Every finding on record at Visiting Home Nurses, Inc

The following reflects the findings of the California Department of Public Health during a recertification survey conducted June 2, 2025, through June 5, 2025. Census: 13 Unduplicated Admissions: 30 Home Visits with record reviews: 3 Record Reviews without home visits: 4 Sample Size: 7 The Condition of Participation for the Emergency Preparedness Program was met.

The following reflects the findings of the California Department of Public Health during a recertification survey conducted June 2, 2025, through June 5, 2025. Census: 13 Unduplicated Admissions: 30 Home Visits with record reviews: 3 Record Reviews without home visits: 4 Sample Size: 7 Four deficiencies were issued during the recertification survey.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the patients' initial assessment was completed within 48 hours of the physician's referral date or on the physician-ordered start of care date for one of seven sampled patients (Patient 4). This failure had the potential to cause a delay in the determination of Patients 4’s immediate care and support needs. Findings: A review of Patient 4’s face sheet (a document that gives a summary of patient's information), undated, indicated a start of care date of March 30, 2025, with a certification period of March 30, 2025, to May 28, 2025. Patient 4 had diagnoses that included pneumonia (a lung infection). A review of Patient 4’s physician’s referral order dated March 27, 2025, indicated, “Discharged today on home health for physical therapy, medication management and safety evaluation.” A review of Patient 4’s initial assessment, dated March 30, 2025, indicated the initial assessment had been conducted on March 30, 2025. The initial assessment had been completed three days after the physician’s referral order. A review of a Communication Note, dated March 28, 2025, indicated, “Patient and family requested for visit to be done on Sunday, [Primary Medical Doctor] aware.” During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on June 4, 2025, at 1:52 PM, the Admin/DPCS stated after learning of Patient 4 and family’s request, the Admin/DPCS would not confirm or deny that a physician’s order had been obtained for the new start of care date. A review of the agency’s policy and procedure titled “Initial and Comprehensive Assessment,” dated January 2008, indicated, “POLICY: …The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of the patient’s return home, on the start of care date ordered by the physician, … or at the patient/family request with the approval of the physician.”

