Every finding on record at 247 Allstaff West LLC

The following reflects the findings of the California Department of Public Health during the investigation of complaint #CA00116497. The inspection was limited to the specific complaint investigated and does not represent the findings of a full inspection of the agency. PROVIDER WAS TERMINATED EFFECTIVE 6/19/25.

Discharge Planning CFR(s): 484.58 Condition of Participation: Discharge planning. This CONDITION is not met as evidenced by: Based on interview, record review and the agency's policy and procedure, it was determined the Home Health Agency (HHA) failed to implement a safe and coordinated discharge planning process to effectively transition patients upon discharge from home health services (G 0562). The extent and effect of this practice resulted in the agency's inability to ensure the discharge plan was properly coordinated to ensure patients' safety and continuity of care.

Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to implement a safe and coordinated discharge from home health services for two sampled patients (Patient 1 and Patient 2), when Patient 1 and Patient 2 had unplanned discharges from home health services with less than 24 hour notice and no follow up care arranged. This failure resulted in Patient 1 and Patient 2 not receiving home health services jeopardizing Patient 1 and Patient 2's health and safety. Findings: A review of a letter to the HHA titled "Home Health Agency Notice of Medi-Cal (public health program for Medicaid patients in California) Termination," dated 6/19/25, indicated "...Based on findings of a recertification survey performed on May 14, 2025, the California Department of Public Health (CDPH) Centralized Applications Branch (CAB) has determined that [Name of Agency] is not substantially compliant with the Medicare requirements for Home Health Agencies... Therefore, [Name of Home Health Agency]'s Medi-Cal certification will be terminated, and all payments ended effective April 29, 2025..." A review of Patient 1's "Home Health Certification and Plan of Care (POC)," for certification period 5/22//25 to undated, indicated Patient 1 had Start of Care (SOC) with the HHA in January 2015 with multiple diagnoses including spastic quadriplegic cerebral palsy (a severe form of cerebral palsy, abnormal brain development, causing paralysis of both arms and legs), tracheostomy (artificial opening in the neck directly to the trachea (windpipe) so air can reach the lungs), epilepsy (seizure disorder), chronic respiratory failure (lungs cannot adequately provide oxygen to the body), diabetes (too much glucose in the blood), and ventilator dependence (relies on a mechanical ventilator to breathe). Further review of Patient 1's POC indicated "...Orders for Discipline and Treatments...SN [Skilled Nurse]: 5 x a week, Nights 11:00pm -7:00am Tuesday, Wednesday, Thursday, Friday Saturdays 3:00pm to 11:00 pm..." A review of Patient 1's "Non-oasis [assessment tool] discharge," dated 6/19/25, indicated "...client being discharged due to CDPH recommendation..." A review of a letter from the HHA to Patient 1's Responsible Party and caregiver, dated 6/19/25, indicated "...It is our determination that we as an agency are unable to continue providing care for [Patient 1] and will terminate services as the home health agency provider as of 6/19/25...We recommend that you promptly find another home health agency...Any delay could jeopardize your continuity of care, so we urge you to act promptly..." A review of Patient 2's POC, for certification period 5/2/25 to 7/2/25, indicated Patient 2 had SOC with the HHA in September 2016 with multiple diagnoses including quadriplegia (paralysis of upper and lower body), laryngectomy (removal of the larynx or voice box), neuromuscular dysfunction of the bladder (nerves controlling bladder function are impaired causing difficulties storing and emptying urine), and moderate chronic kidney disease (loss of function of the kidneys that remove waste from the body). Further review of Patient 2's POC indicated "...Orders or Discipline and Treatment...SN 7:00am -3:00pm Monday through Friday..." A review of Patient 2's "Non-oasis discharge," dated 6/19/25, indicated "...Discharging client due to mandate from CDPH to discharge MediCal patients..." A review of a letter from the HHA to Patient 2's Responsible Party and caregiver, dated 6/19/25, indicated "...It is our determination that we as an agency are unable to continue providing care for [Patient 2] and will terminate services as the home health agency provider as of 6/19/25...We recommend that you promptly find another home health agency...Any delay could jeopardize your continuity of care, so we urge you to act promptly..." During a telephone interview on 6/20/25 at 1:28 p.m. with the Administrator (ADM), the ADM stated the HHA received a letter on 6/19/25 from CDPH stating the HHA will not receive payment from Medi Cal from 4/29/25 onward. The ADM stated Patient 1 and Patient 2 were notified on 6/19/25 and discharged from the HHA on 6/19/25 due to not receiving Medi Cal payment for home health services. The ADM stated Patient 1 and Patient 2 were long term patients and their caregivers were upset with the discharge. The ADM stated was directed to stop services for Patient 1 and Patient 2 on 6/19/25 for financial reasons and patients will not be seen going forward. When asked if referral was made to another HHA, the ADM stated the referral needs to come from the physician. The ADM stated the patients' physicians were notified but were not asked to provide referrals to other HHAs. During a telephone interview on 6/20/24 at 3:04 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated she was aware of an email sent from CDPH on 6/19/25 that was interpreted as the HHA should discharge Medi Cal patients. The DPCS stated she notified Patient 1's caregiver on 6/19/25 that Patient 1 was discharged from services due to "CDPH mandate." The DPCS stated she felt directed to discharge the patients. The DPCS stated that termination of payment meant no longer providing services. The DPCS started Patient 1 required services to manage diabetes, bowel regimen, tracheostomy, and ventilator. The DPCS stated Patient 2 required services to manage transfers due to quadriplegia, medication administration, ADL (Activities of Daily Living) care, and small pressure area (injury to skin from pressure) on coccyx (bottom of spine). When asked how soon notification should be given for discharge from services, the DPCS stated, "Haven't done this before. Twenty-four hours would be my guess. Would notify the family and physician to coordinate prior to discharge." The DPCS stated there was no plan to discharge Patient 1 and Patient 2 prior to receipt of letter from CDPH. When asked if these were safe discharges, the DPCS stated, "...Agree that if had forty-eight hours would have gone smoother. Was scrambling yesterday." The DPCS stated that services were terminated to Patient 1 and Patient 2, because the letter received was interpreted that terminated payment meant to discharge patients from services. The DPCS stated, "Did not interpret as termination of Medi Cal payment only." The DPCS stated she was not aware of any attempt to transfer care to another HHA. When asked how she would refer a patient to another agency, the DPCS stated, "...Not sure. Has never discharged another client before." The DPCS stated that physicians were notified on 6/19/25 via fax of discharge but no one talked with the physicians personally. The DPCS stated the physicians would be expected to make the referrals to another HHA. The DPCS stated it was challenging communicating with the physicians and did not know if the physicians will follow through with the referral or not. The DPCS stated Patient 1 and Patient 2 need long term services and without services the family will be the 24/7 caregivers without any respite. The DPCS stated the patients need care without interruption and discharge from services will impact their care. During a telephone interview on 6/20/25 at 4:53 p.m. with Patient 1's Family Member (FM), Patient 1's FM stated was notified of Patient 1's discharge from home health services on 6/19/25 because agency was not being paid and could not send a nurse. Patient 1's FM stated did not have a nurse last night on 6/19/25. Patient 1's FM stated, "Have to take care of [Patient 1] 24/7. It is hard on me...Get burnt out with 24-hour care... [FM] does not sleep well... [FM] needs to hear machine... [Patient 1] needs to be suctioned at night..." During a telephone interview on 6/20/25 at 5:07 p.m. with Patient 2's FM, Patient 2's FM stated she was notified on 6/19/25 that the HHA would no longer provide services to Patient 2. Patient 2's FM stated she needs to find another HHA but was disappointed because Patient 2 has had the same nurse caring for him for many years. A review of the HHA's Policy and Procedure (P&P) titled "Discharge Criteria and Process," not dated, indicated "...When the patient's plan of treatment changes and this change results in discharge from or reduction of services, the patient or his/her representative, as well as his/her primary physician, will be notified and involved in planning decisions...When able, [name of agency] will notify the patient of the decision to terminate or reduce services within one (1) visit prior to the time the change in service is to occur... For a patient requiring continuing care, assistance will be given to the patient and family/caregiver in order to manage continuing care needs after the organization's services are discontinued..." This P&P did not indicate services will be terminated if there is discontinuation of insurance payment for services. A review of the HHA's P&P titled "Discharge Planning," not dated, indicated "... Patient will not be discharged without appropriate preparation. The patient's continuing care needs will be assessed on an ongoing basis, as well as at discharge. Information will be provided to assist the patient in planning his/her discharge, including referral and transfer...Clinicians will assist patients regarding their discharge by: ...Consulting with the patient and family/caregiver regarding plans for discharge from the organization... Coordinating discharge with the patient's physician..." A review of the HHA's P&P titled "Discharge Summary," not dated, indicated "...Each clinician who provides care will complete a discharge summary at the time his/her discipline is discharged, which may include...The reason for discharge, including...the name of the organization to which the patient is being transferred..."

The patient's representative (if any); CFR(s): 484.55(c)(7) The patient's representative (if any); This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Comprehensive Assessments reflected the patients' representative for 3 of 10 sampled patients (Patient 8, Patient 9, Patient 10). This failure resulted in Patient 8, Patient 9 and Patient 10's Representatives to be unaware of the patients' home health goals, services, and needs. A review of Patient 8's clinical record indicated Patient 8 had SOC date with the HHA on1/16/18 with diagnoses of diabetes and psychosis (a mental disorder characterized by disconnection from reality). A review of Patient 8's form "Rights/Responsibilities," signed 3/20/25, indicated it was not signed by Patient 8 and name was printed on the form. A review of Patient 8's "Recertification (Comprehensive Assessment)," dated 4/4/25, did not indicate Patient 8's representative. A review of Patient 9's clinical record indicated Patient 9 had SOC date with the HHA on 1/10/15 with multiple diagnoses including quadriplegia (paralysis of all four limbs and torso), cerebral palsy (brain damage that affects movement and posture), epilepsy (seizure disorder) and diabetes. A review of Patient 9's form "Rights/Responsibilities," signed 3/20/25, indicated it was not signed by Patient 9 and name was printed on the form. A review of Patient 9's "Recertification (Comprehensive Assessment)," dated 4/19/25, did not indicate Patient 9's representative. A review of Patient 10's clinical record indicated Patient 10 had SOC date with the HHA on 6/17/16 with diagnosis of atonic colon (lack of muscle tone or strength in the bowel causing sluggish movement of stool). A review of Patient 10's form "Rights/Responsibilities," not dated when signed, indicated it was not signed by Patient 10 and name was printed on form. A review of Patient 10's "Recertification (Comprehensive Assessment), dated 4/17/25, did not indicate Patient 10's representative. During an interview on 5/13/25 at 10:45 a.m. and 11:00 a.m. with the HHA Administrator (ADM), the ADM stated that home visits were conducted on 3/19/25 and 3/20/25 by the ADM and Staffing Coordinator (SC) to obtain signatures for the "Rights/Responsibilities" form. The ADM stated signatures were obtained for all current patients. When asked if the legal representatives for the patients signed the "Rights/Responsibilities" form, the ADM stated, "Don't know who signed the forms. If it was the legal representative, we don't have proof of legal representative for any patient." The ADM further stated there was no documentation of legal representative for any patient in the electronic record. During an interview on 5/14/25 at 11:10 a.m. with Registered Nurse (RN) 1, RN 1 acknowledged Patient 8's Comprehensive Assessment did not indicate Patient 8's legal representative. During an interview on 5/14/25 at 1:00 p.m. with the ADM, the ADM stated most of the patients are in group homes and the group home manager or owner has been the contact for the HHA. The ADM stated she does not know if patients have legal representatives to make health care decisions either family or legal guardians. The ADM stated some patients have families but was not sure if family members are the legal representatives to make health care decisions. The ADM stated she was not sure who should be making healthcare decisions for the patients. A review of the HHA's Policy and Procedure (P&P) titled "Rights/Responsibilities," not dated, indicated "...Each patient has the right to be informed of his or her rights as a patient of the agency...A patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative... This representative, on behalf, of the patient, may exercise any of the rights provided by the policies and procedures establish by the organization...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation or organization services...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record..." A review of the HHA's P&P titled "Home Health Recertification Policy," not dated, indicated "...The purpose of this policy is to establish guidelines for the recertification process in home health care, ensuring that patients continue to receive appropriate and necessary services... Recertification Process: ...Care Plan Review: The patient's care plan will be reviewed and updated based on the assessment findings, ensuring that it aligns with the patient's goals, preferences, and changing needs...Communication and Patient Involvement: ...The recertification process will involve open and transparent communication with the patient, their family/caregiver, and other healthcare providers involved in the patient's care...Patients will be informed of the recertification process, its purpose, and their right to participate in decision-making regarding their continued care...Patients and their families/caregivers will be encouraged to provide feedback, express concerns, and actively participate in the development and review of the care plan during the recertification process..."

The following reflects the findings of the California Department of Public Health during a RECERTIFICATION and Emergency Preparedness Survey conducted 1/27/25 through 1/29/25. The agency reported 3 unduplicated annual admissions. The patient sample size was 7 and 3 home visits were conducted.

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, §485.542, §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 email correspondence and record review the home health agency (HHA) failed to comply with all applicable Federal, State and local emergency preparedness requirements referenced in Appendix Z of the State Operation Manual. The facility must establish and maintain an emergency preparedness program and encouraged to keep documentation for a period of at least 4 years. The emergency preparedness program must be in writing, reviewed every two years, and all facilities are expected to make the appropriate changes to their emergency program in the event changes are required more frequently outside of their update cycles. Facilities should ensure their emergency preparedness programs are aligned with their State and local emergency plans/pandemic plans. On an email correspondence with the Administrator, dated 1/28/25 at 3:35 p.m., the Administrator failed to present their Emergency Preparedness Program to the Department. As a result of this failure, the Department was unable to make a determination of compliance within this requirement including: >Validate that the agency had emergency preparedness policies and procedures >Verifying how the agency would evacuate homebound patients from their residences during an emergency situation >How the agency would evacuate homebound patients from their residences during an emergency situation >How the agency would communicate with staff and patients during service interruption; communicate with State and Local officials in the event of inability to reach staff or patients during an emergency situation >Verify if the agency had a communication plan that complies with Federal, State and Local laws that is updated at least every 2 years which included: Names and contact information for the Staff, entities providing services under arrangement, patients' physicians and Volunteers >Verify if the agency had EP training and testing supported by documentation as per the requirements >Validate that the agency at least annually conducted exercises to test their emergency plan

The following reflects the findings of the California Department of Public Health during a RECERTIFICATION SURVEY conducted 1/27/25 through 1/29/25. The agency reported 3 unduplicated annual admissions. The patient sample size was 7 and 3 home visits were conducted.

Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on interview and record review, it was determined the Home Health Agency (HHA) failed to ensure the patient and representative, have the right to be informed of the patient's rights in a language and manner the individual understands (G406); failed to provide the patient and the patient’s legal representative (if any), the following information in the Patient Rights during the initial evaluation visit, in advance of furnishing care to the patient (G410); failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities, and the HHA’s transfer and discharge policies and be accessible to individuals with disabilities (G412); failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities which included contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints (G414); failed to obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities (G418); failed to provide written notice of the patient's rights and responsibilities and the HHA's transfer and discharge policies to a patient-selected representative within 4 business days of the initial evaluation visit (G422); failed to have official documentation of any adjudication by a court that indicates that a patient lacks the legal capacity to make his or her own health care decisions and the name of any person identified by the court who may exercise the patient's rights (G424); failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities which included the right to have his or her property and person treated with respect (G428); failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities which included the right to be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property (G430); failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities which included make complaints to the Home Health Agency regarding treatment or care that is (or fails to be) furnished, and the lack of respect for property and/or person by anyone who is furnishing services on behalf of the HHA (G432); failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities, which included the right to consent or refuse care in advance of and during treatment, where appropriate (G434); failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities which included the right to receive all services outline in the plan of care (G436); failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities which included the right to have a confidential clinical record and access to or release of patient information and clinical records (G438); failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities which included being advised, orally and in writing, of the extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, the charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, the charges the individual may have to pay before care is initiated; and any changes in the information provided when they occur. The HHA must advise the patient and representative of these changes as soon as possible, in advance of the next home health visit (G440); failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities which included proper written notice, in advance of a specific service being furnished, if the HHA (home health agency) believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care (G442); failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities which included being 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 (G444); failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities which included being 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, the Agency on Aging, the Center for Independent Living, the Protection and Advocacy Agency, the Aging and Disability Resource Center; and the Quality Improvement Organization (G446); failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities which included the right to be free from any discrimination or reprisal for exercising his or her rights or for voicing grievances to the HHA or an outside entity (G448); failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities which included the right to be informed of the right to access auxiliary aids and language service, and how to access these services (G450); and failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities which included the right to be informed of the HHA's policies for transfer and discharge (G452). The extent and cumulative effect of these systemic practices resulted in the patient or their representative to be unaware of the patient rights and responsibilities and their rights being protected and promoted.

Information to patient CFR(s): 484.50(a)(1) Provide the patient and the patient's legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to provide the patient and the patient’s legal representative (if any), the following information in the Patient Rights during the initial evaluation visit, in advance of furnishing care to the patient for three of seven sampled patients (Patient 1, 2 and 3). This failure resulted in the patient or their representative to be unaware of patient rights and responsibilities and providing guidelines to assist in making decisions regarding care. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] and not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be found in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

Written notice of patient's rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient's rights and responsibilities under this rule, and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the patient and/or their representative received written notice of the patient’s rights and responsibilities, the HHA’s (home health agency) transfer and discharge policies and be accessible to individuals with disabilities for three of seven sampled patients (Patient 1, 2, and 3). This failure resulted in the patient or their representative unaware of the patient rights and responsibilities and the agency's transfer and discharge policies. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's clinical record indicated Patients 2's initial visit from the HHA was conducted on 10/14/24. During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be found in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the patient or their representative received written notice of the patient’s rights and responsibilities which included contact information for the HHA (home health agency) administrator, including the administrator's name, business address, and business phone number in order to receive complaints for one of seven sampled patients (Patient 1). This failure resulted in the patient or the patient's representative unaware of the patient rights and responsibilities and their rights are protected and promoted. During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be found in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information as follows:...The ownership or control of the organization"

Patient's or legal representative's signature CFR(s): 484.50(a)(2) Obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities for three of seven sampled patients (Patient 1, 2, and 3). This failure resulted in the patient and/or their representative unaware of the patient rights and responsibilities and their rights are protected and promoted. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information as follows:...The ownership or control of the organization" A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be found in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

Written notice within 4 business days CFR(s): 484.50(a)(4) Provide written notice of the patient's rights and responsibilities under this rule and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section to a patient-selected representative within 4 business days of the initial evaluation visit. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to provide written notice of the patient's rights and responsibilities and the home health agency's (HHA) transfer and discharge policies to a patient-selected representative within four business days of the initial evaluation visit for three of seven sampled patients (Patient 1, 2, and 3). This failure resulted in the patient and/or their representative unaware of the patient rights and responsibilities and their rights are protected and promoted. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed that there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be found in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

Exercise of rights CFR(s): 484.50(b)(1)(2)(3) Standard: Exercise of rights. (1) If a patient has been adjudged to lack legal capacity to make health care decisions as established by state law by a court of proper jurisdiction, the rights of the patient may be exercised by the person appointed by the state court to act on the patient's behalf. (2) If a state court has not adjudged a patient to lack legal capacity to make health care decisions as defined by state law, the patient's representative may exercise the patient's rights. (3) If a patient has been adjudged to lack legal capacity to make health care decisions under state law by a court of proper jurisdiction, the patient may exercise his or her rights to the extent allowed by court order. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to have official documentation of any adjudication by a court that indicates that a patient lacks the legal capacity to make his or her own health care decisions and the name of any person identified by the court who may exercise the patient's rights for three of seven sampled residents (Patient 1, 2, and 7). This failure resulted in the patient and/or their representative unaware of the patient rights and responsibilities and their rights to make his or her own health care decisions. A review of Patient 7's clinical records indicated Patient 7 had a start of care date with the HHA on 8/20/24 and was discharged on 9/27/24 with no diagnosis listed. Review of Patient 7's clinical record revealed no official documentation of any adjudication by a court that indicates that a patient lacks the legal capacity to make his or her own health care decisions and the name or contact information of any person identified by the court who may exercise the patient's rights. Further review of Patient 7’s clinical record revealed no written notice of patient/patient's representative rights and responsibilities. During an interview on 1/28/25 at 2 p.m. with the SC), the SC confirmed all documents for Patient 7 is in her clinical record. The SS stated she was not aware that documents pertaining to patient lacking capacity and their legal representative were needed in the clinical record. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be found in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder. Review of Patient 1's clinical record revealed no official documentation of any adjudication by a court that indicates that a patient lacks the legal capacity to make his or her own health care decisions and the name of any person identified by the court who may exercise the patient's rights.

Property and person treated with respect CFR(s): 484.50(c)(1) Have his or her property and person treated with respect; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the patient or their representative received written notice of the patient’s rights and responsibilities which included the right to have his or her property and person treated with respect for three of seven sampled patients (Patient 1, 2, and 3). This failure resulted in the patient and/or their representative unaware of the patient rights and responsibilities and their rights are protected and promoted. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information as follows:...The right to privacy, security, and respect of property and person." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be found in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

Be free from abuse CFR(s): 484.50(c)(2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the patient or their representative received written notice of the patient’s rights and responsibilities which included the right to be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property for three of seven sampled patients (Patient 1, 2 and 3). This failure resulted in the patient and/or their representative unaware of the patient rights and responsibilities and their rights are protected and promoted. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they were not given any education or information on abuse from the HHA. CG 3 further stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information as follows:...The right to be free from mental, physical, sexual and/or verbal abuse, neglect, or exploitation." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be found in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

Make complaints to the HHA CFR(s): 484.50(c)(3) Make complaints to the HHA regarding treatment or care that is (or fails to be) furnished, and the lack of respect for property and/or person by anyone who is furnishing services on behalf of the HHA; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the patient or their representative received written notice of the patient’s rights and responsibilities which included make complaints to the Home Health Agency (HHA) regarding treatment or care that is (or fails to be) furnished, and the lack of respect for property and/or person by anyone who is furnishing services on behalf of the HHA for three of seven sampled patients (Patient 1, 2 and 3). This failure resulted in the patient and/or their representative unaware of the patient rights and responsibilities and their rights are protected and promoted. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information as follows:...The right to voice a complaint or concern regarding care or service. The availability of other sources to receive questions and complaints and assist in resolution. Patients will be provided with the California Home Health Agency Hotline number, the hours of operation and the purpose of the hotline to address questions regarding home health, concerns of care or to lodge complaints regarding implementation of advance directive requirements." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the patient or their representative received written notice of the patient’s rights and responsibilities, which included the right to consent or refuse care in advance of and during treatment for four of seven sampled patients (Patient 1, 2, 3, and 4). This failure resulted in the patient and/or their representative unaware of the patient rights and responsibilities and their rights are protected and promoted. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that a consent for the collection of personal medical information and consent to treatment and/or services was in Patient 2's binder but was not signed. CG 2 stated HHA staff did ask them to sign the consents. Patient 2's signed consent for the collection of personal medical information and consent to treatment and/or services was requested from the SC on 1/28/25 at 2:07 p.m. A review of Patient 2's signed consent for the collection of personal medical information and consent to treatment and/or service indicated the consents were signed 9/26/24. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2's clinical records were reviewed. The SC confirmed that Patient 2's start of care date was 10/14/24 but the informed consents were signed 9/26/24. The SC stated that Patient 2 and Patient 2's representative might have put the wrong date. The SC then stated that Patient 2 and Patient 2's representative only signed the informed consents yesterday. The SC further stated that the consent for the collection of personal medical information and consent to treatment and/or service should be signed on the first visit of the patient. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures). Patient 4's signed consent for the collection of personal medical information and consent to treatment and/or services was requested from the SC on 1/28/25 at 2:30 p.m. A review of Patient 4's consent for the collection of personal medical information and consent to treatment and/or service indicated the consent for the collection of personal medical information was signed by Patient 4's representative on 1/3/25 and the consent to treatment and/or service was not signed. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical records were reviewed. The SC confirmed that Patient 4's start of care date was 1/18/18 but the collection of personal medical information was signed by Patient 4's representative on 1/3/25 and the consent to treatment and/or service was not signed. The SC stated the HHA asked patients and their representative to re-sing their consents when the HHA changed their company name. The SC further stated both consents should be signed. During a review of the facility's policy and procedure(P&P) titled, "INFORMED CONSENT/REFUSAL OF TREATMENT", revised 10/2008, the P&P indicated, "Upon admission and throughout the course of care, the patient and family/caregiver will be: ...4. Allowed to refuse all or part of his/her care to the extent permitted by law; the expected consequences of such actions must be explained: A. During the admission visit, the patient or authorized representative will sign the organization’s written consent for care..." A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

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 interview and record review, the Home Health Agency (HHA) failed to ensure the patient or their representative received written notice of the patient’s rights and responsibilities which included the right to receive all services outlined in the plan of care for three out of seven sampled patients (Patient 1, 2 and 3). This failure resulted in the patient and/or their representative to be unaware of the patient rights and responsibilities and that their rights are protected and promoted. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." During a review of the facility's policy and procedure (P&P) titled, "RIGHTS/RESPONSIBILITIES", revised 10/2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency...1. The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information...O. The right to voice complaint or concern regarding care or services. The availability of other sources to receive questions and complaints and assist in resolution. Patients will be provided with the California Home Health Agency Hotline number, the hours of operation and the purpose of the hotline to address questions regarding home health, concerns of care or to lodge complaints regarding implementation of advance directive requirements." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that the only contact information that was provided were for the Staffing Supervisor (SS), the Recruiting Manger, and the Nurse Supervisor. CG 2 further confirmed that they were not provided with the California Home Health Agency Hotline number, its hours of operation, and its purpose. CG 2 stated they would just call the HHA, the referring agency, and inform Patient 2's sister for issues or complaints. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated the contact information in the patient's binder were the only contact information provided to the patient or patient's representative. During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

Have a confidential clinical record CFR(s): 484.50(c)(6) Have a confidential clinical record. Access to or release of patient information and clinical records is permitted in accordance with 45 CFR parts 160 and 164. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the patient or their representative received written notice of the patient’s rights and responsibilities which included the right to have a confidential clinical record and access to or release of patient information and clinical records for three of seven sampled patients (Patient 1, 2, and 3). This failure resulted in the patient and/or their representative to be unaware of the patient rights and responsibilities and that their rights were protected and promoted. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information as follows:...The right to confidentiality of the clinical records maintained by the agency, and be advised of the agencies policies and procedures regarding disclosure of clinical records." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be found in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the patient or their representative received written notice of the patient’s rights and responsibilities which included being advised, orally and in writing, of the extent to which payment for HHA (home health agency) services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, the charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, the charges the individual may have to pay before care is initiated; and any changes in the information provided when they occur. The HHA must advise the patient and representative of these changes as soon as possible, in advance of the next home health visit for three of seven sampled patients (Patient 1, 2, and 3). This failure resulted in the patient and/or their representative to be unaware of the patient rights and responsibilities and that their rights are protected and promoted. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information as follows:...The right to be informed of any changes in patient liability and cost of services." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be found in the binder in the patient's home. A home visit was conducted on 1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the patient or their representative received written notice of the patient’s rights and responsibilities which included proper written notice, in advance of a specific service being furnished, if the HHA (home health agency) believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care for three of seven sampled patients (Patient 1, 2, and 3). This failure resulted in the patient or their representative to be unaware of the patient rights and responsibilities and that their rights are protected and promoted. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

