Every finding on record at Tarlani Corp.

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) to assess the patient’s continuing need for home care services for one of 11 sampled patients (Patient 26). This failure had the potential not to meet Patient 26’s needs. Findings: During a review of Patient 26’s Patient Information sheet indicated a start of care date of 6/7/2024. During a review of Patient 26’s Home Health Certification and Plan of Care for the certification period from 6/7/2024 to 8/5/2024, the Home Health Certification and Plan of Care indicated Patient 26’s diagnosis included hypertension (high blood pressure). The Home Health Certification and Plan of Care indicated an order for the skilled nurse (SN) to visit Patient 26 once a week for one week, then twice a week for three weeks, and then once a week for five weeks for the implementation of the prescribed plan of care, comprehensive skilled nursing assessment, and observation and evaluation of all body systems. The Home Health Certification and Plan of Care indicated the goal included Patient 26’s blood pressure would remain stable and within normal parameters. The Home Health Certification and Plan of Care indicated to discharge Patient 26 when goals were met. During a review of Patient 26’s Home Health Certification and POC, the Home Health Certification and POC indicated Patient 26 was recertified for another 60 days for continuous skilled nursing services, from 8/6/2024 to 10/4/2024. During a telephone interview, on 8/21/2024, at 3:49 p.m., with Licensed Vocational Nurse 3 (LVN 3), LVN 3 stated she visited Patient 26 six times for the month of June 2024 from 6/10/2024 to 6/28/2024, and three times for the month of July 2024 from 7/11/2024 to 7/26/2024. LVN 3 stated not to rely anymore on the contents of her visit notes and assessment of Patient 26 on her visits for the month of June 2024 and July 2024 because all her visit notes were altered by the agency’s Director of Patient Care Services (DPCS) to make Patient 26’s condition worse than what she observed and assessed during her visits. LVN 3 stated Patient 26 was not homebound, was independent of all his care, never complained of any pain during all her visits, did not have wounds, no falls, would take his medications regularly, and would drive. During a review of Registered Nurse 1 (RN 1) Declaration dated 8/21/2024, indicated Patient 26 did not need help with feeding, medication, and toileting. RN1’s Declaration indicated the DPCS “fraudulently exaggerated,” Patient 26’s condition in Patient 26’s clinical record under her name and credentials (RN 1). During a telephone interview on 8/22/2024, at 8:56 a.m., with Patient 26, Patient 26 stated he was independent of all his care, took his medications daily, never had a caregiver, still drove, walked half a mile every day, did not have any wounds, no falls, no hospitalization since he was admitted to the HHA, and denied any pain. During an interview, on 8/23/2024, at 11:05 a.m., with the DPCS, the DPCS stated Patient 26 was recertified for another 60 days for continuous skilled nursing services because he was homebound, reported pain, had unstable gait (walk), hired a new caregiver for home assistance, and had dizziness. The DPCS stated Patient 26 did not have recent hospitalization, no falls, no wound care, and was not undergoing rehabilitation therapy. During a review of the agency’s policy and procedure (P&P) titled, “Admission Criteria and Process,” revised January 2012, the P&P indicated the agency will accept any patient who was appropriate for home health, regardless of payment source. During a review of the agency’s P&P titled, "Discharge Criteria and Process," revised January 2012, the P&P indicated the purpose of the policy is to outline the process for discharging a patient from service. The P&P indicated the services will be terminated when the patient meets one of the following discharge criteria…. if appropriate, the goal of home health have been attained or are no longer attainable.

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 observation, interview, and record review, the home health agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure the plan of care (POC) covered all pertinent diagnoses for one of 11 sampled patients (Patient 18). For Patient 18, there was no care outlined in the POC for hemodialysis (procedure that performs the functions of the kidneys in people whose kidneys failed) management that included assessing arteriovenous access site (AV fistula, connection of a vein and an artery through a surgical procedure, used during hemodialysis). This deficient practice has the potential for the delay when responding to an emergency situation that could lead to complications like bleeding, infection and clotted or nonfunctioning arteriovenous access site. Findings: During a review of Patient 18’s "Patient Information" (undated) sheet, the "Patient Information" indicated a start of care date of 7/4/2023. During a review of Patient 18’s "Home Health Certification and Plan of Care (POC)" form for the certification period from 6/28/2024 to 8/26/2024, the "Home Health Certification and Plan of Care (POC) indicated patient’s diagnoses included sepsis (a life-threatening complication of an infection) and osteomyelitis (inflammation or swelling that occurs in the bone). The POC included an order for the skilled nurse (SN) to visit Patient 18 three times a week for eight weeks for assessment and evaluation of all body systems, pain assessment, assess and perform wound care treatment on left foot ulcer (open wound or sore that will not heal or keeps returning), and to assess and instruct patient and patient caregiver compliance and knowledge of medications. The goal included patient’s wound will heal without signs and symptom of infection, will be free from pain, patient/patient caregiver will verbalize and demonstrate knowledge of and compliance with