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 agency failed to ensure a review of all the medications the patients were taking was conducted for one of seven sampled patients (Patient 1) when the Medication Profile (MP), indicated: a. Fluocinonide external (a topical medication applied to the skin to reduce inflammation, swelling, and itching) 0.05 (five)% (percent) apply to scalp daily and Patient 1's wife stated the fluocinonide was stopped one week ago and Patient 1 was now using [Brand Name] shampoo. b. Systane eye drops (artificial tears designed to relieve dry eye symptoms), instill (to put in) 2 (two) drops into each eye 2 times daily and Patient 1's wife stated she was instilling 1 (one) drop in each eye, 3 (three) times daily for the past 2 weeks as directed by the doctor. c. Tacrolimus external (a topical medication applied to dry and itchy patches of the skin) 0.1%. Apply to skin rash 2 times daily as needed and Patient 1's wife stated Patient 1 was not using the tacrolimus but did not remember went it was stopped. d. Clobex spray external (a topical medication applied to the skin to reduce inflammation and itching) 0.05%, 59 ml (milliliters-a unit of measurement) spray to affected area(s) 2 times daily as needed. The MP did not indicate the special instructions on the pharmacy label which indicated, "Apply to affected areas on body twice daily after moisturizing cream twice. Take at least one week break before reapplying cycle, avoid face." This failure had the potential to cause Patient 1 to suffer ineffective drug therapy, significant side effects and noncompliance with drug therapy. Findings: A review of Patient 1’s care plan (contains information about a patient's diagnosis, the goals of treatment, and specific nursing orders), undated, indicated a start of care date of December 29, 2023, with a recertification period of April 22, 2025, to June 20, 2025. Patient 1 had diagnoses that included non-rheumatic mitral valve disorder (a condition where the mitral valve, which separates the two left chambers of the heart, becomes damaged due to weakening of the valve tissue, leading to leakage of blood across the valve). During a home visit on June 3, 2025, with the Administrator/Director of Patient Care Services (Admin/DPCS) and Patient 1’s wife, an observation of Patient 1’s actual medication bottles available in the home were compared with Patient 1’s most current Medication Profile (MP). During a concurrent observation and interview on June 3, 2025, from 10:54 AM, to 11:16 AM with the Admin/DPCS and Patient 1’s wife: The Admin/DPCS and Patient 1’s wife confirmed a Registered Nurse (RN 1) had visited Patient 1 and reviewed all his medications yesterday (June 2, 2025). a. The MP indicated fluocinonide external 0.05%, apply to scalp daily. Patient 1's wife stated Patient 1 had been using the fluocinonide for a long time but stopped last Tuesday (May 27, 2025) and Patient 1 was now using [Brand Name] shampoo. b. The MP indicated Systane eye drops instill 2 drops into each eye, 2 times daily. Patient 1's wife stated she was instilling 1 drop in each eye, 3 times daily for the past 2 weeks as directed by the doctor. c. The MP indicated tacrolimus external 0.1%. Apply to skin rash 2 times daily as needed. Patient 1's wife stated Patient 1 was not using the tacrolimus but did not remember went it was stopped. d. The MP indicated Clobex spray external 0.05%, 59 ml spray to affected area(s) 2 times daily as needed. Patient 1’s wife provided the pharmacy labeled packaging for the Clobex spray and the pharmacy label indicated "Apply to affected areas on body twice daily after moisturizing cream twice. Take at least one week break before reapplying cycle, avoid face." The MP did not indicate the special instructions indicated on the pharmacy label. The Admin/DPCS confirmed the discrepancies on the MP and stated RN 1 should have updated the MP with the information provided by Patient 1’s wife at her visit on June 2, 2025. During an interview with RN 1 on June 3, 2025, at 12:45 PM, RN 1 stated the Admin/DPCS asked her to visit Patient 1 on June 2, 2025, and review Patient 1’s medications. RN 1 stated she had spoken to Patient 1 about his medications, not Patient 1’s wife and Patient 1 did not tell her about the changes for the fluocinonide, Systane eye drops, or tacrolimus external. RN 1 stated she had not looked at the pharmacy label for the Clobex spray and was unaware of the special instructions. A review of the agency’s policy and procedure titled “Medication Profile,” dated January 2008, indicated, “PURPOSE: To define the use of the medication profile in evaluating a patient’s medication regimen. POLICY: Patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications. Procedure: … 4. During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver, as well as other clinicians, understand the medication regimen. This includes, but will not be limited to: A. Using the medication profile, in conjunction with other pertinent data, to evaluate the use of the drugs in the home setting B. Using the medication profile to teach the purpose of medication, dosages, routes, administration times, side effects, and contraindications C. Using the medication profile as a communication tool for other clinicians involved in care.”

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 agency failed to ensure the patients' clinical record included all the physician's orders for one of seven sampled patients (Patient 1) when Patient 1's referral order was not in Patient 1's clinical record. This failure had the potential to cause Patient 1 not to receive the prescribed care, the inability of healthcare providers to track the patient's treatment plan over time, and a lack of clear records for legal and regulatory purposes. Findings: A review of Patient 1’s care plan (contains information about a patient's diagnosis, the goals of treatment, and specific nursing orders), undated, indicated a start of care date of December 29, 2023, with a recertification period of April 22, 2025, to June 20, 2025. Patient 1 had diagnoses that included non-rheumatic mitral valve disorder (a condition where the mitral valve, which separates the two left chambers of the heart, becomes damaged due to weakening of the valve tissue, leading to leakage of blood across the valve). A review of Patient 1’s physician’s orders from December 29, 2023, to June 2, 2025, was conducted. There was no documented evidence to show a physician’s referral order for home health services had been received. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on June 2, 2025, at 4 PM, the Admin/DPCS confirmed a physician’s referral order was not in Patient 1’s clinical record. A review of the agency’s policy and procedure titled “Entries into the Clinical Record,” dated January 2008, indicated, “POLICY: Home health personnel providing direct patient care and supervisory functions have authority to make entries into the clinical record. Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided. The record format will be reviewed and updated as necessary. PROCEDURE: 1. A clinical record will be initiated and maintained for each patient receiving care or services, according to organization policies found in this manual, and will include at a minimum: … C. Physician (or other authorized licensed independent practitioner) orders and evidence of physician oversight activities. …”