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 interview and record review, the agency failed to ensure the patient or their representative received written notice of the patient’s rights and responsibilities which included being 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 (home health agencies) for three of seven sampled patients (Patient 1, 2, and 3). This failure resulted in the patient or their representative to be unaware of the patient rights and responsibilities and that their rights are protected and promoted. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they were not given any information about who to contact if they had to file a complaint about the HHA. CG 3 confirmed Patient 3’s patient binder did not contain the California Home Health Agency Hotline number, its hours of operation, and its purpose. CG 3 further confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder and there was no contact information listed for the California Home Health Agency Hotline number. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information as follows:...The right to voice a complaint or concern regarding care or service. The availability of other sources to receive questions and complaints and assist in resolution. Patients will be provided with the California Home Health Agency Hotline number, the hours of operation and the purpose of the hotline to address questions regarding home health, concerns of care or to lodge complaints regarding implementation of advance directive requirements." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that the only contact information that was provided were for the SC, the Recruiting Manger, and the Nurse Supervisor. CG 2 further confirmed that they were not provided with the California Home Health Agency Hotline number, its hours of operation, and its purpose. CG 2 stated they would just call the HHA, the referring agency, and inform Patient 2's sister for issues or complaints. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated the contact information in the patient's binder were the only contact information provided to the patient or patient's representative. During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

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 agency failed to ensure the patient or their representative received written notice of the patient’s rights and responsibilities which included being 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, the Agency on Aging, the Center for Independent Living, the Protection and Advocacy Agency, the Aging and Disability Resource Center; and the Quality Improvement Organization for three of seven sampled patients (Patient 1, 2, and 3). This failure resulted in the patient or their representative to be unaware of the patient rights and responsibilities and that their rights are protected and promote A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they were not given any contact information for any Federal or State programs or agencies. CG 3 further confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder and there was no contact information listed for any Federal or State programs or agencies. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

Freedom from discrimination or reprisal CFR(s): 484.50(c)(11) Be free from any discrimination or reprisal for exercising his or her rights or for voicing grievances to the HHA or an outside entity. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the patient or their representative received written notice of the patient’s rights and responsibilities which included the right to be free from any discrimination or reprisal for exercising his or her rights or for voicing grievances to the HHA (home health agency) or an outside entity for three of seven sampled patients (Patient 1, 2, and 3). This failure resulted in the patient or their representative to be unaware of the patient rights and responsibilities and that their rights are protected and promoted. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

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 agency failed to ensure the patient or their representative received written notice of the patient’s rights and responsibilities which included the right to be informed of the right to access auxiliary aids and language service, and how to access these services for three of seven sampled patients (Patient 1, 2, and 3). This failure resulted in the patient or their representative to be unaware of the patient rights and responsibilities and that their rights are protected and promoted. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure (P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

Transfer and discharge CFR(s): 484.50(d) Standard: Transfer and discharge. The patient and representative (if any), have a right to be informed of the HHA's policies for transfer and discharge. The HHA may only transfer or discharge the patient from the HHA if: This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure the patient or their representative received written notice of the patient’s rights and responsibilities which included the right to be informed of the HHA's (home health agency) policies for transfer and discharge for three of seven sampled patients (Patient 1, 2 and 3). This failure resulted in the patient or their representative to be unaware of the patient rights and responsibilities and that their rights are protected and promoted. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated they did not remember receiving any written information about patient/patient's representative rights and responsibilities from the HHA and confirmed there were no written information pertaining to patient/patient's representative rights and responsibilities in Patient 3’s patient binder. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency. Each patient will be an active, informed participant in his/her plan of treatment. To ensure this process, the patient will be empowered with certain rights and responsibilities as described. A patient may designate someone to act as his/her representative. This representative, on behalf of the patient, may exercise any of the rights provided by the policies and procedures established by the organization. To assist with fully understanding patient rights and responsibilities, all policies are available to organization personnel, the patient, and his/her representatives as well as other organizations and the interested public." "The patient will be informed in advance of furnishing care or during the initial evaluation before the initiation of treatment and in writing of his or her rights and information..."The admitting clinician will provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission...The Patient Rights and Responsibilities will be explained and distributed to the patient prior to the initiation of organization services...The patient will be requested to sign the Patient Rights and Responsibilities form. The original form will be kept in the patient's clinical record. A copy will be maintained by the patient...The admitting clinician will document that the patient has received a copy of the Patient Rights and Responsibilities...When the patient's representative signs the Patient Rights and Responsibilities form, an explanation of that relationship must be documented and kept on file in the clinical record." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. The SC further stated, "If it's [patient or patient's representative rights and responsibilities] not there [Patient 2's binder], then it's not provided." During an interview on 1/27/25 at 3:55 p.m. with the Staffing Coordinator (SC) she stated a copy of the signed patient rights form would be in the binder in the patient's home. A home visit was conducted on1/28/25 at 11:58 a.m. to Patient 1's home and accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review with LN 3, Patient 1's admission binder was reviewed. LN 3 confirmed there was no copy of the Patient Rights and Responsibilities in the binder.

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 interview and record review, it was determined the Home Health Agency (HHA) failed to conduct the initial assessment visit within 48 hours of referral (G514); failed complete the comprehensive assessment within 5 calendar days after the start of care (G520); failed to accurately reflect the patient's health status in the comprehensive assessment (G528); failed to include patient's goals in their comprehensive assessment (G530); failed to include the assessment of patient's continuing need for home care in their comprehensive assessments (G532); failed to include patient's discharge plan in their comprehensive assessments (G534); failed to include a review of all medications the patient is currently using in the comprehensive assessment (G536); and, the patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; (G538). The extent and cumulative effect of these systemic practices resulted in the agency's inability to ensure that the patients' received patient-specific comprehensive assessments.

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 home health agency (HHA) failed conduct the initial assessment visit within 48 hours of referral for two out of seven sampled patients (Patient 2 and Patient 4). This failure had the potential for Patient 2 and Patient 4 to not received their immediate care and support needs. 1a. A review of Patient 2's clinical records, the clinical record indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). Patient 2's referral note for Home Health services was requested from the Staffing Coordinator (SC) on 1/28/25 at 10 a.m. A review of the document provided by the SC indicated Patient 2 was referred to the HHA on 9/26/24 for Home Health services. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2's clinical records were reviewed. The SC confirmed that Patient 2's referral to the HHA for Home Health services was 9/26/24 and Patient 2's initial visit was dated 10/14/24 which was 18 days after the referral date. The SC stated she did not know what happened from the time Patient 2 was referred to the HHA until Patient 2 was visited. 1b. A review of Patient 4's clinical records, the clinical record indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures). Patient 4's referral note for Home Health services was requested from the SC on 1/29/25 at 10:12 a.m. A review of the document provided by the SC indicated Patient 4 was referred to the HHA on 1/12/18 for Home Health services. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical records were reviewed. The SC confirmed that Patient 4's referral to the HHA for Home Health services was 1/12/18 and Patient 4's initial visit was dated 1/18/18 which was six days after the referral date. The SC stated those were the only documents she could provide. During a review of the facility's policy and procedure (P&P) titled, "ADMISSION CRITERIA AND PROCEDURE", revised 10/2008, the P&P indicated, "2. The Clinical Supervisor will assign clinical organization personnel to conduct assessments of eligibility for services within 48 hours of acceptance of referral...A. The initial visit must be performed either within 48 hours of the referral..."

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to complete the comprehensive assessment for two out of seven sampled patients (Patient 2 and Patient 7) within five calendar days after the start of care. This failure had the potential for Patient 2 and Patient 7 to not timely receive their health needs and care preferences. A review of Patient 7's clinical records indicated Patient 7 had a start of care date with the HHA on 8/20/24 and was discharged on 9/27/24 with no diagnosis listed. A review of Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", indicated the start of care was 8/20/24 and the initial assessment by a registered nurse was completed on 8/28/24. During a concurrent interview and record review on 1/28/25 at 9:35 a.m. with the SC, Patient 7's clinical records were reviewed. The SC confirmed Patient 7’s initial assessment was completed eight days after the start of care. During a review of the facility's policy and procedure (P&P) titled, "ENTRIES INTO THE CLINICAL RECORD", revised 7/2016, the P&P indicated, "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." A review of the "Electronic Code of Federal Regulations (e-CFR): Title 42—Public Health", section 484.55, titled, "Condition of participation: Comprehensive assessment of patients.", dated 11/9/21, indicated, "(b) Standard: Completion of the comprehensive assessment. (1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care." (https://www.law.cornell.edu/cfr/text/42/484.55) A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's comprehensive assessment titled, "Non-Oasis Start of Care", dated 10/14/24, indicated the Start of Care date was 10/14/24 and the Date Completed section was left blank. The comprehensive assessment was electronically signed by the nurse on 12/18/24 which was almost 2 months after the Start of Care date. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), Patient 2's clinical records were reviewed. The SC confirmed that Patient 2's Start of Care date was 10/14/24 but the comprehensive assessment was only signed by the nurse on 12/18/24. The SC stated, "...that's when it (comprehensive assessment) was done."

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) 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: (1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to accurately reflect two of seven sampled patients' (Patient 2 and Patient 7) health status in its comprehensive assessment. This failure had the potential for Patient 2 and Patient 7 to not receive accurate treatment to their health needs and care preferences. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's comprehensive assessment titled, "Non-Oasis Start of Care", dated 10/14/24, indicated, "Discharge Plans...Discharge when wound(s) healed..." A further review of Patient 2's comprehensive assessment titled, "Non-Oasis Start of Care", dated 10/14/24, integumentary section, indicated Patient 2 had no wound(s) or any skin issues. During an interview on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), the SC stated she would expect the comprehensive assessment to be accurate. A review of Patient 7's clinical records indicated Patient 7 had a start of care date with the HHA on 8/20/24 and was discharged on 9/27/24 with no diagnosis listed. A review of Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", indicated the start of care was 8/20/24 and the initial assessment by a registered nurse was completed on 8/28/24. Information for allergies, diagnosis, medications, vitals signs and immunizations were blank. During a concurrent interview and record review on 1/28/25 at 9:35 a.m. with the SC, Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", was reviewed. The SC confirmed Patient 7’s comprehensive assessment was missing diagnosis, allergies, medications, vital signs and immunization information. The SC stated the information should not have been left blank. During a review of the facility's policy and procedure (P&P) titled, "INITIAL AND COMPREHENSIVE ASSESSMENT", revised 10/2008, the P&P indicated, "An initial patient assessment will be performed and documented in the patient’s clinical record by a registered nurse, physical therapist, or speech therapist on all patients referred. The assessment will be patient-specific and comprehensive to include the patient’s need for home health care and discharge planning." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's comprehensive assessment titled, "Non-Oasis Start of Care", dated 10/14/24, indicated, "Discharge Plans...Discharge when wound(s) healed..." A further review of Patient 2's comprehensive assessment titled, "Non-Oasis Start of Care", dated 10/14/24, integumentary section, indicated Patient 2 had no wound(s) or any skin issues. During an interview on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), the SC stated she would expect the comprehensive assessment to be accurate. A review of Patient 7's clinical records indicated Patient 7 had a start of care date with the HHA on 8/20/24 and was discharged on 9/27/24 with no diagnosis listed. A review of Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", indicated the start of care was 8/20/24 and the initial assessment by a registered nurse was completed on 8/28/24. Information for allergies, diagnosis, medications, vitals signs and immunizations were blank. During a concurrent interview and record review on 1/28/25 at 9:35 a.m. with the SC, Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", was reviewed. The SC confirmed Patient 7’s comprehensive assessment was missing diagnosis, allergies, medications, vital signs and immunization information. The SC stated the information should not have been left blank. During a review of the facility's policy and procedure (P&P) titled, "INITIAL AND COMPREHENSIVE ASSESSMENT", revised 10/2008, the P&P indicated, "An initial patient assessment will be performed and documented in the patient’s clinical record by a registered nurse, physical therapist, or speech therapist on all patients referred. The assessment will be patient-specific and comprehensive to include the patient’s need for home health care and discharge planning."

Strengths, goals, and care preferences CFR(s): 484.55(c)(2) The patient's strengths, goals, and care preferences, including information that may be used to demonstrate the patient's progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the HHA; This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to include patient's goals for three out of seven sampled patients (Patient 2, 3 and 4) in their comprehensive assessment. This failure had the potential for Patient 2, Patient 3, and Patient 4 to not receive their health needs and care preferences, and to not get assessed with their progress towards achievement of their goals. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. A review of Patient 3's comprehensive assessment titled, "Home Health Certification and Plan of Care", dated 1/2/25 to 3/2/25, did not include any patient goals or discharge plan. During a concurrent interview and record review on 1/28/25 at 9:35 a.m. with the SC, Patient 3's clinical record was reviewed. The SC confirmed Patient 3's comprehensive assessment, dated 1/2/25 to 3/2/25, did not include any patient treatment goals or discharge plan. The SC stated the information should not have been left blank. 1a. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's comprehensive assessment titled, "Recertification", dated 12/14/24, did not include any patient treatment goal. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's comprehensive assessment dated 12/14/24 did not include any patient treatment goal. 1b. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures). A review of Patient 4's comprehensive assessment titled, "Recertification", dated 10/12/24, did not include any patient treatment goal. A review of Patient 4's comprehensive assessment titled, "Recertification", dated 12/12/24, did not include any patient treatment goal. During a concurrent interview on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical records were reviewed. The SC confirmed that Patient 4's comprehensive assessments dated 10/12/24 and 12/12/24 did not include any patient treatment goal. A review of the facility's policy and procedure (P&P) titled, "INITIAL AND COMPREHENSIVE ASSESSMENT", revised 10/2008, the P&P indicated, "2. During the initial and comprehensive patient assessments, all baseline data to be used in measuring the patient’s progress toward goals and other relevant information will be documented in the patient’s clinical record..." A review of the facility's P&P titled, "ONGOING ASSESSMENTS", revised 10/2008, the P&P indicated, "4. Based on each reassessment, the plan of treatment—including problems, needs, goals, and outcomes— will be reviewed and revised by the clinician."

Continuing need for home care CFR(s): 484.55(c)(3) The patient's continuing need for home care; This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to include assessment of patient's continuing need for home care for two out of seven sampled patients (Patient 2 and Patient 4) in their comprehensive assessments. This failure had the potential for Patient 2 and Patient 4 to not continuously receive their health needs and care preferences. 1a. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's comprehensive assessment titled, "Recertification", dated 12/14/24, did not include an assessment of patient's continuing need for home care. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's comprehensive assessment dated 12/14/24 did not include an assessment of patient's continuing need for home care. 1b. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures). A review of Patient 4's comprehensive assessment titled, "Recertification", dated 10/12/24, did not include an assessment of patient's continuing need for home care. A review of Patient 4's comprehensive assessment titled, "Recertification", dated 12/12/24, did not include an assessment of patient's continuing need for home care. During a concurrent interview on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical records were reviewed. The SC confirmed that Patient 4's comprehensive assessments dated 10/12/24 and 12/12/24 did not include an assessment of patient's continuing need for home care. A review of the facility's policy and procedure (P&P) titled, "INITIAL AND COMPREHENSIVE ASSESSMENT", revised 10/2008, the P&P indicated, "The assessment will be patient-specific and comprehensive to include the patient’s need for home health care..."

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to include patient's discharge plan for three out of seven sampled patients (Patient 2, Patient 3, and Patient 4) in their comprehensive assessments. This failure had the potential for Patient 2, Patient 3, and Patient 4 to not meet their discharge planning needs and preferences. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. A review of Patient 3's comprehensive assessment titled, "Home Health Certification and Plan of Care", dated 1/2/25 to 3/2/25, did not include any patient goals or discharge plan. During a concurrent interview and record review on 1/28/25 at 9:35 a.m. with the SC, Patient 3's clinical record was reviewed. The SC confirmed that Patient 3's comprehensive assessment, dated 1/2/25 to 3/2/25, did not include any patient treatment goals or discharge plan. The SC stated the information should not have been left blank. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's comprehensive assessment titled, "Recertification", dated 12/14/24, did not include Patient 2's discharge plans. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's comprehensive assessment dated 12/14/24 did not include Patient 2's discharge plans. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures). A review of Patient 4's comprehensive assessment titled, "Recertification", dated 10/12/24, did not include Patient 4's discharge plans. A review of Patient 4's comprehensive assessment titled, "Recertification", dated 12/12/24, did not include Patient 4's discharge plans. During a concurrent interview on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical records were reviewed. The SC confirmed that Patient 4's comprehensive assessments dated 10/12/24 and 12/12/24 did not include Patient 4's discharge plans. A review of the facility's policy and procedure (P&P) titled, "INITIAL AND COMPREHENSIVE ASSESSMENT", revised 10/2008, the P&P indicated, "The assessment will be patient-specific and comprehensive to include the patient’s need for home health care and discharge planning."

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 interview and record review, the home health agency (HHA) failed to include a review of all medications the patient is currently using for two out of seven sampled patients (Patient 2 and Patient 7) in their comprehensive assessment. This failure had the potential for Patient 2 and Patient 7 to experience an unidentified potential medication adverse effect, ineffective drug therapy, significant side effects, drug interactions, duplicate drug therapy, and/or noncompliance with drug therapy. A review of Patient 7's clinical records indicated Patient 7 had a start of care date with the HHA on 8/20/24 and was discharged on 9/27/24 with no diagnosis listed. A review of Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", indicated the start of care was 8/20/24 and the initial assessment by a registered nurse was completed on 8/28/24. Information for allergies, diagnosis, medications, vital signs and immunizations were blank. During a concurrent interview and record review on 1/28/25 at 9:35 a.m. with the SC, Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", was reviewed. The SC confirmed Patient 7’s comprehensive assessment was missing diagnosis, allergies, medications, vital signs and immunization information. The SC stated the information should not have been left blank. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's comprehensive assessment titled, "Recertification", dated 12/14/24, did not include a review of all medications that Patient 2 is currently using. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's comprehensive assessment dated 12/14/24 did not include a review of all medications that Patient 2 is currently using. A review of the facility's policy and procedure (P&P) titled, "INITIAL AND COMPREHENSIVE ASSESSMENT", revised 10/2008, the P&P indicated, "2. During the initial and comprehensive patient assessments, all baseline data to be used in measuring the patient’s progress toward goals and other relevant information will be documented in the patient’s clinical record, including at least the following information, if applicable: ...M. Review of medication history, as applicable to care and service and current medication use, including prescription, over-the-counter medications and herbal medications, and identifying drug interactions, duplicative drug therapy, and noncompliance with therapy."

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to include an assessment on the willingness and ability to provide care, and availability of the patient’s primary caregiver(s), if any, and other available supports for two out of seven sampled patients (Patient 2 and Patient 7) in the comprehensive assessment. This failure had the potential for Patient 2 to not have an available caregiver or support to provide needed care. A review of Patient 7's clinical records indicated Patient 7 had a start of care date with the HHA on 8/20/24 and was discharged on 9/27/24 with no diagnosis listed. A review of Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", indicated the start of care was 8/20/24 and the initial assessment by a registered nurse was completed on 8/28/24. The assessment did not include the names or contact information for Patient 7’s primary caregivers or other available support. During a concurrent interview and record review on 1/28/25 at 2 p.m. with the SC, Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", was reviewed. The SC confirmed Patient 7’s comprehensive assessment was missing information about the primary caregiver. The SC stated she was not aware the information needed to be in the clinical records. A review of the facility's policy and procedure (P&P) titled, "INITIAL AND COMPREHENSIVE ASSESSMENT", revised 10/2008, the P&P indicated, "2. During the initial and comprehensive patient assessments, all baseline data to be used in measuring the patient’s progress toward goals and other relevant information will be documented in the patient’s clinical record, including at least the following information, if applicable: ...N. Patient and family/caregiver support systems and the type of care the family/caregiver is available, capable, and willing to provide...P. Involvement of family/caregiver, neighbors, or other individuals or organizations." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's comprehensive assessment titled, "Recertification", dated 12/14/24, did not include an assessment on the willingness and ability to provide care, and availability of Patient 2's primary caregivers and other available supports. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's comprehensive assessment dated 12/14/24 did not include an assessment on the willingness and ability to provide care, and availability of Patient 2's primary caregivers and other available supports.

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 Home Health Agency (HHA) failed to ensure patients were 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 (G570); failed to ensure the plan of care was updated every 60 days (G572); failed to ensure the individualized plan of care included all pertinent patient diagnoses and all patient medications (G574); failed to ensure drugs, services, and treatments were administered only as ordered by a physician (G580);.......................(G584) failed to ensure the individualized plan of care was reviewed and revised by the physician or allowed practitioner as frequently as the patient's condition or needs required, but no less frequently than once every 60 days, beginning with the start of care date (G588); failed to ensure communication with all physicians involved in the plan of care (G602); failed to ensure patient care was coordinated (G608); failed to ensure that each patient, and his or her caregiver(s), received ongoing education and training regarding the care and services by not providing an admission packet (G610); and failed to ensure medication profiles were accurate and current (G616). The extent and cumulative effect of these systemic practices resulted in the agency's inability to ensure that the patients' nursing needs were coordinated and provided as ordered. This COP was also taken out in the agency's previous Recertification survey on 3/11/22. The agency failed to ensure patients were 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 for two of seven sampled patients (Patient 1 and Patient 6). This failure resulted in patients' needs not being provided.

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 agency failed to ensure each patient received home health services that were written in an individualized plan of care (POC) that identifies patient-specific measurable outcomes and goals, that was 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 and missed visits were communicated to a physician for seven out of seven sampled patients (Patient 1, 5, 6, 2, 4, 3, and 7). This failure had the potential for the seven sampled patients to receive treatments that were not reviewed and approved by a physician. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a review of Patient 3's comprehensive assessment titled, "Home Health Certification and Plan of Care", dated 1/2/25 to 3/2/25, revealed the comprehensive assessment was not signed by a physician. A review of Patient 7's clinical records indicated Patient 7 had a start of care date with the HHA on 8/20/24 and was discharged on 9/27/24 with no diagnosis listed. During a review of Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", indicated the start of care was 8/20/24 and the initial assessment by a registered nurse was completed on 8/28/24. The assessment was not signed by a physician. During a concurrent interview and record review on 1/28/25 at 9:35 a.m. with the SC, Patient 3's and Patient 7’s clinical records were reviewed. The SC confirmed the comprehensive assessment for both Patient 3 and Patient 7 were not signed by a physician. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/14/24, revealed that the POC was not signed by a physician. A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that the POC was not signed by a physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's POCs dated 10/14/24 and 12/14/24 were both not signed by a physician. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures) A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/12/24, revealed that the POC was not signed by a physician. A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed that the POC was not signed by a physician. A further review of the POC also revealed that Patient 4 was planned to have two times a day, five days in a week, skilled nursing visits. A review of Patient 4's clinical records revealed that Patient 4 had two missed visits on 1/17/25 and another two missed visits on 1/21/25. There were no evidence that the missed visits were communicated to Patient 4's physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical record was reviewed. The SC confirmed that Patient 4's POCs dated 10/12/24 and 12/12/24 were both not signed by a physician. The SC also comfirmed that Patient 4 had missed visits on 1/17/25 and 1/21/25. The SC further confirmed that there were no doucmented evidence that the missed visits were communicated to Patient 4's physician. A review of the facility's policy and procedure (P&P) titled, "CARE PLANNING PROCESS", revised 10/2008, the P&P indicated, "8. Clinicians will inform the patient’s physician of any changes that suggest a need to alter the plan of treatment. Changes must be written, dated, and signed by the professional making the changes." During a review of Patient 1's "Home Health Certification and Plan of Care (POC)," for the certification periods 7/16/24 to 10/13/24, 10/14/24 to 12/12/24, and 12/13/24 to 2/10/25 revealed the POCs had not been signed by a physician. During a review of Patient 5's "Home Health Certification and Plan of Care," for the certification periods 6/23/24 to 9/20/24 and11/20/24 to 1/18/25 revealed the POCs had not been signed by a physician. During a review of Patient 6's "Home Health Certification and Plan of Care," for the certification periods 10/17/24 to 12/15/24 and 12/16/24 to 2/13/25 revealed the POCs had not been signed by a physician. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated the Director of Patient Care Service (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." Review of the agency's policy and procedure titled, "Care Planning Process," revised October 2008, indicated, "A written plan of treatment will be established for each patient whose care requires medical orders. A plan of treatment will be approved and signed within 30 working days by the attending physician, dentist, or podiatrist...The plan of treatment will be reviewed and updated by the attending physician, dentist, or podiatrist in consultation with the agency health professional personnel as frequently as the patient’s condition warrants and at least every 62 days."

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the individualized plan of care included all pertinent patient diagnoses and all patient medications for four out of seven sampled patients (Patient 2, Patient 4, Patient 6 and Patient 7). This failure had the potential to negatively affect the quality and safety of the planned patient care. A review of Patient 7's clinical records indicated Patient 7 had a start of care date with the HHA on 8/20/24 and was discharged on 9/27/24 with no diagnosis listed. A review of Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", indicated the start of care was 8/20/24 and the initial assessment by a registered nurse was completed on 8/28/24. Information for allergies, diagnosis, medications, vital signs and immunizations were blank. During a concurrent interview and record review on 1/28/25 at 9:35 a.m. with the SC, Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", was reviewed. The SC confirmed Patient 7’s comprehensive assessment was missing diagnosis, allergies, medications, vital signs and immunization information. The SC stated the information should not have been left blank. During a review of Patient 6's "Home Health Certification and Plan of Care," for the certification periods 10/17/24 to 12/15/24 and 12/16/24 to 2/13/25 revealed no documentation of Patient 6's diagnoses. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." Review of the agency's policy and procedure titled, "Care Planning Process " revised October 2008, indicated "The clinical plan of treatment includes, but is not limited to, the following pertinent information: pertinent diagnoses..." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/14/24, revealed that the POC was not signed by a physician. A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that the POC was not signed by a physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's POCs dated 10/14/24 and 12/14/24 were both not signed by a physician. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures) A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/12/24, revealed that the POC was not signed by a physician. A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed that the POC was not signed by a physician. A review of Patient 4's clinical records revealed that Patient 4 had two missed visits on 1/17/25 and another two missed visits on 1/21/25. There was no evidence that the missed visits were communicated to Patient 4's physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical record was reviewed. The SC confirmed that Patient 4's POCs dated 10/12/24 and 12/12/24 were both not signed by a physician. The SC also confirmed that Patient 4 had missed visits on 1/17/25 and 1/21/25. The SC further confirmed that there were no documented evidence that the missed visits were communicated to Patient 4's physician. A review of the facility's policy and procedure (P&P) titled, "CARE PLANNING PROCESS", revised 10/2008, the P&P indicated, "A written plan of treatment will be established for each patient whose care requires medical orders. A plan of treatment will be approved and signed within 30 working days by the attending physician, dentist, or podiatrist...The plan of treatment will be reviewed and updated by the attending physician, dentist, or podiatrist in consultation with the agency health professional personnel as frequently as the patient’s condition warrants and at least every 62 days...8. Clinicians will inform the patient’s physician of any changes that suggest a need to alter the plan of treatment. Changes must be written, dated, and signed by the professional making the changes."

