of Care" OASISs found in Patient 1's record. Beside the "Start of Care" OASISs, there was no documentation indicated comprehensive assessment was conducted on Patient 1 from 10/27/2020 to 12/16/2020. b. Patient 3's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), certification period from 4/24/2021 to 6/22/2021, indicated the start of care (SOC) date for Patient 3 was 3/21/2016, with diagnoses which included disorders of lung and chromosomal abnormality (an error in cell division). A review of Patient 3's OASIS, dated 3/21/2016, indicated there were no vital signs documented. The space for vital signs and the space for vital signs parameter were blank. The space for height and weight was also blank. During a home visit conducted on 6/8/2021, at 11:35 a.m., Patient 3 was observed sitting on the floor and CHHA 4/Patient 3's Family Member was preparing lunch for Patient 3. During an interview with CHHA 4/Patient 3's Family Member on 6/8/2021, at 12 p.m., CHHA 4/Patient 3's Family Member stated the HHA's staff did not assess Patient 3's height and weight; however, the HHA's staff had asked her for Patient 3's height and weight. CHHA 4/Patient 3's Family Member stated she did not even have a scale at home, and the HHA did not worry about Patient 3's weight. During an interview with the Administrator/Director of Patient Care Services (DPCS) on 6/11/2021, at 2:30 p.m., the Administrator/DPCS stated vital signs and weight should be assessed upon admission with parameters. The Administrator/DPCS further stated that the intake and output of patients should have been checked and documented as ordered. A review of the agency's undated policy and procedure titled, "The Patient Record, 15. Comprehensive Assessment," indicated, " ... On initial and recertification, (agency's name) will use the OASIS form (see attached) for documentation purposes only not for transmittal." A review of the agency's undated policy titled, "RN Case Manager," indicated to obtain a complete health history and perform head to toe physical exam upon admission. A review of the agency's undated policy titled, "Vital Signs," indicated the vital signs shall be taken on admission, every visit/shift, and more frequently as dicated by the physician order and condition of the patient. A review of the agency's undated policy and procedure titled, "Documentation/Electronic Signatures," indicated, " ... Any/all changes to time-sensitive electronic clinical documentation will only be performed with the author's expressed permission by authorized Coders/Coordinators/Managers within the Agency for quality/regulatory compliance, and will be manually co-signed/dated by said Coder/Coordinator/Manager. When feasible, ..., electronic submitted notes/documentation will be sent back to the author for review/revision.