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the clinical record contained a completed discharge summary sent to the Primary Care Practitioner (PCP) within five business days of the patient’s discharge for one of seven sampled patients (Patient 6). This failure had the potential to cause Patient 6’s physician being unaware of the patient’s status, including problems identified at admission and during care, progress towards goals, medical status at discharge, and continuing symptom management needs. Findings: A review of Patient 6’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of December 26, 2024, with a recertification period of February 24, 2025, to April 24, 2025. Patient 6 had diagnoses that included open wound to scalp. Patient 6 was discharged on April 14, 2025. A review of Patient 6’s discharge order dated April 15, 2025, indicated “Per [Skilled Nurse] … report dated [April 15, 2025], [Patient 6] was admitted to a behavioral hospital (hospital name not disclosed) secondary to [Patient 6] trying to commit suicide by cutting his skin wrist, this report to [SN] was given by [Patient 6’s] father … Discharge [Patient 6] from [name of agency] secondary to patient admission to the hospital effective [April 14, 2025].” A review of Patient 6’s discharge summaries from December 26, 2024, to June 4, 2025, was conducted. There was no documented evidence to show a discharge summary had been completed and sent to the PCP. A review of Patient 6’s discharge assessment dated April 14, 2025, was conducted. There was no documented evidence to show the discharge assessment contained: a. The status of problems identified at admission and during the provision of care. b. The progress toward goals/desired outcomes. c. Medical status at discharge, including continuing symptom management needs. d. The overall status of the patient. e. A summary of care or services provided. During an interview with the Administrator/Director of Patient Care Services (Admin/DPCS) on June 4, 2025, at 4:19 PM, the Admin/DPCS stated Patient 6’s discharge assessment was considered as Patient 6’s discharge summary. The Admin/DPCS refused to confirm or deny that the discharge assessment contained: the status of problems identified at admission and during the provision of care, the progress toward goals/desired outcomes, medical status at discharge, including continuing symptom management needs, the overall status of the patient, or a summary of care or services provided or that a discharge summary had been sent to the PCP within five days of Patient 6’s discharge. A review of the agency’s policy and procedure titled “Discharge Summary,” dated January 2008, indicated, “PURPOSE: To define requirements for documentation of service discontinuation and when patients are discharged from the organization. POLICY: Each patient discharged from a service and from the organization will have a written discharge summary filed in the clinical record. PROCEDURE: 1. Each clinician who provides care will complete a discharge summary at the time his/her discipline is discharged, which may include, as appropriate: … D. The status of problems identified at admission and during the provision of care. E. The progress toward goals/desired outcomes. F. Medical status at discharge, including continuing symptom management need. G. The overall status of the patient. H. A summary of care or services provided. 2. The discharge summary and other relevant clinical record documents will be completed and submitted within 72 hours of discharge from service. 3. A copy of the discharge summary will be provided to the patient’s physician, when requested.”

The following reflects the findings of the California Department of Public Health during a Recertification Survey conducted May 9, 2022 through May 12, 2022. Representing the Department of Public Health: Surveyor: 33786 41459 Census: 25 Unduplicated Admissions: 50 Home Visits with Record Reviews: 3 Record Reviews without Home Visits: 4 Sample Size: 7

The following reflects the findings of the California Department of Public Health during a Recertification Survey conducted May 9, 2022 through May 12, 2022. Representing the Department of Public Health: Surveyor: 33786 41459 Census: 25 Unduplicated Admissions: 50 Home Visits with Record Reviews: 3 Record Reviews without Home Visits: 4 Sample Size: 7

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined 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 the Skilled Nurse (SN) had the correct size of Foley catheter (a tube inserted into the bladder to drain urine) for one of seven (7) sampled Patients (Patient 5) when Patient 5’s Foley catheter was dislodged and the SN did not have replacement. This failure had the potential for Patient 5 to have retention of urine and to be sent out to the hospital. Findings: During an observation of Patient 5 on May 11, 2022, at 11:00 AM, Patient 5 was lying in bed. She had a Foley catheter. During an interview with Patient 5’s care giver (CG) on May 11, 2022, at 11:15 AM, the CG stated, “My mom’s catheter came out. It needed to be replaced. The nurse did not have a new one. I was told to take my mom to the hospital.” During a review of Patient 5’s physician’s orders dated April 30, 2022, indicated, “Replace Foley Catheter French (Fr-size of the catheter) balloon of 20-30 cubic centimeter (cc-a unit of measurement).” During a review of the Skilled Nursing Visit nursing notes dated April 20, 2022, at 9:30 AM, the Licensed Vocational Nurse (LVN 1) documented, “…upon filling the balloon with water I found the balloon was faulty, did not hold water correctly. There was another catheter, but it was the wrong size. Skilled Nurse (SN) contacted [name of the Director of Nursing services] she will order another catheter that will arrive tomorrow and the RN will be able to put the new one in. SN instructed the care giver to go to Emergency Room (ER) to have a new one inserted…” During an interview with the Director of Nursing Services (DNS) on May 11, 2022, at 4 PM, the DNS confirmed LVN 1 did not have the correct size of catheter. The DNS stated, “I ordered a new one and it was delivered the next day.” During a review of the Patient 5's face sheet (a document which contains basic information about the client) had a start of care date of March 1, 2022, with a recertification period of April 30, 2022, through June 28, 2022. Patient 5 had diagnoses which included retention of urine. Further review of Patient 5’s face sheet, under “Patient Risk Profile,” it indicated, “Multiple emergency department visits (2 or more) in the past 6 months.” A request was made for the HHA’s policy and procedure concerning Foley catheters. The HHA did not provide a policy and procedure.