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the individualized plan of care included all patient care orders, including verbal orders, for one out of seven sampled patients (Patient 2). This failure had the potential to negatively affect the quality and safety of the planned patient care. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with Licensed Nurse (LN) 2, Patient 2's patient binder was reviewed. LN 2 confirmed that there was a nurses note, dated 11/6/24, which indicated, "Verbal order obtained for [name of doctor] Lisinopril [high blood pressure medication] decrease to 5 mg [milligrams- unit of measurement] daily, hold Lisinopril if Systolic [higher number in the blood pressure reading] < [less than] 110 & diastolic [lower number in the blood pressure reading] < 70." A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that the POC did not included the verbal order regarding Patient 2's Lisinopril medication. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's POC dated 12/14/24 did not included the verbal order regarding Patient 2's Lisinopril medication. A review of the facility's policy and procedure (P&P) titled, "CARE PLANNING PROCESS", revised 10/2008, the P&P indicated, "4. The plan of treatment will be based upon the physician's (or other authorized licensed independent practitioner’s) orders and will encompass the equipment, supplies, and services required to meet the patient’s needs...7. Changes in the plan of treatment will be noted with the following documentation: ...E. Verbal orders"

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 agency failed to ensure drugs, services, and treatments were administered only as ordered by a physician or allowed practitioner for seven out of seven sampled patients (Patient 1, 2, 3, 4, 5, 6, and 7). This failure resulted in the agency's inability to ensure the patients' nursing needs were provided as ordered. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. A review of Patient 7's clinical records indicated Patient 7 had a start of care date with the HHA on 8/20/24 and was discharged on 9/27/24 with no diagnosis listed. During a review of Patient 3's comprehensive assessment titled, "Home Health Certification and Plan of Care", dated 1/2/25 to 3/2/25, revealed the comprehensive assessment was not signed by a physician. During a review of Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", indicated the start of care was 8/20/24 and the initial assessment by a registered nurse was completed on 8/28/24. The assessment was not signed by a physician. During a concurrent interview and record review on 1/28/25 at 9:35 a.m. with the SC, Patient 3's and Patient 7’s clinical records were reviewed. The SC confirmed the comprehensive assessments for both Patient 3 and Patient 7 were not signed by a physician. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/14/24, revealed that the POC was not signed by a physician. A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that the POC was not signed by a physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's POCs dated 10/14/24 and 12/14/24 were both not signed by a physician. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures) A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/12/24, revealed that the POC was not signed by a physician. A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed that the POC was not signed by a physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical record was reviewed. The SC confirmed that Patient 4's POCs dated 10/12/24 and 12/12/24 were both not signed by a physician. A review of the facility's policy and procedure (P&P) titled, "CARE PLANNING PROCESS", revised 10/2008, the P&P indicated, "A written plan of treatment will be established for each patient whose care requires medical orders. A plan of treatment will be approved and signed within 30 working days by the attending physician, dentist, or podiatrist...The plan of treatment will be reviewed and updated by the attending physician, dentist, or podiatrist in consultation with the agency health professional personnel as frequently as the patient’s condition warrants and at least every 62 days." During a review of Patient 1's "Home Health Certification and Plan of Care (POC)," for the certification periods 7/16/24 to 10/13/24, 10/14/24 to 12/12/24, and 12/13/24 to 2/10/25 revealed the POCs had not been signed by a physician. During a review of Patient 5's "Home Health Certification and Plan of Care," for the certification periods 6/23/24 to 9/20/24 and11/20/24 to 1/18/25 revealed the POCs had not been signed by a physician. During a review of Patient 6's "Home Health Certification and Plan of Care," for the certification periods 10/17/24 to 12/15/24 and 12/16/24 to 2/13/25 revealed the POCs had not been signed by a physician. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated the Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all times. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." Review of the agency's policy and procedure titled, "Care Planning Process," revised October 2008, indicated, "A written plan of treatment will be established for each patient whose care requires medical orders. A plan of treatment will be approved and signed within 30 working days by the attending physician, dentist, or podiatrist...The plan of treatment will be reviewed and updated by the attending physician, dentist, or podiatrist in consultation with the agency health professional personnel as frequently as the patient’s condition warrants and at least every 62 days."

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure all verbal order(s) were authenticated and dated by the physician or allowed practitioner in accordance with applicable state laws and regulations and the HHA’s internal policies for one out of seven sampled patients (Patient 2). This failure resulted in the agency's inability to ensure that the patients' nursing needs were coordinated and provided as ordered by a physician. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with Licensed Nurse (LN) 2, Patient 2's patient binder was reviewed. LN 2 confirmed that there was a nurses note, dated 11/6/24, which indicated, "Verbal order obtained for [name of doctor] Lisinopril [high blood pressure medication] decrease to 5 mg [milligrams- unit of measurement] daily, hold Lisinopril if Systolic [higher number in the blood pressure reading] < [less than] 110 & diastolic [lower number in the blood pressure reading] < 70." A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that the POC did not included the verbal order regarding Patient 2's Lisinopril medication. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's clinical record did not indicate a verbal order for Lisinopril signed and dated by a physician. A review of the facility's policy and procedure (P&P) titled, "CONTENTS OF THE CLINICAL RECORD", revised 7/2016, indicated, "1. The following information will be available in the clinical record, as applicable to care and services provided: ...G. Legible, complete, and individualized diagnostic and therapeutic orders authenticated within the time frame defined by the organization, or according to law and regulation." A review of the "Electronic California Code of Regulations: Title 22— Social Security", section 74701, titled, "Orders for Medication and Treatment", amended 10/8/97, indicated, "(a) No medication or treatment shall be given except on signed order of a person lawfully authorized to give such order. Such order may be given by telephone and shall be signed by the patient's attending physician, dentist, podiatrist, or other licensed and legally authorized practitioner within his or her scope of practice within 30 working days." (https://www.law.cornell.edu/regulations/california/22-CCR-74701)

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the individualized plan of care (POC) was reviewed and revised by the physician or allowed practitioner who is responsible for the home health POC and the HHA (home health agency) as frequently as the patient's condition or needs required, but no less frequently than once every 60 days, beginning with the start of care date for seven out of seven sampled patients (Patient 1, 2, 3, 4, 5, 6, and 7). This failure resulted in the agency's inability to ensure that the patients' nursing needs were coordinated and provided as ordered. During a review of Patient 1's "Home Health Certification and Plan of Care (POC)," for the certification periods 7/16/24 to 10/13/24, 10/14/24 to 12/12/24, and 12/13/24 to 2/10/25 revealed the POCs had not been signed by a physician. During a review of Patient 5's "Home Health Certification and Plan of Care," for the certification periods 6/23/24 to 9/20/24 and11/20/24 to 1/18/25 revealed the POCs had not been signed by a physician. During a review of Patient 6's "Home Health Certification and Plan of Care," for the certification periods 10/17/24 to 12/15/24 and 12/16/24 to 2/13/25 revealed the POCs had not been signed by a physician. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m. with the SC, she stated the Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." Review of the agency's policy and procedure titled, " Care Planning Process," revised October 2008, indicated, "A written plan of treatment will be established for each patient whose care requires medical orders. A plan of treatment will be approved and signed within 30 working days by the attending physician, dentist, or podiatrist...The plan of treatment will be reviewed and updated by the attending physician, dentist, or podiatrist in consultation with the agency health professional personnel as frequently as the patient’s condition warrants and at least every 62 days." Review of the agency's policy and procedure titled, "Physican Participation in the Plan of Treatment," revised October 2008, indicated, "A physician will direct the care of every home health patient that requires medical orders admitted for service. The attending physician will certify that medical and skilled services provided by the organization are medically required for the patient. The attending physician will participate in the care planning process by reviewing and revising therapeutic and diagnostic orders. The care will be provided in compliance with his/her therapeutic and diagnostic orders and accepted standards and practice." "The attending physician's recertification will be obtained in intervals of at least every 62 days when the patient’s plan of treatment is reviewed, and more often, if warranted." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that the POC was not signed by a physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's POCs dated 12/14/24 was both not signed by a physician. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures) A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/12/24, revealed that the POC was not signed by a physician. A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed that the POC was not signed by a physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical record was reviewed. The SC confirmed that Patient 4's POCs dated 10/12/24 and 12/12/24 were both not signed by a physician. A review of the facility's policy and procedure (P&P) titled, "CARE PLANNING PROCESS", revised 10/2008, the P&P indicated, "A written plan of treatment will be established for each patient whose care requires medical orders. A plan of treatment will be approved and signed within 30 working days by the attending physician, dentist, or podiatrist...The plan of treatment will be reviewed and updated by the attending physician, dentist, or podiatrist in consultation with the agency health professional personnel as frequently as the patient’s condition warrants and at least every 62 days." A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. A review of Patient 7's clinical records indicated Patient 7 had a start of care date with the HHA on 8/20/24 and was discharged on 9/27/24 with no diagnosis listed. During a review of Patient 3's comprehensive assessment titled, "Home Health Certification and Plan of Care", dated 1/2/25 to 3/2/25, revealed the comprehensive assessment was not signed by a physician. During a review of Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", indicated the start of care was 8/20/24 and the initial assessment by a registered nurse was completed on 8/28/24. The assessment was not signed by a physician. During a concurrent interview and record review on 1/28/25 at 9:35 a.m. with the SC, Patient 3's and Patient 7’s clinical records were reviewed. The SC confirmed the comprehensive assessments for both Patient 3 and Patient 7 were not signed by a physician. During a review of Patient 1's "Home Health Certification and Plan of Care (POC)," for the certification periods 7/16/24 to 10/13/24, 10/14/24 to 12/12/24, and 12/13/24 to 2/10/25 revealed the POCs had not been signed by a physician. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that the POC was not signed by a physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's POCs dated 12/14/24 was both not signed by a physician. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a review of Patient 3's comprehensive assessment titled, "Home Health Certification and Plan of Care", dated 1/2/25 to 3/2/25, revealed the comprehensive assessment was not signed by a physician. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures) A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/12/24, revealed that the POC was not signed by a physician. A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed that the POC was not signed by a physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical record was reviewed. The SC confirmed that Patient 4's POCs dated 10/12/24 and 12/12/24 were both not signed by a physician. During a review of Patient 5's "Home Health Certification and Plan of Care," for the certification periods 6/23/24 to 9/20/24 and11/20/24 to 1/18/25 revealed the POCs had not been signed by a physician. During a review of Patient 6's "Home Health Certification and Plan of Care," for the certification periods 10/17/24 to 12/15/24 and 12/16/24 to 2/13/25 revealed the POCs had not been signed by a physician. A review of Patient 7's clinical records indicated Patient 7 had a start of care date with the HHA on 8/20/24 and was discharged on 9/27/24 with no diagnosis listed. During a review of Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", indicated the start of care was 8/20/24 and the initial assessment by a registered nurse was completed on 8/28/24. The assessment was not signed by a physician. During a concurrent interview and record review on 1/28/25 at 9:35 a.m. with the SC, Patient 3's and Patient 7’s clinical records were reviewed. The SC confirmed the comprehensive assessments for both Patient 3 and Patient 7 were not signed by a physician. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m. with the SC, she stated the Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." Review of the agency's policy and procedure titled, " Care Planning Process," revised October 2008, indicated, "A written plan of treatment will be established for each patient whose care requires medical orders. A plan of treatment will be approved and signed within 30 working days by the attending physician, dentist, or podiatrist...The plan of treatment will be reviewed and updated by the attending physician, dentist, or podiatrist in consultation with the agency health professional personnel as frequently as the patient’s condition warrants and at least every 62 days." Review of the agency's policy and procedure titled, "Physician Participation in the Plan of Treatment," revised October 2008, indicated, "A physician will direct the care of every home health patient that requires medical orders admitted for service. The attending physician will certify that medical and skilled services provided by the organization are medically required for the patient. The attending physician will participate in the care planning process by reviewing and revising therapeutic and diagnostic orders. The care will be provided in compliance with his/her therapeutic and diagnostic orders and accepted standards and practice." "The attending physician's recertification will be obtained in intervals of at least every 62 days when the patient’s plan of treatment is reviewed, and more often, if warranted."

Communication with all physicians CFR(s): 484.60(d)(1) Standard: Coordination of Care. The HHA must: (1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure communication with all physicians or allowed practitioners involved in the plan of care for five out of seven sampled patients (Patient 1, 5, 6, 2, and 4). This failure had the potential for Patients 1, 2, 4, 5, and 6 to receive treatments that were not reviewed and approved by a physician. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that the POC was not signed by a physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's POCs dated 12/14/24 was both not signed by a physician. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures) A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/12/24, revealed that the POC was not signed by a physician. A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed that the POC was not signed by a physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical record was reviewed. The SC confirmed that Patient 4's POCs dated 10/12/24 and 12/12/24 were both not signed by a physician. A review of the facility's policy and procedure (P&P) titled, "CARE PLANNING PROCESS", revised 10/2008, the P&P indicated, "A written plan of treatment will be established for each patient whose care requires medical orders. A plan of treatment will be approved and signed within 30 working days by the attending physician, dentist, or podiatrist...The plan of treatment will be reviewed and updated by the attending physician, dentist, or podiatrist in consultation with the agency health professional personnel as frequently as the patient’s condition warrants and at least every 62 days." During a review of Patient 1's "Home Health Certification and Plan of Care (POC)," for the certification periods 7/16/24 to 10/13/24, 10/14/24 to 12/12/24, and 12/13/24 to 2/10/25 revealed the POCs had not been signed by a physician. During a review of Patient 5's "Home Health Certification and Plan of Care," for the certification periods 6/23/24 to 9/20/24 and11/20/24 to 1/18/25 revealed the POCs had not been signed by a physician. During a review of Patient 6's "Home Health Certification and Plan of Care," for the certification periods 10/17/24 to 12/15/24 and 12/16/24 to 2/13/25 revealed the POCs had not been signed by a physician. There was no documentation the agency communicated with the physician, who initiated home health care and was responsible for the ongoing plan of care, and developed and implemented a coordinated plan of care. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated the Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." Review of the agency's policy and procedure titled, " Care Planning Process," revised October 2008, indicated, "A written plan of treatment will be established for each patient whose care requires medical orders. A plan of treatment will be approved and signed within 30 working days by the attending physician, dentist, or podiatrist...The plan of treatment will be reviewed and updated by the attending physician, dentist, or podiatrist in consultation with the agency health professional personnel as frequently as the patient’s condition warrants and at least every 62 days."

Integrate all orders CFR(s): 484.60(d)(2) Integrate orders from all physicians or allowed practitioners involved in the plan of care to assure the coordination of all services and interventions provided to the patient. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure integration of orders from all physicians or allowed practitioners involved in the plan of care for one out of seven sampled patients (Patient 2). This failure had the potential to negatively affect the coordination of all services and interventions provided to the patient. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with Licensed Nurse (LN) 2, Patient 2's patient binder was reviewed. LN 2 confirmed that there was a nurses note, dated 11/6/24, which indicated, "Verbal order obtained for [name of doctor] Lisinopril [high blood pressure medication] decrease to 5 mg [milligrams- unit of measurement] daily, hold Lisinopril if Systolic [higher number in the blood pressure reading] < [less than] 110 & diastolic [lower number in the blood pressure reading] < 70." A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that the POC did not included the verbal order regarding Patient 2's Lisinopril medication. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's POC dated 12/14/24 did not included the verbal order regarding Patient 2's Lisinopril medication. A review of the facility's policy and procedure (P&P) titled, "CARE PLANNING PROCESS", revised 10/2008, the P&P indicated, "4. The plan of treatment will be based upon the physician's (or other authorized licensed independent practitioner’s) orders and will encompass the equipment, supplies, and services required to meet the patient’s needs...7. Changes in the plan of treatment will be noted with the following documentation: ...E. Verbal orders"

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 agency failed to ensure patient care was coordinated when there was no documented evidence in patients' clinical records that care coordination occurred for five of seven sampled patients (Patient 1, 2, 4, 5, and 6). This failure had the potential to cause lack of coordination of services and potentially omit or duplicate services delivered to patients. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's clinical records did not indicate any documentation that care was coordinated among the nursing staff, the clinical manager (DPCS), the patients and/or their caregivers. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures) A review of Patient 4's clinical records did not indicate any documentation that care was coordinated among the nursing staff, the clinical manager (DPCS), the patients and/or their caregivers. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2 and Patient 4's clinical record were reviewed. The SC confirmed that there was no documented evidence that care was coordinated among the nursing staff, the clinical manager (DPCS), the patients and/or their caregivers A review of the agency's policy and procedure (P&P) titled, "Care Coordination," revised October 2008 indicated, "Written evidence of care coordination will be recorded during the case conference and repeated in skilled nursing visit reports in the patient's clinical records... A registered nurse will be assigned to patients receiving skilled nursing ... Care coordination will include ... Planned face-to-face conferences ... Timely documentation of coordination of care activities ...Appropriate involvement of the patient and caregivers. During a review of Patient 1, Patient 5 and Patient 6's clinical records, there was no documentation that care was coordinated among the nursing staff, the clinical manager (Directo of Patient Care Services-DPCS), the patients and/or their caregivers. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated DPCS 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. A review of the agency's P&P titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." A review of the agency's policy and procedure (P&P) titled, "Care Coordination," revised October 2008 indicated, "Written evidence of care coordination will be recorded during the case conference and repeated in skilled nursing visit reports in the patient's clinical records... A registered nurse will be assigned to patients receiving skilled nursing ... Care coordination will include ... Planned face-to-face conferences ... Timely documentation of coordination of care activities ...Appropriate involvement of the patient and caregivers."

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 agency failed to ensure that each patient, and his or her caregiver(s), received ongoing education and training provided by the HHA (Home Health Agency) regarding the care and services by not providing an admission packet, upon admission, for two of seven sampled patients (Patient 2, and Patient 3). This failure had the potential for Patient 2, and Patient 3' s care needs to not be identified or met. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 11:45 a.m., with CG 3, Patient 3’s patient binder was reviewed. CG 3 stated he did not remember receiving any written information about patient/patient's representative rights and responsibilities nor did he receive any education or training on abuse, infection control or what to do if Patient 3 had a change in condition from the HHA. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no written notice of patient/patient's representative rights and responsibilities nor were there any information on abuse, infection control, or what to do if there was a change in condition in Patient 3's binder. During an interview on 1/28/25 at 2 p.m. with the SC, the SC stated any documents the patient or patient’s representative were given should be in the patient’s binder. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with Licensed Nurse (LN) 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities, and education and training regarding patient care and services in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written notice of patient/patient's representative rights and responsibilities, and and education and training regarding patient care and services in Patient 2's binder and stated they did not sign any written patient/patient's representative rights and responsibilities from the HHA. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided. During a concurrent interview and record review on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), a copy of the agency's admission packet was requested. The SC provided the surveyor a white binder, indicating it was a sample of the agency's admission packet. The sample admission packet included paperwork like a blank medication list, a blank plan of care (POC) and a blank diabetic log. The SC was asked if the agency had any other admission packet, that was provided to patients or their caregivers, that included information like, hours during which care and service are available, safety information, infection control information, the agency's complaint/grievance process, information on Advance Directives or notice of patient rights, she indicated no. A review of the agency's policy and procedure titled, "Admission Criteria and Procedure," revised October 2208, indicated, "If eligibility criteria is met, the patient and family/caregiver will be provided with an organization brochure and various educational materials providing sufficient information on: A. Nature and goals of care and service B. Hours during which care and service are available C. Access to care after hours D. Care costs, if any, to be paid by the patient E. Organization mission, objectives, and the scope of care provided both directly and through contractual agreement F. Safety information G. Infection control information H. Emergency management plans I. Available community resources J. Complaint/grievance process K. Advance Directives L. Other organization personnel involved in care M. Mechanism for notifying the patient and/or family/caregiver of changes in care and any related liability for payment as a result of those changes N. Notice of privacy practices"

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to provide the patient and caregiver with a copy of written plan of care (POC) for one out of seven sampled patients (Patient 2). This failure had the potential for Patient 2 and/or Patient 2's caregiver to not be aware of patient 2's plan of care. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with Licensed Nurse (LN) 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written POC in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written POC in Patient 2's binder and stated that they were not provided with Patient 2's POC. During an interview on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), the SC stated whatever documents placed in the patient's binder are the only papers provided to the patient. The SC further stated that Patient 2's POC was not signed yet by his physician so they have not provided a copy to Patient 2. A review of the facility's policy and procedure (P&P) titled, "CARE PLANNING PROCESS", revised 10/2008, the P&P indicated, "A written plan of treatment will be established for each patient whose care requires medical orders...The patient and family/caregiver will participate in decisions regarding the plan of treatment whenever possible. The care planning process will be documented on the plan of treatment, individualized discipline-specific care plans (if applicable), clinical notes, medication profiles, care conference/summary forms, and discharge/clinical summaries..."

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to provide the patient and caregiver with a copy of written instructions outlining frequency of visits by HHA personnel and personnel acting on behalf of the HHA for two out of seven sampled patients (Patient 2 and Patient 3). This failure had the potential for Patient 2, Patient 3 and/or their caregiver to not be aware of the patients plan of care. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. During a concurrent interview and record review on 1/28/25, during a home visit at 12 p.m., with LN 4, Patient 3's patient binder was reviewed. LN 4 confirmed there were no calendars or visit schedules for Patient 3 in his binder. During a review of the agency's policy and procedure(P&P) titled, "Rights/Responsibilities," revised October 2008, the P&P indicated, "Each patient has the right to be informed of his or her rights and to exercise his or her rights as a patient of the agency…The right to be advised in advance of the disciplines that will furnish care and the frequency of visits proposed to be furnished…" A review of the facility's P&P titled, "CARE PLANNING PROCESS", revised 10/2008, the P&P indicated, "A written plan of treatment will be established for each patient whose care requires medical orders...The patient and family/caregiver will participate in decisions regarding the plan of treatment whenever possible. The care planning process will be documented on the plan of treatment, individualized discipline-specific care plans (if applicable), clinical notes, medication profiles, care conference/summary forms, and discharge/clinical summaries...The clinical plan of treatment includes, but is not limited to, the following pertinent information: ...frequency of services and visits, goals and interventions appropriate to each discipline...Documents include plan of treatment (485) and plans of care (all disciplines)." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with Licensed Nurse (LN) 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written instructions outlining frequency of visits by HHA personnel and personnel acting on behalf of the HHA in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there were no written instructions outlining frequency of visits by HHA personnel and personnel acting on behalf of the HHA in Patient 2's binder and stated that they were not provided with Patient 2's POC. During an interview on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), the SC stated whatever documents placed in the patient's binder are the only papers provided to the patient. The SC further stated that Patient 2's POC was not signed yet by his physician so they have not provided a copy to Patient 2.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to provide the patient and caregiver with a copy of written instructions outlining patient medication schedule/instructions and which medications will be administered by home health agency (HHA) personnel and personnel acting on behalf of the HHA, and ensure medication profiles were accurate and medications in the home were current for two out of seven sampled patients (Patient 1 and Patient 2). This failure had the potential for Patient 1 to experience an unidentified potential medication adverse effect, ineffective drug therapy, significant side effects, drug interactions, duplicate drug therapy, and/or noncompliance with drug therapy and for Patient 2 and/or Patient 2's caregiver to not be aware of patient 2's plan of care. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with LN 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written instructions outlining patient medication schedule/instructions and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with CG 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there was no written instructions outlining patient medication schedule/instructions and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA in Patient 2's binder and stated that they were not provided with Patient 2's POC. During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC stated whatever documents placed in the patient's binder are the only papers provided to the patient. The SC further stated that Patient 2's POC was not signed yet by his physician so they have not provided a copy to Patient 2. A review of the facility's policy and procedure (P&P) titled, "CARE PLANNING PROCESS", revised 10/2008, the P&P indicated, "A written plan of treatment will be established for each patient whose care requires medical orders...The patient and family/caregiver will participate in decisions regarding the plan of treatment whenever possible. The care planning process will be documented on the plan of treatment, individualized discipline-specific care plans (if applicable), clinical notes, medication profiles, care conference/summary forms, and discharge/clinical summaries...The clinical plan of treatment includes, but is not limited to, the following pertinent information: ...medications, treatments...Documents include plan of treatment (485) and plans of care (all disciplines).." A home visit was conducted to Patient 1's residence on 1/28/25 at 11:48 a.m. accompanied by Licensed Nurse (LN) 3. During a concurrent interview and record review on 1/28/25 at 11:48 a.m., with one of Patient 1's caregivers (CG) 1, Patient 1's current "Medication Profile," provided by agency's Staffing Coordinator (SC) on 1/27/25 at 2:38 p.m., was compared to the medication profile in Patient 1's residence. CG 1 stated Patient 1 was receiving Risperidone (antipsychotic) 3 mg (milligrams) twice a day and 1 mg at bedtime and Depakote (used to treat seizures and psychiatric conditions) 500 mg twice a day. Patient 1's " Medication Profile" indicated Patient 1 was taking Risperidone 4 mg once a day and there was no documentation of the medication Depakote. During a review of Patient 1's "Medication Profile," provided by agency's Staffing Supervisor on 1/27/25 at 2:38 p.m., contained the following medications that Patient 1 was no longer receiving: Prozac (used to treat depression, obsessive compulsive disorders and disorders) and Trazadone (treat depression). During a review of the agency's policy and procedure titled, "Medication Profile," revised October 2008, indicated, "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."

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to provide the patient and caregiver with a copy of written instructions outlining treatments to be administered by HHA personnel and personnel acting on behalf of the HHA for one out of seven sampled patients (Patient 2). This failure had the potential for Patient 2 and/or Patient 2's caregiver to not be aware of patient 2's plan of care. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). During a concurrent interview and record review on 1/28/25, during a home visit at 11:20 a.m., with Licensed Nurse (LN) 2, Patient 2's patient binder was reviewed. LN 2 stated all documents given to the patient are placed in the patient binder. LN 2 confirmed that there was no written instructions outlining treatments to be administered by HHA personnel and personnel acting on behalf of the HHA in Patient 2's binder. During a concurrent interview and record review on 1/28/25, during a home visit at 11:30 a.m., with caregiver (CG) 2, Patient 2's patient binder was reviewed. CG 2 confirmed that there were no written instructions outlining treatments to be administered by HHA personnel and personnel acting on behalf of the HHA in Patient 2's binder and stated that they were not provided with Patient 2's POC. During an interview on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), the SC stated whatever documents placed in the patient's binder are the only papers provided to the patient. The SC further stated that Patient 2's POC was not signed yet by his physician so they have not provided a copy to Patient 2. A review of the facility's policy and procedure (P&P) titled, "CARE PLANNING PROCESS", revised 10/2008, the P&P indicated, "A written plan of treatment will be established for each patient whose care requires medical orders...The patient and family/caregiver will participate in decisions regarding the plan of treatment whenever possible. The care planning process will be documented on the plan of treatment, individualized discipline-specific care plans (if applicable), clinical notes, medication profiles, care conference/summary forms, and discharge/clinical summaries...The clinical plan of treatment includes, but is not limited to, the following pertinent information: ...treatments, safety measures, instructions to patient and family...Documents include plan of treatment (485) and plans of care (all disciplines)..."