medication management, and patient will have no hospitalization throughout the plan of care. However, the POC did not include instructions on hemodialysis care/management, including AV fistula site monitoring for bleeding/infection, bruit (audible vascular sound associated with turbulent blood flow usually heard with the stethoscope), thrill (vibration accompanying a vascular murmur that can be palpated), and instruction regarding emergency bleeding situation. During a home visit, on 8/21/2024 at 9:30 a.m., with a licensed vocational nurse (LVN 1), Patient 18 was observed sitting in a sofa, alert and oriented x 3 (to person, place, and time), and was able to communicate. Patient 18 was observed with an AV fistula on his left upper arm. During an interview, on 8/21/2024 at 9:55 a.m., with Patient 18, Patient 18 stated he has dialysis treatment three times a week and had the AV fistula on his left upper arm for 10 years. During an interview, on 8/23/2024 at 10:50 a.m., with the Director of Patient Care Services (DPCS), the DPCS stated the POC should have included all the care/services the patient needed including care and management of Patient 18’s AV fistula. During a review of the agency’s policy and procedure (P&P) titled, “Care Planning Process,” revised January 2012, the P&P indicated a written plan of care will be initiated within seven days of start of care and updated at least every 60 days, or as patient’s condition warrants. The clinical plan of care includes pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, orders and frequency for the patient/caregiver to perform glucose monitoring, treatments, safety measures, instructions, discharge plan.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) staff failed to check blood sugar level as ordered by the physician for one of 11 sampled patients (Patient 27). This deficient practice resulted for the patient not receiving the quality of care and services identified in the plan of care (POC). During a review of Patient 27’s "Patient Information" sheet (undated), the "Patient Information" indicated a start of care (SOC) on 8/2/2023, with diagnoses including type 2 diabetes mellitus (a medical condition characterized by the body's inability to regulate blood sugar levels). During a review of Patient 27's "Home Health Certification and Plan of Care" for the certification period starting from 7/27/2024 to 9/24/2024, the "Home Health Certification and Plan of Care" included an order for the skilled nurse (SN) frequency of visit one visit every one week for a week starting week one, three visits, every one week for eight weeks starting week two. The "Home Health Certification and Plan of Care" in the "Endocrine/ Diabetes Management" section Indicated: SN to check patient’s blood sugar every visit. During a review of Patient 27's "SN Visit Note with Wound Care", the "SN Visit Note with Wound Care" indicated Patient 27’s blood sugar was not checked and monitored during SN visits dated 8/13/2024, 8/15/2024, and 8/17/2024. During an interview and concurrent record review on 8/23/2024, at 11:50 a.m. with the Director of Patient Care Services (DPCS), the DPCS stated plan of care is doctors order that home health nurse should follow. The DPCS confirmed there was no documented evidence that nurses checked Patient 27's blood sugar during their home visits dated 8/13/2024, 8/15/2024, and 8/17/2023 and/or Patient 27 refused blood sugar check. During a review of the agency’s policy and procedure (P&P) titled, “Care Planning Process”, revised January 2012, the P&P indicated a written plan of care will be initiated within seven days of start of care and updated at least every 60 days, or as patient’s condition warrants...5. The plan of care 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.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure contents and information in the patients' medical records were safeguarded from unauthorized access by unauthorized HHA staff to make any alterations or modifications for two of 11 sampled patients (Patient 26 and Patient 28). This deficient practice has the potential to result in an unauthorized and inaccurate patient information and assessment that would be entered in the patients' medical records that could affect the patient's quality of care and well-being. Findings: a. During a review of Patient 26’s Patient Information sheet, the Patient Information sheet indicated Patient 26's start of care date was 6/7/2024. During a review of Patient 26’s Home Health Certification and Plan of Care (POC, a document that lists the services and items needed for a patient to receive home health care, as well as the frequency of those services and the expected treatment outcomes) form for the certification period from 6/7/2024 to 8/5/2024, indicated patient’s diagnoses which includes encounter for surgical aftercare following surgery on the circulatory system (a network of organs that circulates blood throughout the body, delivering oxygen and nutrients to cells and removing waste), atherosclerotic heart disease (a build-up of cholesterol plaque in the walls of arteries causing obstruction of blood flow) of native coronary artery without angina pectoris (a type of chest pain caused by reduced blood flow to the heart), and essential hypertension (high blood pressure). The POC included an order for the skilled nurse (SN) to visit the patient once a week for 1 week, then twice a week for 3 weeks, and then once a week for 5 weeks for the implementation of the prescribed plan of care, comprehensive skilled nursing assessment, and observation and evaluation of all body systems. During a review of Patient 26’s OASIS E (or Outcome and Assessment Information Set, a group of standard data elements home health agencies integrate into their comprehensive assessment, to collect and report quality data to the Centers for Medicare & Medicaid Services) Start of Care Assessment, dated 6/7/2024 