Access to auxiliary aids and language service CFR(s): 484.50(c)(12) Be informed of the right to access auxiliary aids and language services as described in paragraph (f) of this section, and how to access these services. This ELEMENT is not met as evidenced by: Based on interview, and record review, the home health agency (HHA) failed to provide information on how to access auxiliary aids and language services to one of 7 sampled Patients (Patient 5) when Patient 5 and Patient 5's Caregiver (CG) were Spanish speaking. This failure had the potential to cause a communication barrier when Patient 5 and Patient 5’s CG were not to be informed on how to access auxiliary aids and language services. Finding: During a home visit observation on May 11, 2022, at 11:25 AM with Patient 5, she was laying in bed. Patient 5 and Patient 5's CG are Spanish speaking. Further observation, Patient 5's HHA admission packet was on top of the table. During a review of Patient 5's admission packet, the admission packet did not contain information on how to access auxiliary aids and languages. During an interview with Patient 5’s CG on May 11, 2022, at 11:30 AM, Patient 5’s CG stated, "I did not receive any information about languages translator services. I would have like to have known." She further stated, “I speak very little English.” During an interview with the Director Of Nursing Services, (DNS) on April 28, 2022, at 9:45 AM, DNS confirmed Patient 5 and Patient 5’s CG did not have information on how to access auxiliary aids and languages. The DNS stated, "We have not been doing that. I will fix it right away." During a review of the Patient 5's face sheet (a document which contains basic information about the client) had a start of care date of March 1, 2022, with a recertification period of April 30, 2022, through June 28, 2022. Patient 5 had diagnoses which included retention of urine. A request was made for the agency's policy and procedure concerning the right to access auxiliary aids and languages services. The agency did not provide a policy and procedure.