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on interview and record review, it was determined the Home Health Agency (HHA) failed to have a program that showed measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care (G642); failed to take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained (G656) and failed to ensure the governing body had an ongoing program for quality improvement and patient safety is defined, implemented, and maintained (G660). The extent and cumulative effect of these systemic practices resulted in the Home Health Agency (HHA) not developing, implementing, evaluating, and maintaining an effective, ongoing QAPI program.

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 email correspondence and record review the Home Health Agency (HHA), failed to present their Quality Assessment and Performance Improvement (QAPI) program was at least 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. 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. Furthermore, The HHA selects the indicators that it will utilize in its QAPI program based upon identified adverse or negative patient outcomes or agency processes that the HHA wishes to monitor and measure. Each indicator must be measurable through data to evaluate any HHA change in procedure, policy or intervention. The HHA QAPI program must include procedures for measurement and analysis of indicators and address the frequency with which such measurement and analysis will occur. Per §484.70(b) the HHA must maintain a coordinated agency-wide program for the surveillance, investigation, identification, prevention, control and investigation of infectious and communicable diseases as an integral part of the QAPI program. On an email correspondence with the Administrator, dated 1/28/25 at 3:35 p.m., the Administrator failed to present their QAPI program scope to the surveyor.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on email correspondence and record review the Home Health Agency’s (HHA) governing body failed to ensure that an ongoing program for quality improvement and patient safety is defined, implemented, and maintained. That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness and clear expectations for patient safety are established, implemented, and maintained and appropriately address any findings of fraud or waste. The governing body must assume overall responsibility for ensuring that the Quality Assessment and Performance Improvement (QAPI) program reflects the complexity of the HHA and its services, involves all services (including those provided under contract or arrangement), focuses on indicators related to improved outcomes, and takes actions that address the HHA's performance across the spectrum of care. Additionally, the HHA’s governing body must appropriately address any findings of fraud or waste in order to assure that resources are appropriately used for patient care activities and that patients are receiving the right care to meet their needs (82 FR 4504, 4510, 4561 (Jan. 13, 2017)). If the HHA identifies or otherwise learns of an action by an HHA employee, contractor or responsible or relevant physician or allowed practitioner that may be illegal, the HHA should report the action to the appropriate authorities in accordance with applicable law. On an email correspondence with the Administrator, dated 1/28/25 at 3:35 p.m., the Administrator failed to present their QAPI program, and show to the surveyor their meeting minutes or other evidence of how the governing body exercises ongoing oversight of and accountability for the HHA’s QAPI program.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on interview and clinical record review, the agency failed to maintain and document the infection control program which had as its goal the prevention and control of infections as evidenced by: The agency failed to implement and maintain the infection control program which included surveillance, identification, prevention, control, and investigation of infections. Cross reference to G682, G684, and G686. The cumulative effect of these systemic practices resulted in the failure of the agency to deliver statutorily mandated compliance with provision of infection control program to prevent the spread of infections.

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 interview and record review, the agency failed to follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections to 7 sampled patients. This failure may cause possible transmission of infections to the patients During an interview on 1/29/25 at 12:15 p.m., with Licensed Nurse 2 (LN2), she stated, infection control in-service was done on zoom meeting and did not have an in person or annual training about infection prevention (IP). LN 2 stated further she was not aware of any type of surveillance for IP done by the HHA and were updated only by the Staffing Coordinator (SC) about IP over the phone as needed. LN 2 acknowledged, she conducted home visits and had requested several times to provide them with antibacterial wipes to sanitized medical equipment and work area before and after visits, to prevent possible transmission of infection to the patients but the HHA had not provided their request yet. LN 2 further acknowledge, she did not remember getting trained by the HHA on how to properly don and doff Personal Protective Equipment (PPE, used to prevent or minimize exposure to hazards) but relied on what she has learned from her other job. During an interview on 1/29/25 at 12:32 p.m., with Licensed Nurse 4 (LN 4), LN 4 stated, she completed her new employee trainings online that included IP, and all trainings were done online/zoom meetings, and LN 4 is not aware if they have an IP resource and who was the IP resource for HHA. LN 4 mentioned, the HHA staff update LNs over the phone for IP information as needed, but there was no annual IP training and IP surveillance implemented by the HHA. LN 4 confirmed, she conducted home visits for disabled and diabetic patients and wished antibacterial wipes were provided to disinfect work area and medical equipment to promote infection control. During an interview on 1/29/25 at 1:31 p.m., with Staffing Coordinator (SC), the SC stated, she was not a nurse and unable to answer clinical questions, and the Director of Patient Care Services (DPCS) was not available to answer questions as well. During a review of the facility’s policy and procedure, titled “Infection Control Plan,” revised July 2016, indicated, …”1. Establish the mechanisms by which the organization will address surveillance, prevention, identification, control and reporting of infections, utilizing current scientific methods and epidemiologic principles 2. Guide organization personnel in the care and services they provide in relation to infection control practice 3. Educate organization personnel, patients, family/caregivers, and others in the prevention and control of infections 4. Provide for surveillance systems to track the occurrence and transmission of infections… committed to reducing the risk of acquisition and transmission of health care associated infections (HAIs). Recognized prevention and control mechanisms will be implemented for planning, surveillance, identification, prevention/controls, and reporting procedures. To determine the effectiveness of the infection control plan,… will measure, assess, improve, and redesign (as appropriate) the surveillance, identification, prevention, and control function annually through its performance improvement program…”

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to promote an infection control surveillance program to prevent possible transmission of infections for 7 sampled patients. This failure had the potential to overlook causative factors of infection, track patterns and trends of infections related to lack of surveillance. During an interview on 1/29/25 at 12:15 p.m., with Licensed Nurse 2 (LN 2), she stated, infection control in-service was done on zoom meeting and did not have an in person or annual training about infection prevention (IP). LN 2 further stated she was not aware of any type of surveillance for IP done by the HHA and were updated only by the Staffing Coordinator (SC) about IP over the phone as needed. LN 2 acknowledged, she conducted home visits and had requested several times to provide them with antibacterial wipes to sanitized medical equipment and work area before and after visits, to prevent possible transmission of infection to the patients but the HHA had not provided their request yet. LN 2 further acknowledge, she did not remember getting trained by the HHA on how to properly don and doff Personal Protective Equipment (PPE, used to prevent or minimize exposure to hazards) but relied on what she had learned from her other job. During an interview on 1/29/25 at 12:32 p.m., with LN 4, LN 4 stated, she completed her new employee training online/zoom meetings that included IP, and LN 4 was not aware if they had an IP resource and who was the IP resource for HHA. LN 4 mentioned, the HHA staff update LNs over the phone for IP information as needed, but there was no annual IP training and IP surveillance implemented by the HHA. LN 4 confirmed, she conducted home visits for disabled and diabetic patients and wished antibacterial wipes were provided to disinfect work area and medical equipment to promote infection control. During an interview on 1/29/25 at 1:31 p.m., with Staffing Coordinator (SC), the SC stated, she was not a nurse and unable to answer clinical questions, and the Director of Patient Care Services (DPCS) was not available to answer questions as well. During a review of the HHA’s policy and procedure, titled “Surveillance, Prevention, and Control of Infections,” revised July 2016, indicated, …”1. Establish the mechanisms by which the organization will address surveillance, prevention, identification, control and reporting of infections, utilizing current scientific methods and epidemiologic principles 2. Guide organization personnel in the care and services they provide in relation to infection control practice 3. Educate organization personnel, patients, family/caregivers, and others in the prevention and control of infections 4. Provide for surveillance systems to track the occurrence and transmission of infections… committed to reducing the risk of acquisition and transmission of health care associated infections (HAIs). Recognized prevention and control mechanisms will be implemented for planning, surveillance, identification, prevention/controls, and reporting procedures. To determine the effectiveness of the infection control plan,.. will measure, assess, improve, and redesign (as appropriate) the surveillance, identification, prevention, and control function annually through its performance improvement program…” During a review of the HHA’s policy and procedure, titled “Leadership,” revised October 2008, indicated, “…1. Senior management will meet routinely to discuss any of the following… H. Surveillance, prevention and control of infections, including patient and organization personnel infections, and trends…”

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to provide Infection control education to staff at periodic intervals consistent with accepted standards of practice for 7 sampled patients. This failure may compromise the staff’s competence to identify such as, infection signs and symptoms, routes of infection transmission and to appropriately sanitize medical equipment used for patient care. During an interview on 1/29/25 at 12:15 p.m., with Licensed Nurse 2 (LN 2), she stated, infection control in-service was done on zoom meetings and did not have an in person or annual training about infection prevention (IP). LN 2 further stated she was not aware of any type of surveillance for IP done by the HHA and were updated only by the Staffing Coordinator (SC) about IP over the phone as needed. LN 2 acknowledged, she conducted home visits and had requested several times to provide them with antibacterial wipes to sanitized medical equipment and work area before and after visits, to prevent possible transmission of infection to the patients but the HHA had not provided their request yet. LN 2 further acknowledge, she did not remember getting trained by the HHA on how to properly don and doff Personal Protective Equipment (PPE, used to prevent or minimize exposure to hazards) but relied on what she has learned from her other job. During an interview on 1/29/25 at 12:32 p.m., with Licensed Nurse 4 (LN 4), LN 4 stated, she completed her new employee trainings online were done online/zoom meetings that included IP, and LN 4 was not aware if they have an IP resource and who was the IP resource for HHA. LN 4 mentioned, the HHA staff update LNs over the phone for IP information as needed, but there was no annual IP training and IP surveillance implemented by the HHA. LN 4 confirmed, she conducted home visits for disabled and diabetic patients and wished antibacterial wipes were provided to disinfect work area and medical equipment to promote infection control. During an interview on 1/29/25 at 1:31 p.m., with Staffing Coordinator (SC), the SC stated, she was not a nurse and unable to answer clinical questions, and the Director of Patient Care Services (DPCS) was not available to answer questions as well. During a review of the HHA’s policy and procedure titled, “Tuberculosis Exposure Control Plan,” revised July 2016, indicated, “… 8. All home health personnel will receive training/education upon hire, and annually thereafter. The education will include: C. Principles of infection control to reduce risk of transmission…” During a review of the HHA’s policy and procedure titled, “Leadership,” revised October 2008, indicated, “…1. Senior management will meet routinely to discuss any of the following, as pertinent: … F. Clinical operations (assessment, care, treatment, service, coordination of care, patient and family/caregiver education), including, but not limited to, services being provided, operational issues, new program development, utilization review issues, and patient and family/caregiver concerns…H. Surveillance, prevention and control of infections, including patient and organization personnel infections, and trends…”

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 interview and record review, it was determined the Home Health Agency (HHA) failed to ensure skilled professional services are delivered and supervised only by health care professionals (G702); failed to ensure the plan of care was developed and evaluated in partnership with the patient, representative or caregiver(s) (G708); failed to provide services that are ordered by the physician in the plan of care (G710); failed to communicate with all physicians involved in the plan of care (G718); and failed to ensure nursing services were provided under the supervision of a registered nurse (G726). The extent and cumulative effect of these systemic practices resulted in the agency's inability to ensure that the patients' nursing needs were coordinated and provided as ordered.

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure skilled professional services were delivered and supervised only by health care professionals who met the appropriate qualifications and according to the HHA's (home health agency) policies and procedures for four out of seven sampled patients (Patient 1, 2, 4, and 6). This failure had the potential for the patients care needs, including frequency of visits and services provided, to be unmet causing possible adverse events. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that Patient 2 was planned to have two times a day skilled nursing visits. A review of Patient 2's clinical records indicated LVNs were making the daily visits for Patient 2. A further review of Patient 2's clinical record did not indicate that supervisory visits for the LVNs by a Registered Nurse (RN) were being done. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures). A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed that Patient 4 was planned to have two times a day, five days in a week, skilled nursing visits. A review of Patient 4's clinical records indicated LVNs were making the visits for Patient 4. A further review of Patient 4's clinical record did not indicate that supervisory visits for the LVNs by an RN were being done. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2 and Patient 4's clinical record was reviewed. The SC confirmed that Patient 2 and Patient 4's clinical records did not indicate that supervisory visits for the LVNs doing the skilled nursing visits by an RN were being done. During a review of the agency's policy and procedure (P&P) titled, "Supervisory Visits," undated, indicated, "The registered nurse or therapist must conduct supervisory visits to the patient’s residence at regular intervals... The frequency of supervisory visits will be based on the patient's needs after the treatment plan is established. They must be conducted at least every 62 days, and every two (2) weeks for home health aide services for a patient in conjunction with skilled nursing services and a written plan of treatment.... The registered nurse will be responsible for...Supervision of all services provided for in the plan of treatment. If the patient receives skilled care, the registered nurse will make an on-site visit to the patient's home no less frequently than every two weeks. At least once/month, the clinician should be present. The registered nurse will provide the initial assessment of the patient and the care environment.... When a licensed vocational nurse is delegated supervision of services that are provided in conjunction with skilled nursing services, a registered nurse will make the on-site supervisory visit to the patient’s home at least every three months, to observe the patient and patient care environment. When a licensed vocational nurse is delegated supervision of personal care services, a registered nurse will retain responsibility for supervision of licensed and unlicensed personnel providing such services." "Supervisory visits and overall supervision will be documented in the clinical record...Supervisory visits will be documented on a supervisory visit form. Ongoing supervision will be documented within the plan of treatment, home health aide assignment sheet, and clinical notes." During a review of the agency's P&P titled, "Responsibilities/Supervision of Clinical Services," revised October 2008, indicated, "To ensure a process is in place for the selection of a qualified individual for overseeing all clinical care and services." The Director of Patient Care Services and Nurse Supervisor will monitor the care and service provided by organization personnel...Monitoring includes the review of performance improvement results, incident reports, infection reports, clinical record review results, etc. Any noted trends of individual performance will be used during the evaluation process." During a review of Patient 1's "Home Health Certification and Plan of Care," dated 12/13/24 to 2/10/25 indicated an order for Skilled Nurse (SN) visits 4 times a day. Review of Patient 1's SN visit notes revealed Licensed Vocational Nurses (LVN) were making the daily visits. Review of Patient 1's clinical record revealed no documentation supervisory visits were being made. During the review of Patient 6's "Home Health Certification and Plan of Care," dated 12/16/24 to 2/13/205 indicated an order for SN visits 4 times a day. Review of Patient 6's SN visit notes were revealed LVNs were making the daily visits. Review of Patient 6's clinical record revealed no documentation supervisory visits were being made. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. During an interview on 1/29/25 at 1:27 p.m. with the SC, she was asked if Registered Nurse (RN) supervisory visits were done. The SC stated that was a clinical question and would need to ask DPCS 1. SC placed a telephone to DCPS 1 but there was no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." During a review of the agency's policy and procedure (P&P) titled, "Supervisory Visits," undated, indicated, "The registered nurse or therapist must conduct supervisory visits to the patient’s residence at regular intervals... The frequency of supervisory visits will be based on the patient's needs after the treatment plan is established. They must be conducted at least every 62 days, and every two (2) weeks for home health aide services for a patient in conjunction with skilled nursing services and a written plan of treatment.... The registered nurse will be responsible for...Supervision of all services provided for in the plan of treatment. If the patient receives skilled care, the registered nurse will make an on-site visit to the patient's home no less frequently than every two weeks. At least once/month, the clinician should be present. The registered nurse will provide the initial assessment of the patient and the care environment.... When a licensed vocational nurse is delegated supervision of services that are provided in conjunction with skilled nursing services, a registered nurse will make the on-site supervisory visit to the patient’s home at least every three months, to observe the patient and patient care environment. When a licensed vocational nurse is delegated supervision of personal care services, a registered nurse will retain responsibility for supervision of licensed and unlicensed personnel providing such services." "Supervisory visits and overall supervision will be documented in the clinical record...Supervisory visits will be documented on a supervisory visit form. Ongoing supervision will be documented within the plan of treatment, home health aide assignment sheet, and clinical notes." During a review of the agency's P&P titled, "Responsibilities/Supervision of Clinical Services," revised October 2008, indicated, "To ensure a process is in place for the selection of a qualified individual for overseeing all clinical care and services." The Director of Patient Care Services and Nurse Supervisor will monitor the care and service provided by organization personnel...Monitoring includes the review of performance improvement results, incident reports, infection reports, clinical record review results, etc. Any noted trends of individual performance will be used during the evaluation process."

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 interview and record review, the agency failed to ensure the plan of care (POC) was developed and evaluated in partnership with the patient, representative or caregiver(s) for five out of seven sampled patients (Patient 1, 2, 4. 5, and 6). This failure had the potential for patients, their representative or caregiver(s) to be unaware of the patient's individualized plan of care. During a review of Patient 1's "Home Health Certification and Plan of Care (POC)," for the certification periods 7/16/24 to 10/13/24, 10/14/24 to 12/12/24, and 12/13/24 to 2/10/25 revealed the POCs had not been signed by a physician or were developed and evaluated in partnership with the patient, representative or caregiver(s). During a review of Patient 5's "Home Health Certification and Plan of Care," for the certification periods 6/23/24 to 9/20/24 and11/20/24 to 1/18/25 revealed the POCs had not been signed by a physician or was developed and evaluated in partnership with the patient, representative or caregiver(s). During a review of Patient 6's "Home Health Certification and Plan of Care," for the certification periods 10/17/24 to 12/15/24 and 12/16/24 to 2/13/25 revealed the POCs had not been signed by a physician or was developed and evaluated in partnership with the patient, representative or caregiver(s). During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated the Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." Review of the agency's P&P tilted, "Care Planning Process," revised October 2008 indicated, "A written plan of treatment will be established for each patient whose care requires medical orders... The patient and family/caregiver will participate in decisions regarding the plan of treatment whenever possible. The care planning process will be documented on the plan of treatment, individualized discipline-specific care plans (if applicable), clinical notes, medication profiles, care conference/summary forms, and discharge/clinical summaries....At the time of the initial assessment, the clinician, along with other involved disciplines, will develop the patient plan of treatment based upon the patient’s identified needs and will review it with the patient and family/caregiver." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that the POC was not signed by a physician. There was also no documented evidence that the plan of care was developed and evaluated in partnership with the patient, representative or caregiver(s). During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's POC dated 12/14/24 was not signed by a physician. The SC further confirmed that there was no documented evidence that the plan of care was developed and evaluated in partnership with the patient, representative or caregiver(s). A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures) A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/12/24, revealed that the POC was not signed by a physician. There was also no documented evidence that the plan of care was developed and evaluated in partnership with the patient, representative or caregiver(s). A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed that the POC was not signed by a physician. There was also no documented evidence that the plan of care was developed and evaluated in partnership with the patient, representative or caregiver(s). During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical record was reviewed. The SC confirmed that Patient 4's POCs dated 10/12/24 and 12/12/24 were both not signed by a physician. The SC further confirmed that there was no documented evidence that the plan of care was developed and evaluated in partnership with the patient, representative or caregiver(s). Review of the agency's P&P tilted, "Care Planning Process," revised October 2008 indicated, "A written plan of treatment will be established for each patient whose care requires medical orders... The patient and family/caregiver will participate in decisions regarding the plan of treatment whenever possible. The care planning process will be documented on the plan of treatment, individualized discipline-specific care plans (if applicable), clinical notes, medication profiles, care conference/summary forms, and discharge/clinical summaries....At the time of the initial assessment, the clinician, along with other involved disciplines, will develop the patient plan of treatment based upon the patient’s identified needs and will review it with the patient and family/caregiver." During a review of Patient 1's "Home Health Certification and Plan of Care (POC)," for the certification periods 7/16/24 to 10/13/24, 10/14/24 to 12/12/24, and 12/13/24 to 2/10/25 revealed the POCs had not been signed by a physician or were developed and evaluated in partnership with the patient, representative or caregiver(s). A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that the POC was not signed by a physician. There was also no documented evidence that the plan of care was developed and evaluated in partnership with the patient, representative or caregiver(s). During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's POC dated 12/14/24 was not signed by a physician. The SC further confirmed that there was no documented evidence that the plan of care was developed and evaluated in partnership with the patient, representative or caregiver(s). A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures) A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/12/24, revealed that the POC was not signed by a physician. There was also no documented evidence that the plan of care was developed and evaluated in partnership with the patient, representative or caregiver(s). A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed that the POC was not signed by a physician. There was also no documented evidence that the plan of care was developed and evaluated in partnership with the patient, representative or caregiver(s). During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical record was reviewed. The SC confirmed that Patient 4's POCs dated 10/12/24 and 12/12/24 were both not signed by a physician. The SC further confirmed that there was no documented evidence that the plan of care was developed and evaluated in partnership with the patient, representative or caregiver(s). During a review of Patient 5's "Home Health Certification and Plan of Care," for the certification periods 6/23/24 to 9/20/24 and11/20/24 to 1/18/25 revealed the POCs had not been signed by a physician or was developed and evaluated in partnership with the patient, representative or caregiver(s). During a review of Patient 6's "Home Health Certification and Plan of Care," for the certification periods 10/17/24 to 12/15/24 and 12/16/24 to 2/13/25 revealed the POCs had not been signed by a physician or was developed and evaluated in partnership with the patient, representative or caregiver(s). During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated the Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." Review of the agency's P&P tilted, "Care Planning Process," revised October 2008 indicated, "A written plan of treatment will be established for each patient whose care requires medical orders... The patient and family/caregiver will participate in decisions regarding the plan of treatment whenever possible. The care planning process will be documented on the plan of treatment, individualized discipline-specific care plans (if applicable), clinical notes, medication profiles, care conference/summary forms, and discharge/clinical summaries....At the time of the initial assessment, the clinician, along with other involved disciplines, will develop the patient plan of treatment based upon the patient’s identified needs and will review it with the patient and family/caregiver."

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 interview and record review, the agency failed to provide services that are ordered by the physician or allowed practitioner as indicated in the plan of care and follow the planned frequency of visits for five out of seven sampled patients (Patient 1, 2, 4, 5, and 6). This failure resulted in the agency's inability to ensure the patients' nursing needs were provided as ordered. During a review of Patient 1's "Home Health Certification and Plan of Care (POC)," for the certification periods 7/16/24 to 10/13/24, 10/14/24 to 12/12/24, and 12/13/24 to 2/10/25 revealed the POCs had not been signed by a physician. During a review of Patient 5's "Home Health Certification and Plan of Care," for the certification periods 6/23/24 to 9/20/24 and11/20/24 to 1/18/25 revealed the POCs had not been signed by a physician. During a review of Patient 6's "Home Health Certification and Plan of Care," for the certification periods 10/17/24 to 12/15/24 and 12/16/24 to 2/13/25 revealed the POCs had not been signed by a physician. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated the Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." Review of the agency's policy and procedure titled, " Care Planning Process," revised October 2008, indicated, "A written plan of treatment will be established for each patient whose care requires medical orders. A plan of treatment will be approved and signed within 30 working days by the attending physician, dentist, or podiatrist...The plan of treatment will be reviewed and updated by the attending physician, dentist, or podiatrist in consultation with the agency health professional personnel as frequently as the patient’s condition warrants and at least every 62 days." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/14/24, revealed that the POC was not signed by a physician. There was also no documented evidence that services being provided to Patient 2 were ordered by a physician or allowed practitioner. A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that the POC was not signed by a physician. There was also no documented evidence that services being provided to Patient 2 were ordered by a physician or allowed practitioner. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's POCs dated 10/14/24 and 12/14/24 were both not signed by a physician. The SC further confirmed that there was no documented evidence that the plan of care was developed and evaluated in partnership with the patient, representative or caregiver(s). A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures) A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/12/24, revealed that the POC was not signed by a physician. There was also no documented evidence that services being provided to Patient 4 were ordered by a physician or allowed practitioner. A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed that the POC was not signed by a physician. A further review of the POC also revealed that Patient 4 was planned to have two times a day, five days in a week, skilled nursing visits. There was also no documented evidence that services being provided to Patient 4 were ordered by a physician or allowed practitioner. A review of Patient 4's clinical records revealed that Patient 4 did not had any visit on the week of 12/22/24 to 12/28/24, only had two days visit on the week of 12/29/24 to 1/4/25, only had four days visit on the week of 1/5/25 to 1/11/25, and only had four days visit on the week of 1/19/25 to 1/25/25. There were no evidence that the change in the frequency of planned visits were communicated to Patient 4's physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical record was reviewed. The SC confirmed that Patient 4's POCs dated 10/12/24 and 12/12/24 were not signed by a physician. The SC also confirmed that there was no documented evidence that services being provided to Patient 4 were ordered by a physician or allowed practitioner. The further confirmed that the planned frequency of skille nursing visit for Patient 4 was not followed and that there were no evidence that the change in the frequency of planned visits were communicated to Patient 4's physician. Review of the agency's policy and procedure titled, " Care Planning Process," revised October 2008, indicated, "A written plan of treatment will be established for each patient whose care requires medical orders. A plan of treatment will be approved and signed within 30 working days by the attending physician, dentist, or podiatrist...The plan of treatment will be reviewed and updated by the attending physician, dentist, or podiatrist in consultation with the agency health professional personnel as frequently as the patient’s condition warrants and at least every 62 days. During a review of Patient 1's "Home Health Certification and Plan of Care (POC)," for the certification periods 7/16/24 to 10/13/24, 10/14/24 to 12/12/24, and 12/13/24 to 2/10/25 revealed the POCs had not been signed by a physician. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/14/24, revealed that the POC was not signed by a physician. There was also no documented evidence that services being provided to Patient 2 were ordered by a physician or allowed practitioner. A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that the POC was not signed by a physician. There was also no documented evidence that services being provided to Patient 2 were ordered by a physician or allowed practitioner. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2's clinical record was reviewed. The SC confirmed that Patient 2's POCs dated 10/14/24 and 12/14/24 were both not signed by a physician. The SC further confirmed that there was no documented evidence that the plan of care was developed and evaluated in partnership with the patient, representative or caregiver(s). A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures) A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/12/24, revealed that the POC was not signed by a physician. There was also no documented evidence that services being provided to Patient 4 were ordered by a physician or allowed practitioner. A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed that the POC was not signed by a physician. A further review of the POC also revealed that Patient 4 was planned to have two times a day, five days in a week, skilled nursing visits. There was also no documented evidence that services being provided to Patient 4 were ordered by a physician or allowed practitioner. A review of Patient 4's clinical records revealed that Patient 4 did not have any visit on the week of 12/22/24 to 12/28/24, only had two days visit on the week of 12/29/24 to 1/4/25, only had four days visit on the week of 1/5/25 to 1/11/25, and only had four days visit on the week of 1/19/25 to 1/25/25. There was no evidence that the change in the frequency of planned visits were communicated to Patient 4's physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 4's clinical record was reviewed. The SC confirmed that Patient 4's POCs dated 10/12/24 and 12/12/24 were not signed by a physician. The SC also confirmed that there was no documented evidence that services being provided to Patient 4 were ordered by a physician or allowed practitioner. The further confirmed that the planned frequency of skilled nursing visit for Patient 4 was not followed and that there was no evidence that the change in the frequency of planned visits were communicated to Patient 4's physician. During a review of Patient 5's "Home Health Certification and Plan of Care," for the certification periods 6/23/24 to 9/20/24 and11/20/24 to 1/18/25 revealed the POCs had not been signed by a physician. During a review of Patient 6's "Home Health Certification and Plan of Care," for the certification periods 10/17/24 to 12/15/24 and 12/16/24 to 2/13/25 revealed the POCs had not been signed by a physician. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated the Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." Review of the agency's policy and procedure titled, " Care Planning Process," revised October 2008, indicated, "A written plan of treatment will be established for each patient whose care requires medical orders. A plan of treatment will be approved and signed within 30 working days by the attending physician, dentist, or podiatrist...The plan of treatment will be reviewed and updated by the attending physician, dentist, or podiatrist in consultation with the agency health professional personnel as frequently as the patient’s condition warrants and at least every 62 days."

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to communicate with all physicians involved in the plan of care and other health care practitioners related to the current plan of care for seven out of seven sampled patients (Patient 1, 2, 3, 4, 5, 6, and 7). This failure resulted in the agency's inability to ensure that the patients' nursing needs were coordinated and provided as ordered. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus. A review of Patient 7's clinical records indicated Patient 7 had a start of care date with the HHA on 8/20/24 and was discharged on 9/27/24 with no diagnosis listed. During a review of Patient 3's comprehensive assessment titled, "Home Health Certification and Plan of Care", dated 1/2/25 to 3/2/25, revealed the comprehensive assessment was not signed by a physician. During a review of Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", indicated the start of care was 8/20/24 and the initial assessment by a registered nurse was completed on 8/28/24. The assessment was not signed by a physician. During a concurrent interview and record review on 1/28/25 at 9:35 a.m. with the SC, Patient 3's and Patient 7’s clinical records were reviewed. The SC confirmed the comprehensive assessment for both Patient 3 and Patient 7 were not signed by a physician. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/14/24, revealed that the POC was not communicated and signed by a physician. A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that the POC was not communicated and signed by a physician. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures) A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/12/24, revealed that the POC was not communicated and signed by a physician. A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed that the POC was not communicated and signed by a physician. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2 and Patient 4's clinical records were reviewed. The SC confirmed that Patient 2's POCs dated 10/14/24 and 12/14/24, and Patient 4's POCs dated 10/12/24 and 12/12/24 were not communicated and signed by a physician. During a review of Patient 1's "Home Health Certification and Plan of Care (POC)," for the certification periods 7/16/24 to 10/13/24, 10/14/24 to 12/12/24, and 12/13/24 to 2/10/25 revealed the POCs had not been signed by a physician. During a review of Patient 5's "Home Health Certification and Plan of Care," for the certification periods 6/23/24 to 9/20/24 and11/20/24 to 1/18/25 revealed the POCs had not been signed by a physician. During a review of Patient 6's "Home Health Certification and Plan of Care," for the certification periods 10/17/24 to 12/15/24 and 12/16/24 to 2/13/25 revealed the POCs had not been signed by a physician. There was no documentation the agency communicated with physicians involved in the plan of care and other health care practitioners related to the plan of care. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated the Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." Review of the agency's policy and procedure titled, "Physican Participation in the Plan of Treatment," revised October 2008, indicated, "A physician will direct the care of every home health patient that requires medical orders admitted for service. The attending physician will certify that medical and skilled services provided by the organization are medically required for the patient. The attending physician will participate in the care planning process by reviewing and revising therapeutic and diagnostic orders. The care will be provided in compliance with his/her therapeutic and diagnostic orders and accepted standards and practice."

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 interview and record review, the agency failed to ensure nursing services were provided under the supervision of a registered nurse for five out of seven sampled patients (Patient 1, 2, 4, and 6). This failure had the potential for the patients care needs, including frequency of visits and services provided, to be unmet causing possible adverse events. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that Patient 2 was planned to have two times a day skilled nursing visits. A review of Patient 2's clinical records indicated LVNs were making the daily visits for Patient 2. A further review of Patient 2's clinical record did not indicate that supervisory visits for the LVNs by a Registered Nurse (RN) were being done. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures). A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed that Patient 4 was planned to have two times a day, five days in a week, skilled nursing visits. A review of Patient 4's clinical records indicated LVNs were making the visits for Patient 4. A further review of Patient 4's clinical record did not indicate that supervisory visits for the LVNs by an RN were being done. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2 and Patient 4's clinical record was reviewed. The SC confirmed that Patient 2 and Patient 4's clinical records did not indicate that supervisory visits for the LVNs doing the skilled nursing visits by an RN were being done. During a review of the agency's policy and procedure (P&P) titled, "Supervisory Visits," undated, indicated, "The registered nurse or therapist must conduct supervisory visits to the patient’s residence at regular intervals... The frequency of supervisory visits will be based on the patient's needs after the treatment plan is established. They must be conducted at least every 62 days, and every two (2) weeks for home health aide services for a patient in conjunction with skilled nursing services and a written plan of treatment....The registered nurse will be responsible for...Supervision of all services provided for in the plan of treatment. If the patient receives skilled care, the registered nurse will make an on-site visit to the patient's home no less frequently than every two weeks. At least once/month, the clinician should be present. The registered nurse will provide the initial assessment of the patient and the care environment....When a licensed vocational nurse is delegated supervision of services that are provided in conjunction with skilled nursing services, a registered nurse will make the on-site supervisory visit to the patient’s home at least every three months, to observe the patient and patient care environment. When a licensed vocational nurse is delegated supervision of personal care services, a registered nurse will retain responsibility for supervision of licensed and unlicensed personnel providing such services." "Supervisory visits and overall supervision will be documented in the clinical record...Supervisory visits will be documented on a supervisory visit form. Ongoing supervision will be documented within the plan of treatment, home health aide assignment sheet, and clinical notes." During a review of the agency's P&P titled, "Responsibilities/Supervision of Clinical Services," revised October 2008, indicated, "To ensure a process is in place for the selection of a qualified individual for overseeing all clinical care and services." The Director of Patient Care Services and Nurse Supervisor will monitor the care and service provided by organization personnel...Monitoring includes the review of performance improvement results, incident reports, infection reports, clinical record review results, etc. Any noted trends of individual performance will be used during the evaluation During a review of Patient 1's "Home Health Certification and Plan of Care," dated 12/13/24 to 2/10/25 indicated an order for Skilled Nurse (SN) visits 4 times a day. Review of Patient 1's SN visit notes revealed Licensed Vocational Nurses (LVN) were making the daily visits. Review of Patient 1's clinical record revealed no documentation supervisory visits were being made. During the review of Patient 6's "Home Health Certification and Plan of Care," dated 12/16/24 to 2/13/205 indicated an order for SN visits 4 times a day. Review of Patient 6's SN visit notes were revealed LVNs were making the daily visits. Review of Patient 6's clinical record revealed no documentation supervisory visits were being made. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. During an interview on 1/29/25 at 1:27 p.m. with the SC, she was asked if Registered Nurse (RN) supervisory visits were done. The SC stated that was a clinical question and would need to ask DPCS 1. SC placed a telephone to DCPS 1 but there was no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." During a review of the agency's policy and procedure (P&P) titled, "Supervisory Visits," undated, indicated, "The registered nurse or therapist must conduct supervisory visits to the patient’s residence at regular intervals... The frequency of supervisory visits will be based on the patient's needs after the treatment plan is established. They must be conducted at least every 62 days, and every two (2) weeks for home health aide services for a patient in conjunction with skilled nursing services and a written plan of treatment....The registered nurse will be responsible for...Supervision of all services provided for in the plan of treatment. If the patient receives skilled care, the registered nurse will make an on-site visit to the patient's home no less frequently than every two weeks. At least once/month, the clinician should be present. The registered nurse will provide the initial assessment of the patient and the care environment....When a licensed vocational nurse is delegated supervision of services that are provided in conjunction with skilled nursing services, a registered nurse will make the on-site supervisory visit to the patient’s home at least every three months, to observe the patient and patient care environment. When a licensed vocational nurse is delegated supervision of personal care services, a registered nurse will retain responsibility for supervision of licensed and unlicensed personnel providing such services." "Supervisory visits and overall supervision will be documented in the clinical record...Supervisory visits will be documented on a supervisory visit form. Ongoing supervision will be documented within the plan of treatment, home health aide assignment sheet, and clinical notes." During a review of the agency's P&P titled, "Responsibilities/Supervision of Clinical Services," revised October 2008, indicated, "To ensure a process is in place for the selection of a qualified individual for overseeing all clinical care and services." The Director of Patient Care Services and Nurse Supervisor will monitor the care and service provided by organization personnel...Monitoring includes the review of performance improvement results, incident reports, infection reports, clinical record review results, etc. Any noted trends of individual performance will be used during the evaluation process."

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 interview and record review, the agency and its staff failed to operate and furnish services in compliance with all applicable federal regulations related to the health and safety of patients. The cumulative effect of these systemic practices resulted in the agency's not operating and furnishing services in compliance with all applicable federal regulations.

Laboratory services/CLIA waivers CFR(s): 484.100(c)(1) Laboratory services. If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient's equipment when assisting with self-administered tests. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to obtain a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver when employees conducted blood glucose meter testing (test to measure amount of sugar in the blood) for two out of seven sampled patients (Patient 2 and Patient 4). This failure had the potential for unsafe blood glucose meter testing of patients. 1a. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the HHA on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's visit notes, from 1/20/25 to 1/26/25, indicated blood glucose meter testing was performed by the visiting skilled nurse. During a concurrent observation and interview on 1/28/25, during a home visit of Patient 2 at 11:20 a.m., with Licensed Nurse (LN) 2, LN 2 was observed performing blood glucose meter test on Patient 2. LN 2 stated she has been checking Patient 2's blood glucose ever since she was assigned to Patient 2. 1b. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures) A review of Patient 4's visit notes, from 1/23/25 to 1/24/25, indicated blood glucose meter testing was performed by the visiting skilled nurse. The HHA's CLIA Certificate of Waiver was requested from the Staffing Coordinator (SC) on 1/28/25 at 10 a.m. A review of the email sent by the SC on 1/28/25 at 12:29 p.m. indicated, "Regarding CLIA - Per [name of HHA president] N/A [not applicable] our company does not handle any transport any blood or specimen" During an interview on 1/29/25 at 10:50 a.m. with the SC, the SC confirmed that the HHA does not have a CLIA Certificate of Waiver. A review of the Centers of Medicare & Medicaid Services' online publication titled, "Over-The-Counter (OTC) Home Testing and CLIA Applicability", last updated 3/4/22, indicated, "If the test is either performed by someone other than the individual being tested (e.g., other staff, employee health personnel), or the results are interpreted and reported by someone other than the individual, then a CLIA certificate would be required..." (https://www.cms.gov/files/document/over-counter-otc-home-testing-and-clia-applicability.pdf)

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to have a governing body (or designated persons so functioning) who assumed full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program (G942); failed to provide documentation that the Administrator was appointed by and reported to the governing body (G946); failed to ensure the Administrator was responsible for all day-to-day operations of the agency (G948); failed to have documentation 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 (G954); failed to provide skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) (G982); and failed to prepare an overall plan and a budget that included an annual operating budget and capital expenditure plan that was reviewed and updated at least annually under the direction of the governing body (G988). The cumulative effect of these systemic practices resulted in the agency's inability to meet the patients' needs and provide oversight to the clinical staff. This COP was also taken out in the agency's previous Recertification survey on 3/11/22.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to have a governing body (or designated persons so functioning) who assumed full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program for a census of 19. This failure negatively impacted the day-to-day operations of the agency and resulted in the agency' s inability to remain in compliance with Federal Regulations. Based on interview and record review, the governing body (or designated persons so functioning) failed to provide full legal authority and responsibility for the agency's overall management and operation and the provision of all home health services by having 10 of 15 Condition of Participations (COPs) out, by providing only skilled nursing services and not at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services), by changing their name without notifying the Department, by not providing documentation of agency's fiscal operations, the agency's budget and operational plans and its quality assessment and performance improvement program, by not having an appointed qualified Administrator, by not having a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, to assume the same responsibilities and obligations as the administrator when they are not available, and by not cooperating with the Department conduction of the agency's recertification survey. Review of the agency's policy and procedure (P&P) titled, "Governing Body," revised 2008, indicated, "The Governing Body will assume full legal authority and responsibility for the operation of 24/7 MedStaff. The Governing Body of 24/7 MedStaff will serve as the governing authority for the home health program, which will function according to 24/7 MedStaff’s bylaws... The Governing Body will review 24/7 MedStaff’s bylaws at least annually. The Governing Body will appoint a Professional Advisory Committee to review and develop official policies and procedures, prepare an annual evaluation of 24/7 MedStaff, and assist in identifying goals and measuring accomplishments of the organization's operations. The Governing Body will assume responsibility for the management and fiscal affairs of the agency and will routinely review all fiscal affairs and the financial position of 24/7 MedStaff. The Governing Body will routinely evaluate to what extent the organization has met the needs of the community for home health, has provided adequate and appropriate care to patients, and is working toward a goal of financial self-sufficiency. The Governing Body will appoint a qualified Executive Director/Administrator who will be responsible for day-to-day management of the organization, and will establish procedures for systematic executive communication. Performance of the Executive Director/ Administrator will be monitored regularly through a procedure established by the Governing Body. The process and documentation will reflect that: A. Relevant findings of performance improvement activities are consistently provided to the Governing Body B. Other information relevant to the quality of patient care (i.e., unusual occurrences in care delivered is also consistently provided through a defined process)." During a review of the agency's P&P titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence."

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) Standard: Administrator. The administrator must: (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to provide documentation that the Administrator was appointed by and reported to the governing body for a census of 19. This failure negatively impacted the day-to-day operations of the agency and resulted in the agency' s inability to remain in compliance with Federal Regulations. The agency failed to provide documentation that the administrator was appointed by and reported to the governing body. Review of the agency's policy and procedure (P & P) titled, "Governing Body," revised 2008, indicated, "The Governing Body will appoint a qualified Executive Director/Administrator who will be responsible for day-to-day management of the organization, and will establish procedures for systematic executive communication. Performance of the Executive Director/ Administrator will be monitored regularly through a procedure established by the Governing Body." Review of the agency's P & P titled, "Appointment of Administrator," revised October 2008, indicated, "The Governing Body will appoint the Executive Director/Administrator through a procedure established by the Governing Body. The Executive Director/Administrator will be responsible for the day-to-day operations of the organization. Have the necessary authority to implement his/her responsibilities for the operations, as conferred by the Governing Body."

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the Administrator was responsible for all day-to-day operations of the agency for a census of 19. This failure negatively impacted the day-to-day operations of the agency and resulted in the agency's inability to remain in compliance with Federal Regulations. Review of the Administrator's resume indicated she was the Staffing Coordinator for the agency from August 2015-July 2017, then she was the Staffing Manager and Recruiter for the agency from July 2017 to September 2018 and then Long Term Care Lead and School Services Manager for the agency for the agency from October 2018 until she was appointed the agency's Administ roar. The Department did not receive documentation of when the Administrator was appointed by the Governing Body. There was no documentation the Administrator met the qualifications for the HHA's Administrator. The Administrator was not available to be interviewed during the Recertification Survey. Review of the agency's policy and procedure (P&P) titled, "Appointment of Administrator" revised October 2008 indicated, "The Executive Director/Administrator will: 1. Be responsible for the day-to-day operations of the organization...3. Have the education and/or experience appropriate to fulfill his/her responsibilities and have knowledge of service systems in the community served by the organization, as outlined in the job description. 4. Take reasonable steps to ensure that: A. The organization complies with applicable law and regulation. Review of the agency's P&P titled, "Governing Body," revised 2008, indicated, "The Governing Body will appoint a qualified Executive Director/Administrator who will be responsible for day-to-day management of the organization..."

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 agency failed to have documentation 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 for a census of 19. This failure negatively impacted the day-to-day operations of the agency and resulted in the agency's inability to remain in compliance with Federal Regulations. The agency failed to provide documentation 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. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 10:35 a.m. with SC, the SC stated she was appointed as the administrator designee a few months ago when the agency changed their name. Her previous work experience included HR (Human Resources) and Recruiter and a HR receptionist at a home health agency. The SC stated she has not taken any special training or courses or have any education for the position of administrator designee. During a review of the agency's policy and procedure (P & P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." The P & P indicated the Director of Patient Care Services was [DPCS 2] and the Qualified Nurse was [LN 1] During an interview on 1/27/25 at 9:01 a.m. with the SC, she stated the agency's Director of Patient Care Services (DPCS) was DPCS 1. During a review of an agency documentation labeled, "HH Nurse List," received by the Department on 1/27/25 revealed DPCS 2 and LN 1's names were not on the provided list of current staff working for the agency.

Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to provide skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) which are made available on a visiting basis, in a place of residence used as a patient's home. This failure resulted in the agency not meeting the definition of a Home Health Agency. During an interview on 1/29/25 at 9:53 a.m. with the Staffing Coordinator (SC) she stated they don't have or contract with any outside company for therapeutic rehabilitation services, medical social services or home health services. The SC stated the only service the agency provides is skilled nursing services. During a review of the agency's policy and procedure (P&P) titled, "Scope of Services," revised October 2008, indicated, "Services will be provided as listed below:" The P&P indicated the following services would be offered "Directly:" "Home Health Aide, Registered Nurse, Licensed Vocational Nurse, Physical Therapist, Occupational Therapist."

Institutional planning CFR(s): 484.105(h) Standard: Institutional planning. The HHA, under the direction of the governing body, prepares an overall plan and a budget that includes an annual operating budget and capital expenditure plan. (1) Annual operating budget. There is an annual operating budget that includes all anticipated income and expenses related to items that would, under generally accepted accounting principles, be considered income and expense items. However, it is not required that there be prepared, in connection with any budget, an item by item identification of the components of each type of anticipated income or expense. (2) Capital expenditure plan. (i) There is a capital expenditure plan for at least a 3-year period, including the operating budget year. The plan includes and identifies in detail the anticipated sources of financing for, and the objectives of, each anticipated expenditure of more than $600,000 for items that would under generally accepted accounting principles, be considered capital items. In determining if a single capital expenditure exceeds $600,000, the cost of studies, surveys, designs, plans, working drawings, specifications, and other activities essential to the acquisition, improvement, modernization, expansion, or replacement of land, plant, building, and equipment are included. Expenditures directly or indirectly related to capital expenditures, such as grading, paving, broker commissions, taxes assessed during the construction period, and costs involved in demolishing or razing structures on land are also included. Transactions that are separated in time, but are components of an overall plan or patient care objective, are viewed in their entirety without regard to their timing. Other costs related to capital expenditures include title fees, permit and license fees, broker commissions, architect, legal, accounting, and appraisal fees; interest, finance, or carrying charges on bonds, notes and other costs incurred for borrowing funds. (ii) If the anticipated source of financing is, in any part, the anticipated payment from title V (Maternal and Child Health Services Block Grant) or title XVIII (Medicare) or title XIX (Medicaid) of the Social Security Act, the plan specifies the following: (A) Whether the proposed capital expenditure is required to conform, or is likely to be required to conform, to current standards, criteria, or plans developed in accordance with the Public Health Service Act or the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963. (B) Whether a capital expenditure proposal has been submitted to the designated planning agency for approval in accordance with section 1122 of the Act (42 U.S.C. 1320a-1) and implementing regulations. (C) Whether the designated planning agency has approved or disapproved the proposed capital expenditure if it was presented to that agency. (3) Preparation of plan and budget. The overall plan and budget is prepared under the direction of the governing body of the HHA by a committee consisting of representatives of the governing body, the administrative staff, and the medical staff (if any) of the HHA. (4) Annual review of plan and budget. The overall plan and budget is reviewed and updated at least annually by the committee referred to in paragraph (i)(3) of this section under the direction of the governing body of the HHA. This STANDARD is not met as evidenced by: Based on interview and record review, the agency's governing body failed to prepare an overall plan and a budget that included an annual operating budget and capital expenditure plan and failed to ensure the overall plan and budget was reviewed and updated at least annually under the direction of the governing body of the HHA (Home Health Agency). This failure negatively impacted the day-to-day operations of the agency and resulted in the agency's inability to remain in compliance with Federal Regulations. The agency failed to provide documentation the governing body prepared an overall plan and a budget that included an annual operating budget. The annual operating budget should include all anticipated income and expenses related to items that would, under generally accepted accounting principles, be considered income and expense items. The agency failed to provide documentation the governing body prepared a capital expenditure plan for at least a 3-year period. A review of the agency's policy and procedure (P&P) titled, "Annual Operating Budget," revised July 2016, indicated, "To provide a written financial plan to ensure sufficient allocation of resources and finances for home health operations." "On an annual basis, senior management will prepare a budget and operating plan to ensure that adequate monies are available to carry out the programs and services designed to meet the needs of the hospice population being served. These documents will be reviewed and approved by the Governing Body." A review of the agency's P&P titled, "Financial Reports," revised 2016, indicated, "To provide senior management with necessary financial information for effective fiscal decision-making...."24/7 MedStaff will maintain and utilize a management information system to generate key financial reports on a monthly basis. Monthly financial reports will include key financial ratios and will directly compare revenue and expense line items...Summary reports will be submitted to the Governing Body at least quarterly. Year-to-date financial performance information will be annualized and utilized to prepare the organization’s annual budget and capital expenditure for the upcoming year. End-of-year financial data will be closely analyzed and compared to historical performance to identify trends, which may influence senior management’s decisions regarding program development, revisions in the existing programs, cessation of existing programs, or redesign of the organization’s marketing plan."

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 agency failed to ensure that clinical records included all interventions, including medication administration, treatments, and services, and responses to those interventions (G1014); failed to ensure there were goals in the patient's plans of care and the patient's progress toward achieving them (G1016); failed to ensure the clinical record contained the contact information for the patient's representative and/or patient's primary caregiver (G1018); and failed to have a completed discharge summary that was sent to the primary care practitioner after discharge within 5 business days of the patient's discharge (G1022). The extent and cumulative effect of these systemic practices resulted in the agency not maintaining clinical records that were accurate and adhered to current clinical record documentation standards of practice.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the clinical record included all interventions, including medication administration, treatments, and services, and responses to those interventions for one of seven sampled patients (Patient 5). This failure had the potential for delay in care and medication errors. During a review of Patient 5's "Home Health Certification and Plan of Care (POC)," for the certification period 11/20/24 to 1/18/25 indicated Skilled Nursing (SN) services need to administer Bisacodyl (laxative) suppository twice a week. During a review of Patient 5's SN visit notes dated 12/23/24, 12/27/24, 12/30/24, 1/3/25, 1/6/25, 1/10/25, 1/13/25, and 1/20/25 revealed no documentation the SN administered Bisacodyl as ordered. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated the Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." Review of the agency's P&P titled, "Contents of the Clinical Record," review July 2016, indicated, "A clinical record will be maintained for each patient receiving care. The clinical record will contain sufficient information to identify the patient, describe the patient’s problems and needs, justify care, accurately document care provided and results in detail...Every dose of medication administered by organization personnel and any adverse drug reaction." Review of the agency's P&P titled, "Entries into the Clinical Record," reviewed July 2016 indicated, "Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided...The clinical note will include: A. Care that was provided B. Treatment and/or invasive procedures performed C. Patient response to treatment and/or procedures..."

Goals in the patient's plans of care CFR(s): 484.110(a)(3) Goals in the patient's plans of care and the patient's progress toward achieving them; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure there were goals in the patient's plans of care and the patient's progress toward achieving them for four out of seven sampled patients (Patient 3, 2, 4, and 6). This failure had the potential to lead to a lack of direction in care and not meeting the patient's needs. A review of Patient 3's clinical records indicated Patient 3 had a start of care date with the HHA on 1/16/18 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 3's comprehensive assessment titled, "Home Health Certification and Plan of Care", dated 1/2/25 to 3/2/25, did not include any patient goals or discharge plan. During a concurrent interview and record review on 1/28/25 at 9:35 a.m. with the SC, Patient 3's clinical record was reviewed. The SC confirmed that Patient 3's comprehensive assessment, dated 1/2/25 to 3/2/25, did not include any patient treatment goals or discharge plan. The SC stated the information should not have been left blank. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed no written goals in the plan of care and the patient's progress toward achieving them. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures) A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 10/12/24, revealed no written goals in the plan of care and the patient's progress toward achieving them. A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed no written goals in the plan of care and the patient's progress toward achieving them. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), Patient 2 and Patient 4's clinical records were reviewed. The SC confirmed that Patient 2's POC dated 12/14/24, and Patient 4's POCs dated 10/12/24 and 12/12/24 had no written goals in the plan of care and the patient's progress toward achieving them. During a review of Patient 6's "Home Health Certification and Plan of Care," for certification period 12/16/24 to 2/13/25 revealed no goals in the plan of care and the patient's progress toward achieving them. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." Review of the agency's policy and procedure titled, "Care Planning Process," revised October 2008 indicated, "The clinical plan of treatment includes, but is not limited to,...goals and interventions appropriate to each discipline..." "Each patient will be monitored for his/her response to care or services provided against established patient goals and patient outcomes to determine if goals have been achieved."

Contact information for the patient CFR(s): 484.110(a)(4) Contact information for the patient, the patient's representative (if any), and the patient's primary caregiver(s); This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the clinical record contained the contact information for the patient's representative and/or patient's primary caregiver for three out of seven sampled patients (Patient 1, 2, and 7). This failure had the potential for the patient's care needs to not be identified, addressed and care plan updated with the patient's representative and/or patient's primary caregiver. A review of Patient 7's clinical records indicated Patient 7 had a start of care date with the HHA on 8/20/24 and was discharged on 9/27/24 with no diagnosis listed. A review of Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", indicated the start of care was 8/20/24 and the initial assessment by a registered nurse was completed on 8/28/24. The assessment did not include the names or contact information for Patient 7’s primary caregivers or other available support. During a concurrent interview and record review on 1/28/25 at 2 p.m. with the SC, Patient 7's comprehensive assessment titled, "Non-Oasis Start of Care", was reviewed. The SC confirmed Patient 7’s comprehensive assessment was missing information about the primary caregiver. The SC stated she was not aware the information needed to be in the clinical records. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." During a review of the agency's P&P titled, "Contents of the Clinical Record," revised July 2016 indicted, " The following information will be available in the clinical record, as applicable to care and services provided: ...his/her legal authorized representative...Name, address, and telephone number of family/caregiver and patient representative to be contacted in the event of an emergency/death." A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the Home Health Agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). Review of Patient 2's "Client Profile" indicated Patient 2's insurance provider was Alta California Regional Center, but there was no documentation of the patient's authorized representative, and the address or the telephone number of Patient 2's representative. A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, did not indicate the contact information for the patient's representative and/or patient's primary caregiver. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2 clinical record was reviewed. The SC confirmed that there was no documentation of Patient 2's authorized representative, and the address or the telephone number of the representative in Patient 2's clinical record. During a review on 1/29/25 of Patient 1's "Home Health Certification and Plan of Care" for the certification period 12/13/24 to 2/10/25 revealed no documentation of the contact information for the patient's representative and/or patient's primary caregiver. Review of Patient 1's "Client Profile" indicated he was under Alta California Regional Center, an organization that provides services to persons with developmental disabilities. There was no documentation of the patient's authorized representative, the address or the telephone number of Patient 1's representative. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated the Director of Patient Care Serivces (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer.