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 agency failed to ensure a review of the medications was conducted for patients in the home for two (2) of seven (7) sampled patients (Patients 6 and 7) 1. For Patient 6, the medication, Ferrous Sulfate (a medication used to treat and prevent iron deficiency anemia), on the medication profile (MP- a current list of all medications prescribed for a specific patient), indicted a wrong frequency (defines how often the medication is to be administered as events per unit of time). 2. For Patient 7, the medication, Beet Root (supplement to improve blood flow, lower blood pressure, and increase exercise performance), on the medication profile, indicated the wrong dosage ( the amount of drug taken at any one time). This failure had the potential to cause ineffective drug therapy, significant side effects, and non- compliance with drug therapy. 1. A review of Patient 6’s face sheet (a document that gives a summary of a patient’s information), undated, indicated a start of care of April 8, 2022, with a certification period of April 8, 2022, through June 6, 2022. Patient 6 diagnoses included: chronic pain (persistent pain that last weeks to years), and Iron deficiency anemias (too few healthy red blood cells due to too little iron in the body, without enough iron, red blood cells can’t carry enough oxygen to body tissues). During a home visit on May 11, 2022, with the Physical Therapist Aide - PTA (work under the direction and supervision of a Physical Therapist. They help patients who are recovering from injuries and illnesses to regain movement and manage pain) and in the presence of Patient 6, an observation was made of Patient 6’s actual medication bottles available in the home and compared with Patient 6’s Medication Profile (MP – a current list of all medications prescribed for a specific patient). During an interview with Patient 6 on May 11, 2022, at 11:20 AM, Patient 6 stated, “I take my Ferrous Sulfate one (1) time a day.” Patient 6 provided the following medication bottle: Ferrous Sulfate, a medication used to treat and prevent iron deficiency anemia. Iron helps the body to make healthy red blood cells which carry oxygen around the body), 325mg (milligrams – a unit of measure), take one (1) tablet by mouth daily. The medication order date was January 31, 2020. The home health agency had the medication as Ferrous Sulfate take one (1) tablet by mouth 2 times daily. During an interview with the PTA on May 11, 2022, at 11:30 AM, he stated, “the nurses usually go over the medications with the patient”. 2. A review of Patient 7’s face sheet, undated, indicated a start of care date of April 21, 2022, with a certification period of April 21, 2022, through June 19, 2022. Patient 7’s diagnoses included: bilateral primary osteoarthritis (a form of arthritis, it occurs when the protective cartilage that cushions the ends of the bones wears down over time, the disorder most commonly affects joints in your hands, knees, hips and spine), and low back pain (a common painful condition affecting the lower portion of the spine, caused by injury to a muscle or ligament). During a home visit on May 11, 2022, with a Licensed Vocational Nurse (LVN – provide patients with quality care and comfort measures under the supervision of a registered nurse) work) and in the presence of Patient 7, an observation was made of Patient 7’s actual medication bottles available in the home, they were compared with Patient 7’s Medication Profile (MP – a current list of all medications prescribed for a specific patient). During an interview with Patient 7 on May 11, 2022, at 1:15 PM, Patient 7 stated, “I take the beet root that is in the bottle on the table.” Patient 7 provided the following medication bottle: Beet root 1500 mg, (milligrams – a unit of measure), take one capsule by mouth three (3) times daily. The medication order date was, February 21, 2022, the home health agency had the medication as: Beet root 1000mg, take one (1) capsule by mouth 3 times daily. During an interview with the LVN on May 11, 2022, at 1:20 PM, she concurred that the dosages of the beet root was less than what Patient 7 was taking. During a record review of the agency policy and procedure, titled, “Medication Profile,” revised January 2008, indicated the following: “Purpose: To define the use of the medication profile in evaluating a patient’s medication regimen, Policy: Patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications. Procedure: 1. For accuracy and to completely reconcile medications across the continuum of care, the admitting organization will obtain and document a complete list of the patient’s current medications upon the patient’s entry to the organization. A comparison of the medications ordered for the patient while under the organization’s care will be made to those on the list. 2. The admitting nurse will initiate a medication profile to document the current medication regimen, including name, strength, dose, route, frequency, date and time of administration and a diagnosis, condition, or indication for use for each medication ordered, A. In rehabilitation therapy-only cases, the patient’s therapist must submit a list of patient medications to a registered nurse for review. 3. A drug regimen review will be performed at the time of admission, when updates to the comprehensive assessments are performed, and when care is resumed after a patient has been placed on hold. The review will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicative drug therapy, and noncompliance with drug therapy omissions and unclear information, 4. During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver, as well as other clinicians, understand the medication regimen. This includes, but will not be limited to: A. Using the medication profile, in conjunction with other pertinent data, to evaluate the use of the drugs in the home setting, B. Using the medication profile to teach the purpose of medication , dosages, routes, administration times, side effects, and contraindications, C. Using the medication profile as a communication tool for other clinicians involved with care, 9. Deviations in taking medications as ordered will be documented in clinical notes, and the physician (or other authorized licensed independent practitioner) will be notified. An incident report will be filed as necessary.”

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to document performance improvement projects (PIP-a concentrated effort on a particular problem in one area of the agency or agency wide, it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the HHA had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved. This failure had the potential to cause the HHA’s problems to go unresolved. Findings: During a review of the HHA’s Quality Assessment and Performance Improvement (QAPI) program on May 10, 2022, at 10:10 AM, with the Director of Nursing Services (DNS). There was no documented evidence of the of PIP undertaken by the HHA, reasons for conducting PIPs, or measurable goals to show progress achieved on the PIPs. During an interview with the DNS on May 10, 2022, at 10:30 AM, the DNS stated she was the person responsible for the QAPI program. The DNS stated, “I do not have the documentation.” The DNS could not show documentation for the PIP, why the HHA decided to conduct the PIP or a measurable goal to show progress on the PIP. During a review of the HHA’s policy and procedure titled, “[name of the agency] Policy and Procedure for QAPI,” undated, indicated, “PIP is implemented in accordance with CMS protocol conducting PIPs, including: 1. Measurement of performance using objective quality indicators, 2. Implementation of systems intervention to achieve improvement in quality, 3. Evaluation of the effectiveness of the interventions, 4. Plan and initiation of activities for increasing or sustaining improvement.”