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 have a completed discharge summary that was sent to the primary care practitioner or other health care professional who are responsible for providing care and services to the patient after discharge from the HHA (Home Health Agency) within 5 business days of the patient's discharge for two out of seven sampled patients (Patient 6 and Patient 7). This failure had the potential to negatively impact the continuity of care for Patient 6 and Patient 7. A review of Patient 7's clinical records indicated Patient 7 had a start of care date with the HHA on 8/20/24 and was discharged on 9/27/24 with no diagnosis listed. During a concurrent interview and record review on 1/28/25 at 9:35 a.m. with the Staffing Coordinator (SC), Patient 7's clinical record was reviewed. The SC confirmed Patient 7 did not have a discharge summary in their clinical record. A review of the agency's policy and procedure titled, "Discharge Summary," revised October 2008, indicated, " Each patient discharged from a service and from the organization will have a written discharge summary filed in the clinical record....Each clinician who provides care will complete a discharge summary at the time his/her discipline is discharged...The discharge summary and other relevant clinical record documents will be completed and submitted in the medical record." During a concurrent interview and record review on 1/28/25 at 3:06 p.m. with Director of Patient Care Services (DPCS) 1, Patient 6's clinical record was reviewed. DPCS 1 confirmed Patient 6 was discharged from the agency on 1/1/25. DPCS 1 confirmed a discharge summary had not been completed and indicated one should have been done.

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 home health agency (HHA) failed to ensure clinical records were completed timely for one out of seven sampled patients (Patient 4). This failure had the potential for Patient 4's treatment and care needs to be not communicated and unmet causing possible adverse events. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures). A review of Patient 4's clinical records indicated two "not started" skilled nursing visit notes dated 10/21/24 and two "not started" skilled nursing visit notes dated 10/28/24. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the Staffing Coordinator (SC), Patient 2's clinical record was reviewed. The SC confirmed that Patient 2 had a total of four "not started" skilled nursing visit notes which were dated 10/21/24 and 10/28/24. A review of the agency's policy and procedure (P&P) titled, "ENTRIES INTO THE CLINICAL RECORDS", revised 7/2016, indicated, "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...6. Entries into the clinical record will be made on the day care is provided to the patient. All documentation will be turned into the office at the end of the workday." A review of the agency's document titled, "Policy for Home Health Charting in [name of agency's electronic health record system]", dated 6/20/22, indicated, "Effective immediately, charting for your home health visits must be entered in [name of agency's electronic health record system] every week by 10 am on the Monday following the work week..."

Personnel qualifications CFR(s): 484.115 Condition of participation: Personnel qualifications. HHA staff are required to meet the following standards: This CONDITION is not met as evidenced by: Based on interview and record review, it was determined the Home Health Agency (HHA) failed to have a qualified Administrator (G1053) and failed to ensure Licensed Vocational Nurses who furnished services were under the supervision of a qualified registered nurse (G1060). The extent and cumulative effect of these systemic practices resulted in agency staff not meeting professional standards and not practicing in their scope of practice.

Administrator CFR(s): 484.115(a) Standard: Administrator, home health agency. (1) For individuals that began employment with the HHA prior to January 13, 2018, a person who: (i) Is a licensed physician; (ii) Is a registered nurse; or (iii) Has training and experience in health service administration and at least 1 year of supervisory administrative experience in home health care or a related health care program. (2) For individuals that begin employment with an HHA on or after January 13, 2018, a person who: (i) Is a licensed physician, a registered nurse, or holds an undergraduate degree; and (ii) Has experience in health service administration, with at least 1 year of supervisory or administrative experience in home health care or a related health care program. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to have a qualified Administrator for a census of 19. This failure negatively impacted the day-to-day operations of the agency and resulted in the agency' s inability to remain in compliance with Federal Regulations. The agency failed to provide documentation that the administrator met the qualifications. The Administrator of the home health agency (HHA) for individuals that began employment with the HHA prior to January 13, 2018, a person who: (i) Is a licensed physician; (ii) Is a registered nurse; or (iii) Has training and experience in health service administration and at least 1 year of supervisory administrative experience in home health care or a related health care program. Review of the Administrator's resume indicated she was the Staffing Coordinator for the agency from August 2015-July 2017, then she was the Staffing Manager and Recruiter for the agency from July 2017 to September 2018 and then Long-Term Care Lead and School Services Manager for the agency for the agency from October 2018 until she was appointed the agency's Administrator. The Department did not receive documentation of when the Administrator was appointed by the Governing Body. There was no documentation the Administrator met the qualifications for the HHA's Administrator. The Administrator was not available to be interviewed during the Recertification Survey. Review of the agency's policy and procedure (P&P) titled, "Appointment of Administrator, revised October 2008 indicated, "Have the education and/or experience appropriate to fulfill his/her responsibilities and have knowledge of service systems in the community served by the organization...The Governing Body will appoint the Executive Director/Administrator through the standard recruitment and selection process, including, but not limited to...Verification of educational preparation.... Verification of experience and previous work history." Review of the agency's P&P titled, "Governing Body," revised 2008, indicated, "The Governing Body will appoint a qualified Executive Director/Administrator who will be responsible for day-to-day management of the organization..."

Licensed Practical (Vocational) Nurse CFR(s): 484.115(e) Standard: Licensed practical (vocational) nurse. A person who has completed a practical (vocational) nursing program, is licensed in the state where practicing, and who furnishes services under the supervision of a qualified registered nurse. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure Licensed Vocational Nurses (LVN) who furnished services was under the supervision of a qualified registered nurse for four out of seven sampled patients (Patient 1, 6, 2, and 4). This failure had the potential for the patients care needs, including frequency of visits and services provided, to be unmet, causing possible adverse events. A review of Patient 2's clinical records indicated Patient 2 had a start of care date with the home health agency (HHA) on 10/14/24 and had diagnoses that included diabetes mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing). A review of Patient 2's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/14/24, revealed that Patient 2 was planned to have two times a day skilled nursing visits. A review of Patient 2's clinical records indicated LVNs were making the daily visits for Patient 2. A further review of Patient 2's clinical record did not indicate that supervisory visits for the LVNs by an RN were being done. A review of Patient 4's clinical records indicated Patient 4 had a start of care date with the HHA on 1/18/18 and had diagnoses that included diabetes mellitus, cerebral palsy (a group of conditions that affect movement and posture), and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures). A review of Patient 4's plan of care titled, "HOME HEALTH CERTIFICATION AND PLAN OF CARE", dated 12/12/24, revealed that Patient 4 was planned to have two times a day, five days in a week, skilled nursing visits. A review of Patient 4's clinical records indicated LVNs were making the visits for Patient 4. A further review of Patient 4's clinical record did not indicate that supervisory visits for the LVNs by an RN were being done. During a concurrent interview and record review on 1/29/25 at 10:50 a.m. with the SC, Patient 2 and Patient 4's clinical record was reviewed. The SC confirmed that Patient 2 and Patient 4's clinical records did not indicate that supervisory visits for the LVNs doing the skilled nursing visits by an RN were being done. During a review of the agency's policy and procedure (P&P) titled, "Supervisory Visits," undated, indicated, "The registered nurse or therapist must conduct supervisory visits to the patient’s residence at regular intervals... The frequency of supervisory visits will be based on the patient's needs after the treatment plan is established. They must be conducted at least every 62 days, and every two (2) weeks for home health aide services for a patient in conjunction with skilled nursing services and a written plan of treatment.... The registered nurse will be responsible for...Supervision of all services provided for in the plan of treatment. If the patient receives skilled care, the registered nurse will make an on-site visit to the patient's home no less frequently than every two weeks. At least once/month, the clinician should be present. The registered nurse will provide the initial assessment of the patient and the care environment.... When a licensed vocational nurse is delegated supervision of services that are provided in conjunction with skilled nursing services, a registered nurse will make the on-site supervisory visit to the patient’s home at least every three months, to observe the patient and patient care environment. When a licensed vocational nurse is delegated supervision of personal care services, a registered nurse will retain responsibility for supervision of licensed and unlicensed personnel providing such services." "Supervisory visits and overall supervision will be documented in the clinical record...Supervisory visits will be documented on a supervisory visit form. Ongoing supervision will be documented within the plan of treatment, home health aide assignment sheet, and clinical notes." During a review of the agency's P&P titled, "Responsibilities/Supervision of Clinical Services," revised October 2008, indicated, "To ensure a process is in place for the selection of a qualified individual for overseeing all clinical care and services." The Director of Patient Care Services and Nurse Supervisor will monitor the care and service provided by organization personnel...Monitoring includes the review of performance improvement results, incident reports, infection reports, clinical record review results, etc. Any noted trends of individual performance will be used during the evaluation. Review of the agency's policy and procedure (P&P) titled, "Designation of Individual in Absence of Administrator," revised October 2008, indicated, "24/7 MedStaff will have an Executive Director/Administrator or designee available at all time. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services will assume the operational duties and responsibilities at 24/7 MedStaff. In the event both executives are absent, an appropriately qualified nurse will assume the responsibilities. These individuals have been identified as qualified to act on behalf of the Executive Director/Administrator in his/her absence." During a review of Patient 1's "Home Health Certification and Plan of Care," dated 12/13/24 to 2/10/25 indicated an order for Skilled Nurse (SN) visits 4 times a day. Review of Patient 1's SN visit notes revealed Licensed Vocational Nurses (LVN) were making the daily visits. Review of Patient 1's clinical record revealed no documentation supervisory visits were being made. During the review of Patient 6's "Home Health Certification and Plan of Care," dated 12/16/24 to 2/13/205 indicated an order for SN visits 4 times a day. Review of Patient 6's SN visit notes were revealed LVNs were making the daily visits. Review of Patient 6's clinical record revealed no documentation supervisory visits were being made. During an interview on 1/27/25 at 9:49 a.m. with the Staffing Coordinator (SC), she stated she had no clinical background and was not a nurse. During an interview on 1/29/25 at 9:49 a.m., with the SC, she stated Director of Patient Care Services (DPCS) 1 would not be available until after 12:30 p.m. but may not be able to answer questions at the time due to being "groggy." The SC indicated she doesn't answer clinical questions. Multiple phone calls were placed to DPCS 1 on 1/29/25 with no answer. During an interview on 1/29/25 at 1:27 p.m. with the SC, she was asked if Registered Nurse (RN) supervisory visits were done. The SC stated that was a clinical question and would need to ask DPCS 1. SC placed a telephone to DCPS 1 but there was no answer.

The following reflects the findings of the California Department of Public Health during the investigation of complaint #98456. Representing the Department of Public Health: Health Facilities Evaluator Nurse, 43247 The inspection was limited to the specific complaint investigated and does not represent the findings of a full inspection of the agency.

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 complete recertification assessments for 5 of 7 (Patient 1, Patient 2, Patient 4, Patient 5, Patient 7) sampled patients within the last 5 days of every 60 days of the Plan of Care (POC) certification period. This failure had the potential for patents' needs to not be identified resulting in patients' needs not being met. A review of Patient 1's "Home Health Certification and Plan of Care (POC)" for certification periods 2/4/23 to 5/4/23 and 5/5/23 to 7/3/23, indicated Patient 1 had a Start of Care (SOC) date with the HHA on 1/18/18 for diagnoses including diabetes (too much sugar in the blood), cerebral palsy (congenital disorder of movement, muscle tone, or posture), and epilepsy (seizure disorder). A review of Patient 1's clinical record indicated Patient 1 had recertification assessments on 2/12/23 and 4/12/23. A review of Patient 2's POC for certification period 2/18/23 to 5/18/23 and 5/19/23 to 7/17/23, indicated Patient 2 had a SOC date with the HHA on 6/14/16 for diagnosis of anoxic brain damage (brain injury caused by lack of oxygen to the brain). A review of Patient 2's clinical record indicated Patient 2 had a recertification assessment on 4/16/23. A review of Patient 4's POC for certification period 12/11/22 to 2/8/23, indicated Patient 4 had a SOC date with the HHA on 7/1/18 for diagnoses including diabetes and Down syndrome (a genetic chromosomal disorder causing developmental and intellectual delays). A review of Patient 4's clinical record indicated Patient 4 had a recertification assessment on 12/5/22. No further recertification assessments documented in the clinical record. A review of Patient 5's POC, for certification periods 2/14/23 to 5/14/23 and 5/15/23 to 7/13/23, indicated Patient 5 had a SOC date with the HHA on 1/18/18 for diagnoses including diabetes and intellectual disabilities (limitations in cognitive functioning). A review of Patient 5's clinical record indicated Patient 5 had a recertification assessment on 4/12/23. A review of Patient 7's POC, for certification periods 12/16/22 to 2/13/23 and 2/14/23 to 5/14/23, indicated Patient 5 had a SOC date with the HHA on 1/16/18 for diagnoses including diabetes and epilepsy. A review of Patient 7's clinical record indicated Patient 7 had recertification assessments on 2/4/24, 4/4/23, and 4/24/23. During a telephone interview on 5/17/23 at 3:44 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated the recertification assessments are done every 60 days and are up to date. During a telephone interview and record review on 5/19/23 at 10:37 a.m. with the DPCS, the DPCS acknowledged that Patient 1's recertification assessments done on 2/12/23 and 4/12/23 were not done within the last 5 days of the certification periods 2/4/23 to 5/4/23 and 5/5/23 to 7/3/23. The DPCS acknowledged that Patient 2's recertification assessment done on 4/16/23 was not done within the last 5 days of certification period 2/18/23 to 5/18/23. The DPCS stated, "It is a concern of mine, the POC date does not sync up with the recertification date." The DPCS acknowledged that this was not in compliance. During a telephone interview and record review on 5/25/23 at 11:14 a.m. with the DPCS, the DPCS acknowledged that Patient 5's recertification assessment done on 4/12/23 was not done within the last 5 days of the certification period 2/14/ 23 to 5/14/23. The DPCS acknowledged that Patient 7's recertification assessments done on 12/4/23, 2/4/23, 4/4/23 and 4/24/23, were not done within the last 5 days of certification periods 12/16/22 to 2/13/23 and 2/14/23 to 5/14/23. The DPCS stated that several recertification assessments have not been done within the last 5 days of the POC certification period. During a telephone interview and record review on 5/31/23 at 8:49 a.m. with the DPCS, the DPCS acknowledged that Patient 4 did not have any recertification assessments completed after 12/5/23. A review of the HHA policy titled "Home Health Recertification Policy," not dated, indicated "...The purpose of this policy is to establish guidelines for the recertification process in home health care, ensuring that patients continue to receive appropriate and necessary services...The recertification process will comply with the guidelines and regulations set forth by Medicare and Medicaid programs...The recertification process will be initiated within the timeframe specified by Medicare/Medicaid regulations...typically occurring every 60 days...A comprehensive assessment will be conducted by a qualified healthcare professional, such as a registered nurse or therapist, to evaluate the patient's current condition, progress, and ongoing needs...The patient's care plan will be reviewed and updated based on the assessment findings..."

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to provide an accurate Plan of Care (POC) for patients when; 1. 5 of 7 sampled patients (Patient 1, Patient 2, Patient 5, Patient 6, Patient 7) had POCs with certification periods greater than 60 days and; 2. 7 of 7 sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, Patient 7) did not have a current POC or did not have a POC signed by the physician. This failure had the potential for patients' care needs to not be evaluated timely and care needs to be unmet. Findings: 1. A review of Patient 1's clinical record indicated a POC with certification period 2/4/23 to 5/4/23. A review of Patient 2's clinical record indicated a POC with certification period 2/18/23 to 5/18/23. A review of Patient 5's clinical record indicated a POC with certification period 2/14/23 to 5/14/23. A review of Patient 6's clinical record indicated a POC with certification period 3/1/23 5/29/23. A review of Patient 7's clinical record indicated a POC with certification period 2/14/23 to 5/14/23. During a telephone interview and record review on 5/19/23 at 10:37 a.m. with the Director of Patient Care Services (DPCS), reviewed multiple patient records with certification periods greater than 60 days. The DPCS acknowledged that most of the patients have a POC with certification periods greater than 60 days. The DPCS stated she has been completing the recertification assessments every 60 days. The DPCS stated, "It is a concern of mine that the POC certification dates do not sync up with the recertification date." The DPCS stated that many of the patient's charts reflected a POC that was out of compliance. During a telephone interview on 5/19/23 at 11:43 a.m. with the Regional Recruiting Manager (RM), the RM acknowledged that the POC certification periods for multiple patients are greater than 60 days. The RM stated that problem was supposed to have been fixed, but the person working on that has left the company. The RM stated the certification periods have not been fixed and do not match the recertification assessments. During a telephone interview and record review on 5/25/23 at 11:14 a.m. with the DPCS, The DPCS acknowledged several patients have certification periods greater than 60 days. The DPCS acknowledged that Patient 1's POC certification period 2/4/23 to 5/4/23, Patient 2's certification period 2/18/23 to 5/18/23, Patient 5's certification period 2/14/23 to 5/14/23, Patient 6's certification period 3/1/23 to 5/29/23, and Patient 7's POC certification period 2/14/23 to 5/14/23, are greater than 60 days. The DPCS stated that POC certification periods have been incorrect due to a system problem. 2. A review of Patient 1's clinical record indicated POC with certification period 2/4/23 to 5/4/23. A review of Patient 2's clinical record indicated POC with certification periods 2/18/23 to 5/18/23. A review of Patient 3' clinical record indicated a POC with certification period 4/14/23 to no end date. A review of Patient 4's clinical record indicated a POC with certification period 12/11/22 to 2/8/23 and no further POCs. A review of Patient 5's clinical record indicated POC with certification period 2/14/23 to 5/14/23. A review of Patient 6's clinical record indicated POC with certification period 3/1/29 to 5/29/23. A review of Patient 7's clinical record indicated a POC with a certification period from 2/14/23 to 5/14/23 and no current POC. During a telephone interview and record review on 5/25/23 at 11:14 a.m. with the DPCS, the DPCS also acknowledged Patient 7 does not have a current POC. The DPCS stated that POC certification periods have been incorrect due to a system problem. During a telephone interview and record review on 5/31/23 at 8:49 a.m. with the DPCS, the DPCS stated that the POCs are faxed to the physician for review and signature. The physician signed the POC, emailed it back and it was scanned into the documents section of the electronic record. The POCs were emailed by physicians to a former employee and may not be in the clinical record. The HHA is trying to access the former employees email inbox to obtain documents. The DPCS acknowledged that Patient 1's POC certification period 2/4/23 to 5/4/23, Patient 2's POC certification period 2/18/23 to 5/18/23, Patient 3's POC certification period 4/14/23 to no end date, Patient 5's POC certification period 2/14/23 to 5/14/23, Patient 6's POC certification period 3/1/23 to 5/29/23, and Patient 7's POC certification period 2/14/23 to 5/14/23 did not have documents scanned into record indicating that physicians had signed the POCs. The DPCS also acknowledged that Patient 4 did not have a POC in the clinical record after the certification period 12/11/23 to 2/8/23. A review of the HHA's policy titled "Home Health Plan of Care Policy." not dated, indicated "...The purpose of this policy is to establish guidelines for the development, implementation, and documentation of a comprehensive Home Health Plan of Care (POC). The POC serves as a roadmap for delivering high-quality, individualized care to patients in their homes. It outlines the goals, interventions. and expected outcomes, ensuring that all team members are aligned in providing consistent and effective care...the POC should comply with all applicable laws, regulations, and accreditation standards...The POC should be documented in the patient's electronic health record (EHR) or a designated care management system, and it should be accessible to all authorized healthcare providers involved in the patient's care..." A review of the HHA's policy titled "Home Health Recertification Policy," not dated, indicated "...The purpose of this policy is to establish guidelines for the recertification process in home health care, ensuring that patients continue to receive appropriate and necessary services, and that the eligibility for continued care is regularly assessed and documented...Recertification criteria: a. Medicare/Medicaid Guidelines: The recertification process will comply with regulations ser forth by Medicare and Medicaid programs...Physician Order: A physician's order will be required for recertification, indicating the need for continued home health services and outlining the specific services to be provided... Recertification Process: a. Timeframe: The recertification process will be initiated within the timeframe specified by Medicare/Medicaid regulations or the patient's insurance coverage guidelines, typically every 60 days...The recertification process will involve collaboration with the patient's attending physician to review the assessment results, discuss any changes in the patient's condition or treatment plan, and obtain a new physician's order for continued services...All recertification activities, including the assessment, care plan updates, physician collaboration, and new orders, will be accurately and promptly documented in the patient's electronic health record (EHR) or a designated care management system..."

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure complete nursing notes were in the clinical record for 4 of 7 sampled patients (Patient 1, Patient 3, Patient 6, Patient 7). This failure had the potential to cause miscommunication among the patients' nursing staff and not provide continuity of care to the patients. Findings: A review of Patient 1's "Home Health Certification and Plan of Care (POC)," for certification period 2/4/23 to 5/4/23, indicated Patient 1 had a Start of Care (SOC) date with the HHA on 1/18/18 for diagnoses including diabetes (too much sugar in the blood), cerebral palsy (congenital disorder of movement, muscle tone, or posture), and epilepsy (seizure disorder). Patient 1's POC indicated orders for Skilled Nurse (SN) 2 times a day, 5 days a week. A review of Patient 3's POC, for certification period starting 4/14/23, indicated Patient 3 had a SOC date with the HHA on 4/14/23 for diagnoses of diabetes. Patient 3"s POC indicated orders for SN 2 times a day, 7 days a week. A review of Patient 6's POC, for certifications period 3/1/23 to 5/29/23, indicated Patient 6 had a SOC date with the HHA on 3/16/20 for diagnoses including constipation, intellectual disabilities (limited mental functioning), and epilepsy. Patient 6's POC indicated orders for SN 2 times a week. A review of Patient 7's POC, for certification period 2/14/23 to 5/14/23, indicated Patient 5 had a SOC date with the HHA on 1/16/18 for diagnoses including diabetes and epilepsy. Patient 7's POC indicated orders for SN 3 times a day, 7 days a week. A review of Patient 1's "Activity Schedule" for May 2023 indicated missing visit notes for 5/3/23, 5/4/23, 5/5/23, 5/10/23, 5/12/23, 5/15/23, 5/17/23, 5/18/23, and 5/19/23. A review of Patient 3's "Activity Schedule" for April 2023 and May 2023 indicated missing visit notes for 4/15/23 to 4/30/23 and 5/13/23, 5/14/23, 5/17/23, and 5/19/23. A review of Patient 6's "Activity Schedule" for April 2023 and May 2023 indicated missing visit notes for 4/7/23, 5/5/23, 5/8/23, 5/12/23, 5/15/23, and 5/19/23. A review of Patient 7's "Activity Schedule" for April 2023 indicated a missing visit note for 4/19/23. During a telephone interview on 5/17/23 at 10:55 a.m. with Licensed Nurse (LN) 1, LN 1 stated she electronically charts her nursing visit within 24 hours of visit. During a telephone interview on 5/17/23 at 11:14 a.m. with LN 2, LN 2 stated she typically charts her visits by the end of the day within 24 hours which is the HHA policy. During a telephone interview on 5/17/23 at 11:44 a.m. with LN 4, LN 4 stated Patient 3, a new patient, had not been entered into the electronic record system and was not able to be charted on in the electronic record for about 3 weeks. LN 4 stated she charted vital signs and diabetic information on paper and left in a binder at the home. LN 4 stated she was not able to chart any specific patient information into the electronic record. LN 4 stated she had notified the schedulers, but they were unable to correct. LN 4 stated that other providers did not have good access to Patient 3's information if not in the electronic record. During a telephone interview and record review on 5/17/23 at 3:44 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated she reviews the nurses' visit notes and completes them. The DPCS stated the nurses should chart within 24 hours of visit. The DPCS stated that there are problems with compliance from some of the nurses. Reviewed Patient 3's missing visit notes for April 2023 and May 2023. The DPCS stated Patient 3 was late being entered into the electronic system and was entered on 5/11/23 due to delay in obtaining information from Patient 3's case manager. The DPCS stated Patient 3's visits were charted on paper and left at the home and will be picked up and scanned into the electronic record. During a telephone interview and record review on 5/19/23 at 10:37 a.m. with the DPCS, the DPCS acknowledged that Patient 1, Patient 3, Patient 6, and Patient 7 had missing complete nurse's notes. The DPCS stated nurses should be charting within 24 hours of visit according to the HHA policy. A review of the HHA policy titled "Policy: Documentation Requirements," updated 9/8/20, indicated "...To ensure proper documentation of health care services and items provided to patients of [HHA]...The health care record provides the basis for planning patient care and continuity of that care, and its accuracy is critical to patient safety and the best outcomes...Document in a timely manner, within 48 hours of your visit..."

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to notify the patients' physicians of missed visits for 3 of 7 (Patient 1, Patient 5, Patient 7) sampled patients. This failure caused physicians to be unaware of missed visits and had the potential for continuity of care to be disrupted. A review of Patient 1's "Home Health Certification and Plan of Care (POC)," for certification period 2/4/23 to 5/4/23, indicated Patient 1 had a Start of Care (SOC) date with the HHA on 1/18/18 for diagnoses including diabetes (too much sugar in the blood), cerebral palsy (congenital disorder of movement, muscle tone, or posture), and epilepsy (seizure disorder). Patient 1's POC indicated orders for Skilled Nurse (SN) 2 times a day, 5 days a week. A review of Patient 5's POC, for certification period 2/14/23 to 5/14/23, indicated Patient 5 had a SOC date with the HHA on 1/18/18 for diagnoses including diabetes and intellectual disabilities (limited mental functioning). Patient 5's POC indicated orders for SN 4 times a day, 5 days a week and 3 times a day for 2 times a week. A review of Patient 7's POC, for certification period 2/14/23 to 5/14/23, indicated Patient 7 had a SOC with the HHA on 1/16/18 for diagnoses including diabetes and epilepsy. Patient 7's POC indicated orders for SN 3 times a day, 7 days a week. A review of Patient 1's "Missed Visit" notes dated 3/31/23, 4/24/23, 4/25/23, and 5/2/23, indicated "...Physician Office Notified: No..." A review of Patient 5's "Missed Visit" note dated 5/5/23, indicated "...Physician Office Notified: No..." A review of Patient 7's "Missed Visit" notes dated 4/23/23 and 4/24/23, indicated "...Physician Office Notified: No..." During a telephone interview and record review on 5/19/23 at 10:37 a.m. with the Director of Patient Care Services (DPCS), The DPCS acknowledged that Patient 1, Patient 5, and Patient 7's "Missed Visit" notes do not indicate that the physician was notified of the missed visits. The DPCS stated the expectation is the physician would be notified by fax of any missed visit, no matter the reason for the missed visit. A review of the HHA 's policy titled "Home Health Missed Visit or Shift Policy," not dated, indicated "...The purpose of this policy is to establish guidelines for addressing missed visits or shifts by home health staff, ensuring timely and appropriate action to minimize disruptions in patient care and maintain the continuity of services...The agency should communicate the revised schedule or any changes to the patient, their family/caregiver, and other relevant healthcare professionals..." A review of the HHA's policy titled "Home Health Physician Notification Policy," not dated, indicated "...The purpose of this policy is to establish guidelines for timely and effective communication between the Home Health agencies and the attending physicians regarding changes, updates, and significant events related to the patient's care. This policy ensures that attending physicians are promptly informed of any relevant information that may impact the patient's health or the plan of care...Updates or modifications to the patient's treatment plan, care interventions, or goals should be communicated to the attending physician for their input and approval...All notifications to attending physicians should be made in a timely manner, ensuring that the physician receives the information promptly and can provide necessary input or instructions..."

The following reflects the findings of the California Department of Public Health during a RECERTIFICATION SURVEY conducted 3/8/22 through 3/11/22. Representing the Department of Public Health: Health Facilities Evaluator Nurse (HFEN), 32525 HFEN, 43247 The agency reported 2 unduplicated annual admissions. The patient sample size was 7 and 3 home visits were conducted. The Department was unable to substantiate a violation of the regulations.

The following reflects the findings of the California Department of Public Health during a RECERTIFICATION SURVEY conducted 3/8/22 through 3/11/22. Representing the Department of Public Health: Health Facilities Evaluator Nurse (HFEN), 32525 HFEN, 43247 The agency reported 2 unduplicated annual admissions. The patient sample size was 7 and 3 home visits were conducted.

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 complete comprehensive assessments within the last 5 days of every 60 days for 2 of 7 sampled Patients (Patient 4 and Patient 5). This failure had the potential for care needs to not be identified for Patient 4 and Patient 5. Findings: A review of Patient 4's "Client Profile" indicated he had a start of care date with the HHA on 10/4/18. His diagnoses included diabetes mellitus (too much sugar in the blood) and hypertension (high blood pressure). A review of Patient 5's "Client Profile" indicated she had a start of care date with the HHA on 1/10/15. Her diagnoses included spastic quadriplegia cerebral palsy (difficulty in controlling movements in the arms and legs) and a tracheostomy (an opening surgically created through the neck into the windpipe to allow access to a breathing tube). A review of Patient 4's clinical record indicated he had comprehensive assessments completed for recertification for home health services on 3/24/21, 5/26/21, and 7/2/21. A comprehensive assessment for recertification was initiated on 1/24/22, but not completed. It was electronically signed by the Director of Patient Care Services (DPCS) on 1/24/22. A review of Patient 5's clinical record indicated she had comprehensive assessments completed for recertification for home health services on 3/4/21, 4/21/21, and 9/13/21. A comprehensive assessment, dated 12/29/21, was not completed. During an interview on 3/9/22 at 12:36 p.m. with the Office Manager (OM), reviewed that Patient 5's comprehensive assessment in the clinical record, dated 12/29/21, was not completed. The OM acknowledged that the comprehensive assessment for recertification for Patient 4, initiated on 1/24/22, was not completed but was signed by the DPCS on 1/24/22. During an interview on 3/10/22 at 10:28 a.m. with the DPCS, the DPCS stated she does the recertification assessments for patients. Recertification assessments are done every sixty days. She completes the recertification assessments within one week before the sixty days is reached. The DPCS acknowledged that the recertification assessment for Patient 4, dated 1/24/22, was not complete, but that she did electronically sign it. She stated it should have been completed so that the care plan would be personalized and updated. A review of the agency's policy titled "Ongoing Assessments," revised 7/19, indicated "...The scope and intensity of ongoing assessments will be determined by the patient's diagnoses, condition, desire for care, response to previous care, and the care setting...Based on the findings of the reassessment, additional orders will be generated and forwarded to the physician for signature(s)…"

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure a discharge assessment and discharge summary was completed for 2 of 7 sampled patients (Patient 6 and Patient 7). This failure had the potential to negatively impact the continuity of care for Patient 7 and Patient 6's clinical record was incomplete. A review of Patient 7's Plan of care (POC) dated 1/30/21 through 4/1/21 indicated he was admitted 4/16/20 with a diagnosis of cerebral palsy (congenital disorder of movement, muscle tone or posture) and needed assistance with feeding via a stomach tube, medication administration, monitoring of his health condition and ensuring safety was maintained. The Skilled Nurse (SN) was to visit 8 hours a day for 5 days during no school and 40 hours a week during school. A further review of Patient 7's record reflected an assessment completed on 4/16/21. An interview conducted with the Office Manager (OM) on 3/9/22 at 3 p.m., to establish if Patient 7 was currently being seen by the agency, the OM stated the patient was discharged on 4/1/21 when the nurse who was assigned to the patient was no longer available. The OM stated the family was offered a replacement but they declined. The OM stated she communicated to the former Director of Nursing Services (DPCS) about the challenges of getting a nurse for the patient and provided an email conversation dated 5/3/21 from Patient 7's case manager seeking to establish if the agency was still providing care for the patient. The OM had indicated the patient was discharged on 4/1/21. The OM stated she was not sure why an assessment was completed on 4/16/21 if the Patient had been discharged on 4/1/21. The OM stated the former DPCS had resigned on 4/8/21 and she did not complete the discharge assessment. During an interview and concurrent record review with the current DPCS on 3/11/22 at 11:27 a.m., she stated she was not able to determine where Patient 7 went from reviewing the record because it was not documented. The DPCS stated if Patient 7 was discharged, the clinical record should contain a discharge assessment, a discharge summary and a physician order to discharge or transfer the patient. A review of the home health agency's policy titled "Discharge Summary," revised 7/19, indicated "...Each patient discharged from a service and from the organization will have a written discharge summary filed in the clinical record... The discharge summary and other relevant clinical record documents will be completed and submitted in the medical record..." Findings: A review of Patient 6's "Client Profile" indicated Patient 6 had a start of care on 5/22/19. He had multiple diagnoses including diabetes mellitus (too much sugar in the blood) and hypertension (high blood pressure). A review of Patient 6's clinical record, reflected a "Home Health Certification and Plan of Care," with certification period 11/26/20 to 3/10/21, that indicated he had orders for Skilled Nurse (SN) services four times a day. A review of a "Physician Order," dated 3/10/21, for Patient 6 indicated "Patient dc [discharge] from HH [Home Health] services due to death caused by complications of seizures 3/9/2021. Care team notified." A record review of "Non-oasis discharge" (an assessment tool), dated 3/10/21, for Patient 6 indicated "...Patient was admitted to the hospital on 3/8/2021 d/t [due to] the home care staff found the patient unconscious. Patient was admitted to the hospital for strokes. Patient is dc from HH services due to unforeseen death d/t complication of stroke. Agency notified on 3/10/2021. Care team informed..." A discharge summary for Patient 6 was not found in his clinical record. During a telephone interview on 3/10/22 at 10:28 a.m. and a subsequent telephone interview on 3/11/22 at 11:27 a.m. with the Director of Patient Care Services (DPCS), she acknowledged that there was not a discharge summary in Patient 6's clinical record. She stated, "Should have discharge summary, don't see one in the chart." She stated the discharge summary should be completed the same day as the discharge or within 24 hours of discharge. A review of the home health agency's policy titled "Discharge Summary," revised 7/19, indicated "...Each patient discharged from a service and from the organization will have a written discharge summary filed in the clinical record... The discharge summary and other relevant clinical record documents will be completed and submitted in the medical record..."

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 Home Health Agency (HHA) failed to ensure the plan of care was updated every 60 days (G572), the staff followed the physician ordered services (G578), the staff notified the physician when the services ordered were not provided (G590). The agency failed to ensure patient care was coordinated (G608) and home visits were provided per the Plan of Care (G614). The agency failed to ensure medication profiles were accurate and medications in the home were current (G616). The extent and cumulative effect of these systemic practices resulted in the agency's inability to ensure that the patients' nursing needs were coordinated and provided as ordered.

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 update the Plan of Care (document that includes HH needs, services and the frequency of these services according to a physician's order) to reflect current physician orders every 60 days for 3 of 7 sampled Patients (Patient 4, Patient 5, Patient 6). This failure had the potential for the patients care needs, including frequency of visits and services provided, to be unmet causing possible adverse events. Findings: A review of Patient 4's "Client Profile" indicated he had a start of care with the HHA in on 10/4/18. Patient 4 had multiple diagnoses including diabetes mellitus (too much sugar in the blood) and hypertension (high blood pressure) A review of Patient 5's "Client Profile" indicated she had a start of care with the HHA on 1/10/18. Patient 5's diagnoses included spastic quadriplegia, cerebral palsy (difficulty in controlling movements in the arms and legs) and a tracheostomy (an opening surgically created through the neck into the windpipe to allow access to a breathing tube). A review of Patient 6's "Client Profile" indicated he had a start of care with the HHA ion 5/22/19. Patient 6 had multiple diagnoses including diabetes mellitus and hypertension. A review of Patient 4's "Home Health Certification and Plan of Care," included certification periods for 3/26/21 to 5/24/21,5/23/21 to 8/22/21, and 2/19/22 to 4/19/22. The Plan of Care for periods 3/26/21 to 5/24/21 and 5/23/21 to 8/22/21, indicated orders for SN (skilled nursing- services provided by a licensed nurse) were twice daily. The Plan of Care for the period 2/19/22 to 4/19/22, did not contain orders for disciplines (types of services) and treatments (SN services for diabetic management including monitoring blood sugar and administering insulin). Patient 4's clinical record did not contain a Plan of Care for the period from 5/24/21 to 2/19/21. The certification period for 5/23/21 to 8/22/21 was greater than 60 days. A review of Patient 5's "Home Health Certification and Plan of Care" for certification periods 11/10/20 to 3/9/21, 3/10/21 to 5/8/21, and 5/9 /21 to no end date included orders signed by the RN on 8/13/21 and 3/9/22 for the following services: - SN (skilled nursing) Frequency 56-72 hours/week; - MSW (Masters of Social Work) Frequency 2 hours/month; and - HHA (home health aide) Frequency 283 hours/month The certification period 11/10/20 to 3/9/21 was greater than 60 days. The Plan of Care certification period 5/9/21 did not include an end date, but had been signed on 8/13/21 and then again on 3/9/22 by the RN (Registered Nurse) indicating a certification period greater than 60 days. A record review of Patient 6's "Home Health Certification and Plan of Care" for certification periods 8/28/20 to 11/25/20 and 11/26/20 to 3/10/21 indicated orders for SN 4 times a day. The Plan of Care certification periods were greater than 60 days. During an interview on 3/9/22 at 12:36 p.m. with the Office Manager (OM), she acknowledged that the certification period date of 5/9/21 for Patient 5's "Home Health Certification and Plan of Care" was incorrect. The OM stated there was no current plan of care with physician orders because the comprehensive assessment (a tool to evaluate a patient's complete health status) had been initiated on 12/29/21 but not completed. The comprehensive assessment would have been a trigger for the Plan of Care to be completed. During an interview on 3/9/22 at 2:08 p.m. with the OM, she acknowledged that the certification periods for Patient 6's Plan of Care were greater than 60 days. During a telephone interview on 3/10/22 at 10:28 a.m. and a subsequent telephone interview on 3/11/22 at 11:27 a.m. with the Director of Patient Care Services (DPCS), she stated the "Home Health Certification and Plan of Care" is completed every 60 days or as needed for a change in condition. The DPCS stated the comprehensive assessments for recertification should be done by the Supervising RN every 60 days or as needed. The DPCS stated the Plan of Care is derived from the comprehensive assessment. If the comprehensive assessment was not done, the Plan of Care was not able to be completed. The DPCS acknowledged that Patient 4, Patient 5, and Patient 6's plans of care were not updated every 60 days. Patient 4's Plan of Care for 2/19/22 to 4/19/22, did not contain orders for disciplines and treatments. A review of the agency's policy titled "Care Planning Process," revised 7/19, indicated "... The plan of treatment will be revised as frequently as deemed necessary by the clinician, based on the ongoing assessments of the patient. Revision dates will be noted on the plan of treatment...The plan of treatment will be reviewed and updated by the attending personnel at least every 62 days..."

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to follow the physician orders when visits were not completed as ordered for 3 of 7 sampled patients (Patient 1, Patient 5 and Patient 7). This failure resulted in Patient 5 not receiving services ordered by the physician and Patient 7 failed to receive the hours of nursing care ordered by the physician and Patient 1 had the potential to have missed a dose of insulin causing possible adverse events. A review of Patient 7's Plan of care (POC) dated 1/30/21 through 4/1/21 indicated he was admitted 4/16/20 with a diagnosis of cerebral palsy (a congenital disorder of movement, muscle tone or posture) and needed assistance with feeding via a stomach tube, medication administration, monitoring of his health condition and ensuring safety was maintained. The Skilled Nurse (SN) was to visit 40 hours per week. A further review of Patient 7's clinical record indicated only one visit was completed to assess him on 1/30/21 from 10-11 a.m. and no visit was done on 1/31/21. There were no documented visits in February 2021. In March 2021, 40 hours were provided on 3/14/21 through 3/18/21 which was the only week he received the service. There was no documentation to establish why Patient 7 's visits were not completed as ordered. During an interview and concurrent record review on 3/11/22 at 11:27 a.m. with the Director of Patient Care Services (DPCS), she validated Patient 7's plan of care physician orders was not followed during the period 1/30/21 through 4/1/21 and she could not determine why it was not documented in his clinical record. A review of the agency policy titled "Monitoring Patient's Response/Reporting To Physician," revised 7/19, indicated "...Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient..." A review of the agency's policy titled "Skilled Nursing Services Provided," revised 7/19, indicated "...[HH agency] shall provide the services of registered nurses and licensed vocational nurses in sufficient quality and quantity to meet the needs of the patients accepted for care." Findings: A review of Patient 1's Client Profile indicated she had a start of care with the HHA on 7/1/18. Her diagnoses included diabetes mellitus (a disease that causes too much sugar in the blood) and Down syndrome (a genetic disorder that causes developmental and intellectual delays). A review of Patient 1's "Home Health Certification and Plan of Care," for certification period 2/14/22 to 4/14/22, indicated she was to receive Skilled Nursing (SN) visits twice daily, seven days a week for blood sugar monitoring and insulin administration. A review of Patient 1's "Activity Schedule," for January 2022, indicated Patient 1 had a missed visit for SN (skilled nursing) services on 1/31/22. A review of Patient 1's "Missed Visit" note for SN services, dated 1/31/22, indicated "Reason- Clinic Appointment...Comments-Patient had lab works appointment @ [medical clinic] this morning....Physician Office Notified: No..." During a telephone interview on 3/10/22 at 10:28 a.m. with the Director of Patient Care Services (DPCS), she stated that visits are color coded in the "Activity Schedule" and red indicates a missed visit. The DPCS reviewed a "Missed Visit" note, dated 1/31/22, for Patient 1. The DPCS acknowledged that the physician was not notified of the missed visit on 1/31/22. She stated the expectation is that the physician would be notified if the nurse is unable to make the visit as scheduled so that the physician is aware and that treatment can be changed if needed. A review of the agency policy titled "Monitoring Patient's Response/Reporting To Physician," revised 7/19, indicated "...Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient..." A review of Patient 5's "Client Profile" indicated she had a start of care date with the HHA on 1/10/15. Her diagnoses included spastic quadriplegia cerebral palsy (difficulty in controlling movements in the arms and legs) and a tracheostomy (an opening surgically created through the neck into the windpipe to allow access to a breathing tube). A review of Patient 5's "Home Health Certification and Plan of Care," for certification periods 11/10/20 to 3/9/21, 3/10/21 to 5/8/21, and 5/9/21 to end date not included, but signed by RN (Registered Nurse) on 8/13/21 and 3/9/22, indicated orders that included: SN (skilled nursing) Frequency 56-72 hours/week MSW (Masters of Social Worker) Frequency 2 hours/ month HH Aide (home health aide) Frequency 283 hours/ month A review of Patient 5's "Activity Schedule," for 1/22, 2/22 and 3/22, indicated Patient 5 received SN visits of eight hours in length, on Monday through Saturday. Visits were not scheduled for Sundays. These visits provided 48 hours per week of SN care. During an interview on 3/8/22 at 9:56 a.m. with the Office Manager (OM), she stated the agency only provides LVN or RN services. The agency does not provide HH Aide (Home Health Aide to assist patients with bathing, dressing and other activities of daily living) or MSW (provide emotional support and resources) services. During an interview on 3/9/22 at 12:36 a.m. with the OM, she acknowledged that Patient 5's Plan of Care, dated 5/9/21, indicated Patient 5 was to receive MSW services and HH Aide services. The OM stated that the agency does not offer these services and they were not provided to Patient 5. During a telephone interview on 3/10/22 at 10:28 a.m. and a subsequent telephone interview on 3/11/22 at 11:27 a.m. with the Director of Patient Care Services (DPCS), reviewed Patient 5's Plan of Care, dated 5/9/21, indicating she had MSW and HH Aide services ordered in addition to SN services. Reviewed that Patient 5 only received 48 hours a week of SN services, instead of 56-72 hours as ordered. The DPCS stated that if services are not provided, they should not be in the Plan of Care. The Plan of Care should be changed. She stated that these services were not provided, likely, due to staffing issues. During a telephone interview on 3/11/22 at 9:36 a.m. with Patient 5's family member (FM), she stated the home health agency has provided SN services since 2014. She stated the nurse comes Monday through Friday from 11 p.m. to 7 a.m. The nurse on Saturday comes at 12 p.m. to 8 p.m. The FM stated there has not been nurse on Sundays. She stated she wished they would provide a nurse on Sundays. The FM provides the majority of the care needed. The FM stated that Patient 5 has not received MSW or HH Aide services. A review of the agency's policy titled "Care Planning Process," revised 7/19, indicated "...The care planning decisions will be reflected in the specific services that will be provided and the associated actions planned and implemented to meet individualized patient problems and goals..." A review of the agency's policy titled "Skilled Nursing Services Provided," revised 7/19, indicated "...[HH agency] shall provide the services of registered nurses and licensed vocational nurses in sufficient quality and quantity to meet the needs of the patients accepted for care."

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 agency failed to ensure patient care was coordinated as per facility policy "Care Coordination," for 7 of 7 sampled patients (Patient 1, 2, 3, 4, 5, 6, and 7) when there was no documented evidence in patients' clinical records that care coordination occurred. This failure had the potential to cause confusion and potentially omit or duplicate services delivered. During a review of 7 of 7 sampled patients' clinical records, there was no documentation that care was coordinated among the nursing staff, the clinical manager (DPCS), the patients and/or their care-givers. An interview conducted on 3/11/22 at 11:27 a.m., with the DPCS, she stated the agency was currently providing care for 18 patients. The DPCS stated she talked to the families during visits and the individual nurse assigned to the patient if she needed to clarify an issue. The DPCS stated she had not completed any care conference or coordinated care with the nursing staff, the patient and/or their care-givers since she was hired mid last year. The DPCS stated, "That is something we need to start doing..." A review of the agency's policy titled, 'Care Coordination' revised 7/2019 indicated in part, "Written evidence of care coordination will be recorded during the case conference and repeated in skilled nursing visit reports in the patient's clinical records ... A registered nurse will be assigned to patients receiving skilled nursing ... Care coordination will include ... Planned face-to-face conferences ... Timely documentation of coordination of care activities ... Appropriate involvement of the patient and caregivers."

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to follow the Plan of Care for scheduled visits for 2 of 7 sampled patients (Patient 1 and Patient 5). This failure resulted in the potential for Patient 1 not to receive scheduled insulin doses and Patient 5 to have fewer skilled nursing care hours than ordered. This also resulted in the agency not providing ordered services for Patient 5. Findings: A review of Patient 1's Client Profile indicated she had a start of care with the HHA on 7/1/18. Her diagnoses included diabetes mellitus (a disease that causes too much sugar in the blood) and Down syndrome (a genetic disorder that causes developmental and intellectual delays). A review of Patient 1's "Home Health Certification and Plan of Care," for certification period 2/14/22 to 4/14/22, indicated she was to receive Skilled Nursing (SN- services provided by a licensed nurse including blood sugar monitoring and insulin administration) visits twice daily, seven days a week. A review of Patient 1's "Activity Schedule," for 1/22, indicated Patient 1 had 11 visits that were not scheduled and did not occur. A review of Patient 1's "Activity Schedule," for 2/22, indicated Patient 1 had 7 visits that were not scheduled and did not occur. A review of Patient 1's "Activity Schedule, for 3/1/22 to 3/8/22, indicated Patient 1 had 1 visit that was not scheduled and did not occur. During an interview on 3/8/22 at 4:00 p.m. with the Office Manager (OM), she stated that Patient 1's family sometimes picked her up on Sunday afternoons. Visits were not scheduled for Sundays. The family would then notify the agency if a visit was needed. During a home visit for Patient 1 on 3/9/22 at 3:50 p.m. an interview was conducted with Licensed Nurse (LN) 3. Patient 1 resides in a residential care facility. LN 3 stated she sees Patient 1 two times a day for blood sugar monitoring and insulin (a hormone that regulates blood sugar in the blood) administration. LN 3 stated that Patient 1's family sometimes picks her up on Sunday or Monday afternoon for a few hours. If Patient 1 is with her family, the nurse does not make a visit. The family will monitor the blood sugar and administer insulin. If Patient 1 does not go out with her family or returns early from the family visit, the family or residential care facility will notify LN 3 that a visit is needed. LN 3 charts the visits in the electronic chart. If patient is with the family, no entry is made and it is left blank. LN 3 acknowledged it is not charted as a missed visit and does not indicate why Patient 1 was not seen. A review of Patient 5's "Client Profile" indicated she had a start of care with the HHA on 1/01/15. Her diagnoses included spastic quadriplegia cerebral palsy (difficulty in controlling movements in the arms and legs) and a tracheostomy (an opening surgically created through the neck into the windpipe to allow access to a breathing tube). A review of Patient 5's "Home Health Certification and Plan of Care," for certification period 5/9/21 to end date not included, but signed by RN on 8/13/21 and 3/9/22, indicated orders that included: - SN (skilled nursing) Frequency 56-72 hours/week; - MSW (Masters of Social Worker) Frequency 2 hours/month; and - HH Aide (home health aide) Frequency 283 hours/month A review of Patient 5's "Activity Schedule," for 1/22, indicated Patient 5 had 5 SN visits that were not scheduled and did not occur. A review of Patent 5's "Activity Schedule," for 2/22, indicated Patient 5 had 4 SN visits that were not scheduled and did not occur. A review of Patient 5's "Activity Schedule," for 3/1/22 to 3/8/22, indicated Patient 5 had 1 SN visit that was not scheduled and did not occur. During a telephone interview on 3/10/22 at 10:28 a.m. with the Director of Patient Care Services (DPCS), she stated the "Activity Schedules" color codes nursing visits. A visit marked green indicates it was completed and charting was completed. A visit marked blue, needs review by the DPCS before the charting can be completed, and then will be marked green. A visit marked red indicated a missed visit. During a telephone interview on 3/11/22 at 9:36 a.m. with Patient 5's Family Member (FM), she stated Patient 5 receives nursing services 6 days week, Monday through Saturday. Patient 5 does not have nursing visits on Sunday. The FM stated she wished a nurse would come on Sundays. During a telephone interview on 3/11/22 at 11:27 a.m. with the DPCS, reviewed that Patient 1 did not have visits scheduled for Sunday or Monday afternoons when she was with family and this was not reflected in the orders in the Plan of Care. The DPCS stated that the orders need to reflect this and should be changed. Reviewed with the DPCS that Patient 5 did not have nursing visits scheduled for Sundays and was only receiving 48 hours per week of nursing services. The DPCS stated that orders in the Plan of Care should be changed to match the visit schedule. A review of the agency's policy titled "Care Planning Process," revised 7/19, indicated "...The care planning decisions will be reflected in the specific services that will be provided and the associated actions planned and implemented to meet individualized patient problems and goals..."

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to ensure medication profiles were accurate and medications in the home were current for 2 of 7 sampled patients (Patient 1 and Patient 3) when: 1. Patient 1's medication profile in her clinical record did not match the medication profile in the home, the medication profile failed to include the insulin (a hormone that regulates blood sugar) sliding scale (administration of insulin based on blood sugar levels), one medication was expired, and a mask used in the administration of inhaled medication was past its "discard by" date and; 2. Five (5) medications and 2 topical (used on the skin) creams were not updated on Patient 3's profile. These failures had the potential for Patient 1 and Patient 3 to receive the wrong medications, expired medications or contaminated medications which had the potential to cause adverse effects. 2. During a Home Visit (HV) on 3/9/22 at 11:30 a.m., accompanied by Licensed Nurse (LN 1), Patient 3 was observed sitting up in chair as LN 1 checked his blood sugar using a device and administered the scheduled dose of Humalog insulin (an injectable medication given to manage diabetes). A review of Patient 3's medication Plan of Care (POC) indicated he was admitted by the agency over 4 years ago with a primary diagnoses of diabetes. The POC indicated the Skilled Nurse (SN) was to visit the patient 3 times per day for diabetic management. Patient 3 lived in a board and care home with the owner designated as the primary care giver (CG). A concurrent review of Patient 3's 'Medication Profile' dated 8/21/21 through an open date with LN 1 reflected the following: Trajenta (diabetic pill) 5 milligrams daily (mg, unit of measurement). Patient 3's CG stated the medication was discontinued months ago by the patient's primary physician and she could not recall the date. The CG stated she had communicated that to the visiting LNs. Lantus ( long acting ) insulin 13 units to be given via injection every evening. The nurse stated the insulin dose was increased by the physician to 17 units on 1/13/22 and the CG had filed the order in Patient 3's binder. Metformin (diabetic pill) 1000 mg ONCE daily with meals. The bubble pack which contained the medication from the pharmacy dated 1/21/22 directed the metformin to be taken TWICE daily. Lisinopril 20 mg once daily (a blood pressure pill). The bubble pack that contained the medication indicated 40 mg daily. The CG had a copy of the physician order dated 2/24/22 when the dose of lisinopril was increased and filed in his binder. The profile contained 6 Humalog (short acting) insulin orders that had been discontinued. The LN and Patient 1's CG displayed 2 physician orders for Humalog dated 2/9/21 that directed LNs to increase the breakfast dose to 7 units and continue 5 units for dinner. Another order dated 6/29/21 directed LNs to lower the lunch dose to 3 units. The profile contained two topical creams that the CG stated Patient 3 no longer used and had no supply. LN 1 indicated the medication profile for Patient 3 should have been updated by the LNs who visited the patient 3 times per day. During an interview and concurrent record review on 3/11/22 at 12 p.m., with the Director of Patient Care Services (DPCS), she stated the LNs should be provided access to patients electronic health records to update the medication profile in a timely manner. The DPCS further stated the LNs were expected to check for any medication order changes at the beginning of each week. A review of the agency's policy titled "Medication Profile," revised 10/19, indicated "...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..." Findings: A review of Patient 1's "Client Profile" indicated she had a start of care with the HHA on 7/1/18. Her diagnoses included diabetes mellitus (a disease that causes too much sugar in the blood) and Down syndrome (a genetic disorder that causes developmental and intellectual delays). A review of Patient 1's "Home Health Certification and Plan of Care," for certification period 2/14/22 to 4/14/22, indicated she was to receive Skilled Nursing (SN- services provided by a licensed nurse) visits twice daily, seven days a week. During an interview conducted during a home visit for Patient 1 on 3/9/22 at 3:50 p.m. with Licensed Nurse (LN) 3, LN 3 stated she sees Patient 1 two times a day for blood glucose monitoring (checking the level of sugar in the blood) and insulin administration. In a concurrent observation with LN 3, she compared the medication profile from the clinical record with the medication profile in Patient 1' s home binder and with Patient 1's medications in the home. Patient 1's medication profile in her home binder reflected medication dosages for Divalproex (medication to treat seizures), Risperidone (medication to treat mental disorders), L Thyroxine (a thyroid replacement hormone) had been changed and Mupirocin 2% topical ointment (used to treat skin infections) had been discontinued. The medication profile in the clinical record did not reflect these changes. Patient 1's medication profile in the home binder had handwritten changes indicating dosage changes and discontinuation for these medications. Reviewed with LN 3 that the insulin sliding scale was not on the medication profile. The insulin instructions were written in a signed communication with additional handwritten insulin sliding scale instructions. LN 3 acknowledged that the medication profile in the clinical record did not reflect the medication changes and did not include the sliding scale insulin instructions. Reviewed with LN 3 that Patient 1's Glucagon Emergency Kit (a kit that contains glucagon, a hormone that triggers the liver to release sugar, and is administered to treat very low blood sugar) had expired 3/5/22 and the Aerochamber Plus Flo-Vu Large Mask (a mask used to deliver inhaled respiratory medications) had a "discard by" date of 2/1/22. She confirmed that these items should have been replaced. During a telephone interview on 3/11/22 at 11:27 a.m. with the Director of Patient Care Services (DPCS), reviewed that Patient 1's medication profile in the clinical record did not accurately reflect medication changes and did not contain the insulin sliding scale. The DPCS stated if medication is changed, the medication profile should be updated. She stated the insulin sliding scale should have been included in the medication profile. She stated that currently there is not a process to update the medication profile. She stated, "Nurses need to have access to the medication profile to be able to update at the time of the visit." Reviewed that Patient 1 had a Glucagon Emergency Kit that had expired 3/5/22 and a mask used for inhaled respiratory treatments that had a "discard by" date of 2/1/22 in her home medications. The DPCS stated, "Start of the week, nurse should check for expired medications, discontinued medications, or medications that have been changed." A review of the agency's policy titled "Medication Profile," revised 7/19, indicated "...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..."