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to follow their policy and procedure when the HHA did not track and document the COVID-19 ( a respiratory disease which causes difficulty in breathing) vaccination status of staff who received COVID 19 vaccines and boosters doses. This failure resulted in the HHA not being able to accurately account for the COVID 19 vaccinations status of their staff as per their policy and procedure not following their policy and procedure for tracking and documenting the COVID 19 vaccination status of staff. Finding: During a review of the HHA document titled, “Appendix E: Documentation of Employee COVID 19 Vaccination Status,” with the Director of Nurses Service (DNS) on May 9, 2022, at 9:15 AM, the documentation of employee COVID 19 vaccination status was found to not be done. Further review of the HHA document titled, “Appendix E: Documentation of Employee COVID 19 Vaccination Status,” with the DNS, indicated there was no documented evidence the HHA tracked and documented staff who received COVID 19 vaccination and boosters. During an interview with the Director of Nursing Services (DNS) on May 9, 2022, at 9:30 AM, the DNS confirmed there was no tracking and documentation for staff who obtained COVID 19 vaccination and boosters. The DNS stated, “My staff have received the vaccines. I do not have documentation. I will fill out the Appendix E: Documentation of Employee COVID 19 Vaccination Status.” During a review of the Medicare and Medicaid Programs; Ominibus COVID 19 Health Care Staff Vaccination document titled, “Home Health Agency (HHA) Attachment QSO-22-09-ALL” undated, indicated, “A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC.” A review of the agency’s policy and procedure titled, “COVID 19 Prevention (CPP) for [name of HHA]” undated, indicated, “Document the vaccination status of our employees by using Appendix E: Documentation of Employee COVID 19 Vaccination Status, which is maintained as a confidential medical record.”

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to obtain criminal background checks on employees who have direct patient contact and/or access to patient records for six (6) of nine (9) employee files reviewed, (Registered Nurses 1,2,and 3, Licensed Vocational Nurse 1 and 2, Masters of Social Work 1). This failure had the potential to create criminal activity involving patients, families, or caregivers. During an interview with the Director of Patient Care Services (DPCS – a supervisor position that combines administrative skills with nursing knowledge) on May 12, 2022, at 9:00 AM, she concurred that six (6) of the nine (9) employee files (RN 1,2,and 3, LVNs 1 and 2 and MSW 1)were missing a background check. During a record review of employee files on May 10, 2022 at 1:00 PM, indicated, three (3) Registered Nurses (RN – provides and coordinates patient care and educates patients and the public about various health conditions), two (2) Licensed Vocational Nurses (LVN – observe patients, perform basic assessments, and report and document changes in a patient’s condition) and one (1) Masters Social Work (MSW – a graduate degree in social work) did not have a background check when employee files were reviewed. During a record review of the agencies policy and procedure titled, “Personnel Record Contents”, revised January 2008, indicated the following: “Purpose: To specify the content of the personnel files for personnel and contract organization staff, Policy: The home health agency will maintain accurate and complete personnel files on all staff. Personnel files are confidential files of the organization. All health related information on personnel will be kept in a separate file to maintain confidentiality according to the Americans and Disabilities Act. Upon request, the organization will provide personnel with a copy of all confidential information being placed in the file. If staff make a written request to the Executive Director/Administrator, the staff may review and make notes regarding information contained within their file. Procedure: 1. Content of personnel files for regular full or part time personnel will include: New Hire Documents – J. Criminal background checks, Per Diem Personnel – 1. The content of the personnel files for per diem and contract organization personnel will include: New Hire Documents – G. Criminal background checks.” During a record review of the agencies policy and procedure titled, “Selection/Hiring of Personnel”, revised on January 2008, indicated the following: “Purpose: To specify the criteria for selection of staff to meet the care needs of appropriate patients, Policy: The organization defines the qualifications and competencies for staff positions based on its mission, population and care, treatment and service goals. The organization will provide promotion and advancement opportunities in a nondiscriminatory fashion, Procedure: Hiring – 2. A criminal background check will be obtained for positions required by law regulation, or organizational policy.”