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on interview and record review the home health agency (HHA) failed to complete clinical visit notes within 48 hours of the visit per agency policy for 3 of 7 sampled patients (Patient 1, Patient 4, and Patient 5). This failure had the potential to impede the continuity of care for Patient 1, Patient 4, and Patient 5. Findings: A review of Patient 1's Client Profile indicated she had a start of care with the HHA in Summer of 2018. Her diagnoses included diabetes mellitus (a disease that causes too much sugar in the blood) and Down syndrome (a genetic disorder that causes developmental and intellectual delays). A review of Patient 4's "Client Profile" indicated he had a start of care with the HHA in Fall 2018. He had multiple diagnoses including Type 2 diabetes mellitus (too much sugar in the blood) and hypertension (high blood pressure) A review of Patient 5's "Client Profile" indicated she had a start of care with the HHA in Winter of 2015. Her diagnoses included spastic quadriplegia cerebral palsy (difficulty in controlling movements in the arms and legs) and a tracheostomy (an opening surgically created through the neck into the windpipe to allow access to a breathing tube). A review of Patient 1's "Home Health Certification and Plan of Care," for certification period 2/14/22 to 4/14/22, indicated she was to receive Skilled Nursing (SN) visits twice daily, seven days a week. A review of Patient 4's "Home Health Certification and Plan of Care," for period 3/26/21 to 5/24/21 and 5/23/21 to 8/22/21, indicated orders for SN (skilled nursing) were twice daily. The Plan of Care for the period 2/19/22 to 4/19/22 did not contain any orders for disciplines and treatments. A review of Patient 5's "Home Health Certification and Plan of Care" for certification period 5/9/21 to no end date included, but signed by RN on 8/13/21 and 3/9/22, orders for SN (skilled nursing) services with a frequency 56-72 hours/week. A review of Patient 1's "Activity Schedule," for 1/1/22 to 3/8/22, indicated 6 nursing visit notes had not been reviewed and completed by the Director of Patient Care Services (DPCS). A review of Patient 4's "Activity Schedule," for 1/2/22 to 3/8/22, indicated that 28 nursing visit notes had not been reviewed and completed by the DPCS. A review of Patient 5's "Activity Schedule," for 1/1/22 to 3/8/22, indicated that 35 nursing visit notes had not been reviewed and completed by the DPCS. During an interview on 3/9/22 at 3:50 p.m. with LN 3, she stated she completes her visit notes the same day as the visit. She enters the notes into a charting application using her phone. LN 3 stated the she has 24 hours to have her nursing visit notes done. During a telephone interview on 3/10/22 at 10:28 a.m. with the DPCS, she stated the expectation is that charting will be done at the time of the visit or within 24 to 72 hours. She stated that the policy states it will be done within 24 hours. The DPCS reviews the visit charting and nursing documentation. She stated past visits that are color coded blue in patient's "Activity Schedule" means that the visit did not occur, the nurse did not document, or the DPCS needs to review the note. She does the second validation and then completes the visit note. When the the DPCS completes the review, the visit in the patients' "Activity Schedule" turns green meaning the visit was completed and documentation was completed. Reviewed that Patient 1, Patient 4, and Patient 5 had multiple visits coded blue for January 2022, February 2022, and March 2022. She stated she will complete "as soon as I can." A review of the agency's policy titled "Documentation Requirements," updated 9/8/20, indicated "...Document in a timely manner, within 48 hours of your visit..." A review of the agency's policy titled "Entries Into The Clinical Record," revised 7/19, indicated "...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...Entries into the clinical record will be made on the day care is provided to the patient.." A review of the agency's policy titled "Clinical Record Review," revised 7/19, indicated "...Clinical records will be reviewed at frequent intervals by the Director of Patient Care Services or designee to ensure that documentation is entered and is reliable, timely, valid, and accurate..."

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on observation, interview and clinical record and facility policy and procedure review, it was determined that the Home Health Agency (HHA) Governing Body failed to designate a person to act in the absence of the administrator and oversee the overall daily operations of the agency (G954), ensure the Director of Patient Care Services (DPCS) was available for sufficient hours to oversee, supervise and train the nursing staff (G950) and coordinate patient care (G962). The agency failed to ensure patient's needs were continually assessed (G966) and failed to update the Plan of Care every 60 days G968). The cumulative effect of these systemic practices had the potential to decrease the agency's ability to meet the patients' needs and provide oversight to the clinical staff.

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the agency failed to ensure the Director of Patient Care Services (DPCS) was available to oversee, supervise and train the nursing staff when she worked 15 hours per week for a census of 18 patients. This failure had the potential to negatively impact patient care and services. Findings: During the Entrance Conference on 3/8/22 at 8:55 a.m., two non-clinical staff were in the office and they reported the Office Manager (OM) will be coming in. The OM arrived at 9:56 a.m. and stated the Administrator was based in another state and was at the agency on 3/7/22. The OM stated the DPCS was hired mid last year and worked from home for 15 hours a week. The OM stated the DPCS came to the office once since she was hired. On 3/9/22 at 1:30 p.m., the OM was asked if the DPCS was coming to the office the next day on 3/10/22 for an interview with the Department. The OM stated she would let her know. Shortly after 1:30 pm., the OM reported the DPCS was available via video conference at 1 p.m. but was not able to come to the agency. In a telephone interview conducted on 3/10/22 at 10:28 a.m., with the DPCS, she stated she was hired in early June 2021 for 15 hours per week. The DPCS stated she lived 2 hours from the agency and has been to the office once to pick up supplies. The DPCS stated she had not completed the skill checks or annual evaluations for the nursing staff working under her supervision. The DPCS stated that she had not completed any in-service training for the nursing staff except one on tube feeding. The DPCS stated she was not involved in the hiring process for the nursing staff. The DPCS reported she was not able to access medical records that were more than 2 years old and was not sure why they were not retrievable. When the DPCS was asked about the nursing documentation that was not marked as completed for some of the sampled patients the Department was reviewing or why missed visits were not reported to the physician, the DPCS stated she was behind with her nursing documentation audits. When the DPCS was asked if 15 hours were adequate to supervise the clinical services for 18 active patients, she stated she was only allotted 15 hours on hire but she needed more hours to catch up with the clinical record audits, in-service training, competency testing and performance evaluation for staff. A review of the job description for the 'Director of Patient Care Services -DPCS' signed and dated by the DPCS on 6/15/21 indicated she was overall in-charge of clinical services and was responsible for agency compliance with regulations, managing clinical staff, conducting infection control in-services, conducting clinical interviews for nursing hires, overseeing patient's assessments and plan of care, coordinating the care provided to patients, overseeing timely and accurate documentation of the medical records among other responsibilities. The job description indicated the DPCS reported to the Administrator. During an interview on 3/10/22 at 3:28 p.m., the Administrator stated that he had made the determination that 15 hours per week was adequate for the DPCS position. The Administrator stated the 18 patients the agency was currently providing care for were all Medi-Cal and he was keeping the agency open to help people. The Administrator stated he comes to the agency once a week and he had no Administrator designee. The onsite survey was conducted 3/8/22 through 3/11/22 and neither the Administrator nor the DPCS came to the office.

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 document review, the agency Administrator failed to designate a person to act in his absence as per their policy for a census of 18 patients. This failure had the potential to negatively impact the day to day operations of the agency. Findings: During the Entrance Conference on 3/8/22 at 8:55 a.m., two non-clinical staff were in the office and they reported the Office Manager (OM) will be coming in. The OM arrived at 9:56 a.m. and stated the Administrator was based in another state and was last at the agency on 3/7/22. A review of the agency's undated 'Organization Chart' document reflected no administrator designee. A review of the agency's policy titled 'Designation of Individual in Absence of Administrator' revised 7/2019 indicated in part, " [Agency's name] will have an Executive Director/ Administrator or designee available at all times. In the event that the Executive Director/Administrator is absent, the Director of Patient Care Services [DPCS] will assume the operational duties and responsibilities at [name of agency]. In the event both Executives are absent , an appropriately qualified nurse will assume the responsibilities." A former DPCS was listed as the Administrator designee on the policy. During an interview on 3/10/22 at 10;28 a.m., with the DPCS, she stated she was not the administrator designee. During a telephone interview on 3/10/22, at 3:28 p.m., the Administrator stated he comes to the agency once a week. The Administrator stated he had not appointed an Administrator designee for about 3 months. The Administrator further stated he was usually available within one or two hours. When asked why there was no current designee, he stated "Don't need one."

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure care was coordinated as per policy for 7 of 7 sampled patients (Patient 1, 2, 3, 4, 5, 6, and 7) when there was no documented evidence in the patients' clinical record it occurred. This failure had the potential to result in delay in the implementation of the plan of care. Findings: During a review of 7 of 7 sampled patients' clinical records, there was no documentation that care was coordinated among the nursing staff, the clinical manager (DPCS), the patients and/or their care-givers. An interview conducted on 3/11/22, at 11:27 a.m., with the Director of Patient Care Services (DPCS), she stated the agency was currently providing care for 18 patients. The DPCS stated she talked to the families during visits and the individual nurse assigned to the patient if she needed to clarify an issue. The DPCS stated she had not completed any care conference or coordinated care with the nursing staff, the patients and/or their care-givers since she was hired. The DPCS stated, '...that’s something we need to start doing...’ A review of the agency's policy titled, 'Care Coordination' revised 7/2019 indicated in part, "Written evidence of care coordination will be recorded during the case conference and repeated in skilled nursing visit reports in the patient's clinical records ... A registered nurse will be assigned to patients receiving skilled nursing ... Care coordination will include ... Planned face-to-face conferences ... Timely documentation of coordination of care activities ... Appropriate involvement of the patient and caregivers ..."

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to complete comprehensive assessments within the last five days of every 60 days for 2 of 7 sampled Patients (Patient 4 and Patient 5). This failure had the potential that care needs would not be identified for Patient 4 and Patient 5. Findings: A review of Patient 4's "Client Profile" indicated he had a start of care date with the HHA on 10/4/18. His diagnoses included diabetes mellitus (too much sugar in the blood) and hypertension (high blood pressure). A review of Patient 5's "Client Profile" indicated she had a start of care date with the HHA on 1/10/15. Her diagnoses included spastic quadriplegia cerebral palsy (difficulty in controlling movements in the arms and legs) and a tracheostomy (an opening surgically created through the neck into the windpipe to allow access to a breathing tube). A review of Patient 4's clinical record indicated he had comprehensive assessments completed for recertification for home health services on 3/24/21, 5/26/21, and 7/2/21. A comprehensive assessment for recertification was initiated on 1/24/22, but not completed. It was electronically signed by the Director of Patient Care Services (DPCS) on 1/24/22. A review of Patient 5's clinical record indicated she had comprehensive assessments completed for recertification for home health services on 3/4/21, 4/21/21, and 9/13/21. A comprehensive assessment, dated 12/29/21, was not completed. During an interview on 3/9/22 at 12:36 p.m. with the Office Manager (OM), reviewed that Patient 5's comprehensive assessment in the clinical record, dated 12/29/21, was not completed. The OM stated the nurse who initiated the recertification assessment on 12/29/21 is out of the country. She stated he may have completed it on paper and it may be in the patient's home. She stated she does not have a way to contact the nurse to verify if it was done. The OM acknowledged that the comprehensive assessment for recertification for Patient 4, initiated on 1/24/22, was not completed, but was signed by the DPCS on 1/24/22. The OM stated she did not know why this occurred. During an interview on 3/10/22 at 10:28 a.m. with the DPCS, she stated she does the recertification assessments for patients. Recertification assessments are done every sixty days. She completes the recertification assessments within one week before the sixty days is reached. The DPCS acknowledged that the recertification assessment for Patient 4, dated 1/24/22, was not complete, but that she did electronically sign it. She stated it should have been completed so that the care plan would be personalized and updated. A review of the agency's policy titled "Ongoing Assessments," revised 7/19, indicated "...The scope and intensity of ongoing assessments will be determined by the patient's diagnoses, condition, desire for care, response to previous care, and the care setting...Based on the findings of the reassessment, additional orders will be generated and forwarded to the physician for signature(s)..."

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to update the Plan of Care every 60 days for three of seven sampled Patients (Patient 4, Patient 5, Patient 6). This failure had the potential for the patients care needs to be unmet. Findings: A review of Patient 4's "Client Profile" indicated he had a start of care with the HHA on 10/4/18. He had multiple diagnoses including diabetes mellitus (too much sugar in the blood) and hypertension (high blood pressure) A review of Patient 5's "Client Profile" indicated she had a start of care with the HHA on 1/10/15. Her diagnoses included spastic quadriplegia cerebral palsy (difficulty in controlling movements in the arms and legs) and a tracheostomy (an opening surgically created through the neck into the windpipe to allow access to a breathing tube). A review of Patient 6's "Client Profile" indicated he had a start of care with the HHA on 5/22/19. He had multiple diagnoses including diabetes mellitus and hypertension. A review of Patient 4's "Home Health Certification and Plan of Care," indicated certification periods for 3/26/21 to 5/24/21,5/23/21 to 8/22/21, and 2/19/22 to 4/19/22. The Plan of Care for periods 3/26/21 to 5/24/21 and 5/23/21 to 8/22/21, indicated orders for SN (skilled nursing) were twice daily. The Plan of Care for the period 2/19/22 to 4/19/22, did not contain any orders for disciplines and treatments. The clinical record did not contain a Plan of Care for the period from 5/24/21 to 2/19/21. A review of Patient 5's "Home Health Certification and Plan of Care" for certification periods 11/10/20 to 3/9/21, 3/10/21 to 5/8/21, and 5/9/21 to no end date included, but signed by RN on 8/13/21 and 3/9/22, indicated orders: - SN (skilled nursing) Frequency 56-72 hours/week; - MSW (Masters of Social Work) Frequency 2 hours/ month; and - HH Aide (home health aide) Frequency 283 hours/ month The certification period 11/10/20 to 3/9/21 was greater than 60 days. The Plan of Care certification period 5/9/21 did not include an end date, but had been signed on 8/13/21 and then again on 3/9/22 by the RN indicating a certification period greater than 60 days. A closed record review of Patient 6's "Home Health Certification and Plan of Care" for certification periods 8/28/20 to 11/25/20 and 11/26/20 to 3/10/21 indicated orders that included SN 4 times a day. The certification periods were greater than 60 days. During an interview on 3/9/22 at 12:36 p.m. with the Office Manager (OM), acknowledged that the certification period date of 5/9/21 for Patient 5's "Home Health Certification and Plan of Care" was incorrect. There is not a current care plan with orders because the comprehensive assessment had been initiated on 12/29/21, but not completed. The assessment would have been a trigger for the Plan of Care to be completed. During an interview on 3/9/22 at 2:08 p.m. with the OM, she acknowledged that the certification periods for Patient 6's Plan of Care were greater than 60 days. She stated that she did not know why this occurred and that it happened before she started working at the agency. During a telephone interview on 3/10/22 at 10:28 a.m. and a subsequent telephone interview on 3/11/22 at 11:27 a.m. with the Director of Patient Care Services (DPCS), she stated the "Home Health Certification and Plan of Care" is completed every 60 days or as needed for a change in condition. The DPCS stated she does the comprehensive assessments for recertification every 60 days. She stated that the Plan of Care is not able to be completed if the assessment was not done. The DPCS acknowledged that Patient 4, Patient 5, and Patient 6's care plans were not updated every 60 days. Patient 4's Plan of Care for 2/19/22 to 4/19/22 did not contain orders for disciplines and treatments. She stated she has found many inconsistencies when auditing the clinical records. A review of the agency's policy titled "Care Planning Process," revised 7/19, indicated "... The plan of treatment will be revised as frequently as deemed necessary by the clinician, based on the ongoing assessments of the patient. Revision dates will be noted on the plan of treatment...The plan of treatment will be reviewed and updated by the attending personnel at least every 62 days..."

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 to include in the clinical record complete clinical visit notes for 3 of 7 sampled patients (Patient 1, Patient 4, and Patient 5). This failure had the potential to impede the continuity of care for Patient 1, Patient 4, and Patient 5. Findings: A review of Patient 1's Client Profile indicated she had a start of care with the HHA on 7/1/18. Her diagnoses included diabetes mellitus (a disease that causes too much sugar in the blood) and Down syndrome (a genetic disorder that causes developmental and intellectual delays). A review of Patient 4's "Client Profile" indicated he had a start of care with the HHA on 10/4/18. He had multiple diagnoses including Type 2 diabetes mellitus (too much sugar in the blood) and hypertension (high blood pressure) A review of Patient 5's "Client Profile" indicated she had a start of care with the HHA on 1/10/15. Her diagnoses included spastic quadriplegia cerebral palsy (difficulty in controlling movements in the arms and legs) and a tracheostomy (an opening surgically created through the neck into the windpipe to allow access to a breathing tube). A review of Patient 1's "Home Health Certification and Plan of Care," for certification period 2/14/22 to 4/14/22, indicated she was to receive Skilled Nursing (SN) visits twice daily, seven days a week. A review of Patient 4's "Home Health Certification and Plan of Care," for certification period 3/26/21 to 5/24/21 and 5/23/21 to 8/22/21, indicated he was to receive SN visits twice daily. The Plan of Care for the period 2/19/22 to 4/19/22 did not contain any orders for disciplines and treatments. A review of Patient 5's "Home Health Certification and Plan of Care" for certification period 5/9/21 to no end date included, but signed by the RN (Registered Nurse) on 8/13/21 and 3/9/22, indicated she was to receive SN services with a frequency 56-72 hours/week. A review of Patient 1's "Activity Schedule," for 1/1/22 to 3/8/22, indicated 6 nursing visit notes had not been reviewed and completed by the Director of Patient Care Services (DPCS). A review of Patient 4's "Activity Schedule," for 1/2/22 to 3/8/22, indicated that 28 nursing visit notes had not been reviewed and completed by the DPCS. A review of Patient 5's "Activity Schedule," for 1/1/22 to 3/8/22, indicated that 35 nursing visit notes had not been reviewed and completed by the DPCS. During an interview on 3/9/22 at 3:50 p.m. with Licensed Nurse (LN) 3, she stated she completes her visit notes the same day as the visit. She enters the notes into a charting application using her phone. LN 3 stated the she has 24 hours to have her nursing visit notes completed. During a telephone interview on 3/10/22 at 10:28 a.m. with the DPCS, she stated she reviews visit charting, does recertifications, and initial and comprehensive assessments. She works mainly remotely and is scheduled for 15 hours per week. She stated she relies heavily on chart review, but communicates with staff by phone or email. The DPCS stated she audited charts and has found many inconsistencies. The DPCS stated the expectation is that charting will be done at the time of the visit or within 24 to 72 hours. She stated that the policy states it will be done within 24 hours. She stated past visits that are color coded blue in patient's "Activity Schedule," means that the visit did not occur, the nurse did not document, or the DPCS needs to review the note. She does the second validation by reviewing the nurse's note and then completes the visit note. When the DPCS completes the visit note, the visit in the patient's "Activity Schedule" turns green meaning the visit was completed and documentation was completed. Reviewed that Patient 1, Patient 4, and Patient 5 have multiple visits coded blue for January 2022, February 2022 and March 2022. The DPCS acknowledged that she "gets behind on charting." She stated she will complete "as soon as I can." A review of the agency's policy titled "Contents Of The Clinical Record," revised 7/19, indicated "...A clinical record will be maintained for each patient receiving care. The clinical record will contain sufficient information to identify the patient, describe the patient's problems and needs, justify care, accurately document care provided and results in detail, and facilitate continuity of care among organization and contract personnel...Clinical notes will be signed and incorporated into the patient's health record at least every seven days..." A review of the agency's policy titled "Entries Into The Clinical Record," revised 7/19, indicated "...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...Entries into the clinical record will be made on the day care is provided to the patient.." A review of the agency's policy titled "Clinical Record Review," revised 7/19, indicated "...Clinical records will be reviewed at frequent intervals by the Director of Patient Care Services or designee to ensure that documentation is entered and is reliable, timely, valid, and accurate..."

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 home health agency (HHA) failed to ensure a discharge assessment and discharge summary was completed and retained in the clinical record for 2 of 7 sampled patients (Patient 6 and Patient 7). This failure had the potential to negatively impact the continuity of care for Patient 7 and Patient 6's clinical record was incomplete. A review of Patient 7's Plan of care (POC) dated 1/30/21 through 4/1/21 indicated he was admitted in spring of 2020 with a diagnosis of cerebral palsy (congenital disorder of movement, muscle tone or posture) and needed assistance with feeding via a stomach tube, medication administration, monitoring of his health condition and ensuring safety was maintained. The Skilled Nurse (SN) was to visit 8 hours a day for 5 days during no school and 40 hours a week during school. A further review of Patient 7's record reflected an assessment completed on 4/16/21. An interview conducted with the Office Manager (OM) on 3/9/22 at 3 p.m., to establish if Patient 7 was currently being seen by the agency, the OM stated the patient was discharged on 4/1/21 when the nurse who was assigned to the patient was no longer available. The OM stated the family was offered a replacement but they declined. The OM stated she communicated to the former Director of Nursing Services (DPCS) about the challenges of getting a nurse for the patient and provided an email conversation dated 5/3/21 from Patient 7's case manager seeking to establish if the agency was still providing care for the patient. The OM had indicated the patient was discharged on 4/1/21. The OM stated she was not sure why an assessment was completed on 4/16/21 if the Patient had been discharged on 4/1/21. The OM stated the former DPCS had resigned on 4/8/21 and she did not complete the discharge assessment. During an interview and concurrent record review with the current DPCS on 3/11/22 at 11:27 a.m., she stated she was not able to determine where Patient 7 went from reviewing the record because it was not documented. The DPCS stated if Patient 7 was discharged, the clinical record should contain a discharge assessment, a discharge summary and a physician order to discharge or transfer the patient. A review of the home health agency's policy titled "Discharge Summary," revised 7/19, indicated "...Each patient discharged from a service and from the organization will have a written discharge summary filed in the clinical record... The discharge summary and other relevant clinical record documents will be completed and submitted in the medical record..." Findings: A review of Patient 6's "Client Profile" indicated Patient 6 had a start of care on 5/22/19. He had multiple diagnoses including diabetes mellitus (too much sugar in the blood) and hypertension (high blood pressure). A review of Patient 6's clinical record, reflected a "Home Health Certification and Plan of Care," with certification period 11/26/20 to 3/10/21, that indicated he had orders for Skilled Nurse (SN) services four times a day. A review of a "Physician Order," dated 3/10/21, for Patient 6 indicated "Patient dc [discharge] from HH [Home Health] services due to death caused by complications of seizures 3/9/2021. Care team notified." A record review of "Non-oasis discharge" (an assessment tool), dated 3/10/21, for Patient 6 indicated "...Patient was admitted to the hospital on 3/8/2021 d/t [due to] the home care staff found the patient unconscious. Patient was admitted to the hospital for strokes. Patient is dc from HH services due to unforeseen death d/t complication of stroke. Agency notified on 3/10/2021. Care team informed..." A discharge summary for Patient 6 was not found in his clinical record. During a telephone interview on 3/10/22 at 10:28 a.m. and a subsequent telephone interview on 3/11/22 at 11:27 a.m. with the Director of Patient Care Services (DPCS), she acknowledged that there was not a discharge summary in Patient 6's clinical record. She stated, "Should have discharge summary, don't see one in the chart." She stated the discharge summary should be completed the same day as the discharge or within 24 hours of discharge. A review of the home health agency's policy titled "Discharge Summary," revised 7/19, indicated "...Each patient discharged from a service and from the organization will have a written discharge summary filed in the clinical record... The discharge summary and other relevant clinical record documents will be completed and submitted in the medical record..."

Retrieval of records CFR(s): 484.110(e) Standard: Retrieval of clinical records. A patient's clinical record (whether hard copy or electronic form) must be made available to a patient, free of charge, upon request at the next home visit, or within 4 business days (whichever comes first). This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure records were readily retrievable for 18 active patients and for discharged patients. This failure had the risk potential to negatively impact the continuity of care for the 18 active patients. Additionally, records for discharged patients were not available prior to 2020. Findings: During an interview on 3/9/22 at 1:35 p.m., with the Office Manager (OM), she was asked why the Department was unable to access older electronic or paper records for a discharged patient. The OM stated the agency started using the new electronic system from a new server about 2 years ago. The OM further stated her understanding was that the old records were saved on a flash drive and only the Administrator and the accounting staff had access to it. The OM stated if the office needed a certain record, they would have to request it from the accounting department located in another State. The OM stated all the paper records were scanned to the former electronic system and the paper records to her knowledge were destroyed. An interview conducted with the Director of Patient Care Services (DPCS) on 3/10/22 at 10:28 a.m., when she was asked to retrieve the clinical record for an active patient admitted over 4 years ago, she stated she was only able to access his records for 2 years. The DPCS was not sure why she could not access his older clinical record. In an interview conducted with the Administrator and the OM on 3/10/22 at 3:28 p.m., he stated the old records for the active and discharged patients could only be retrieved from the old server and he would have to contact the IT for that server. The Administrator stated those records were not easily accessible. The Administrator further stated, the paper records had been destroyed. A review of the agency's policy titled, 'Safeguarding/Retrieval of Clinical Records' dated 7/2019 indicated in part, "The organization will safeguard the clinical record against loss, destruction ... Security of information will be ensured for electronic and manual systems, and will include such issues as: A backup system plan, either computerized or manual ... Data retrieval processes ... Other arrangements have been made for the safe preservation of patient's health records, and that health records are available ... Policies and procedures which address the retention, retrieval, and security ... of inactive patients records." Review of another agency's policy titled, 'Access to Information' dated 7/2019, indicated, "Each patient health records will be readily available for review upon request of the attending physician or other prescriber, any authorized employee, agent or officer of the agency, authorized representative of the Licensing Department or any other person authorized by law to make such a request ... The organization will maintain backup patient and financial data at a safe off-site location for use in the event a disaster prevents access to files in the office period."