and signed by the registered nurse (RN 1), the OASIS assessment indicated Patient 26 was confused, anxious all of the time, unable to care for self, depends on spouse for assistance with all ADLs (activities of daily living, are activities related to personal care which includes bathing, grooming, dressing, toileting, and eating), increased episodes of anxiety out of control, used walker at all times, non-weight bearing (NWB) status to LLE (left lower extremity [left leg]) and LUE (left upper extremity [left arm]), unable to leave home at present time due to NWB restrictions and chronic pain to right foot/ankle. The assessment further indicated under section G-Functional Status, Patient 26 was dependent entirely upon someone on all his care. During a review of Patient 26’s OASIS E Recertification Assessment, dated 8/1/2024 and signed by the RN 1, the recertification assessment indicated Patient 26 was confused and anxious at times, unable to care for self, depends on spouse for assistance with all ADLs, increased episodes of anxiety out of control, has cognitive (relating to the mental processes of perception, memory, judgment, and reasoning) deficits and balance trouble, used walker at all times, NWB status to LLE and LUE, pain to right foot and right ankle, and was unable to leave home at present time due to NWB restrictions, The assessment further indicated under section G-Functional Status, Patient 26 was dependent entirely upon someone on all his care. During a review of the Department Licensing and Certification Division Declaration form, executed and signed by the registered nurse (RN 1) on 8/21/2024, RN 1 stated, “(Patient 26) has been seen twice by myself, once in June for SOC (start of care) and in August for Recert (or Recertification, a process that occurs when a physician or other practitioner certifies that a patient still needs home health care after an initial 60-day certification period)…I checked my visits on 8/1/24 and June 6th SOC. It was discovered that (Director of Patient Care Services/DPCS) went into the notes and altered them. The notes were forged with false information as to the patients condition. My original note for SOC/Recert had (Patient 26) as supervised under functional status, supervised in eating, no functional deficits, no anxiety, no depression, cognitively intact. The notes now state – dependent in all care, incontinent (unable to voluntarily control retention of urine or feces in the body), chairfast, BIMS (or Brief Interview for Mental Status) of 11 (patients with a BIMS score of 8–12 were considered to be “mildly impaired”), daily constant anxiety, needing help recalling month, needing cueing to remember “sock” for cognition, needing full care. Then my name and credentials are signed. I did not chart this, this is not the functionality of the patient. The patient condition was fraudulently exaggerated by (DPCS), and the LVN (licensed vocational nurse) visits on 8/9 & 8/16 did not happen. Also the supervisory visit on 7/11/24 was not completed by myself”. During a phone interview, on 8/22/2024 at 8:56 a.m., with Patient 26, he stated he was not visited by LVN 3 or any nurses from the HHA on 8/9/2024 and 8/16/2024. Patient 26 stated the last time he was visited by the HHA’s SN was on 8/1/2024. Patient 26 stated he was independent of all his care, takes his medications daily, never had a caregiver, still drives, walks half a mile every day, have no wounds, no falls, no hospitalization since he was admitted to the HHA, and denies any pain. During a record review of Patient 26’s electronic health record (EHR), on 8/22/2024, there was a SN visit note that indicated Patient 26 was visited on 8/9/2024 from 9 a.m. to 10 a.m., and on 8/16/2024 from 1 p.m. to 1:45 p.m. The EHR indicated that it appears LVN 3 visited, signed, and submitted the visit note on 8/9/2024 and 8/16/2024. However, during a review of the EHR Document History, it indicated the SN visit note dated 8/9/2024 were accessed by one of the agency’s staff (PM 1) twice, on 8/20/2024 at 8:54 p.m. and at 9:12 p.m. and by the DPCS two times on 8/20/2024 at 9:18 p.m. and 9:20 p.m. but not by LVN 3. The EHR Document History further indicated the SN visit note dated 8/16/2024, were accessed by PM 1 on 8/20/2024 at 8:43 p.m. and by the DPCS four times on 8/20/2024 at 9:28 p.m., 9:30 p.m., 9:32 p.m., and 9:34 p.m., and not by LVN 3. During a review of the Department Licensing and Certification Division Declaration form, executed and signed by LVN 3 on 8/22/2024 at 10:50 a.m., LVN 3 stated, “The visit notes that have been documented on 8/9/24 and 8/16/24 were NOT documented by myself (LVN 3) but by my boss (DPCS) on 8/20/24 between the hours of 8-10 pm…in addition there are no route sheets signed by the patient for these visits. Also all of my notes for (Patient 26) (6/10, 6/14, 6/18, 6/21, 6/26, 7/11, 7/19, 7/26) have all been altered and forged from the start of his care including (RN 1) & PT (physical therapy) notes by my boss (DPCS). I have screenshots showing the time and date my boss (DPCS) altered these notes and forged my signature on 8/20 between the hours of 8pm-10pm. The patient is not total care, he never hired a caregiver to take care of him in home. The patient walks, talks, can drive, can perform his ADLs on his own, and has denied pain at every visit”. During a phone interview, on 8/22/2024 at 12:10 p.m., with LVN 3, LVN 3 stated the agency’s EHR Document History section for each patient records like nurses’ assessment, visit notes, and supervisory visit notes will indicate the date, time, and the name of the HHA staff that created, accessed, added, and made modifications to the patient’s clinical records. LVN 3 further stated she never charted in all caps and that is when she recognized all her visit notes was altered when she found all her visit notes for Patient 26 from June 2024 has documentation in all caps. During a review of Patient 26’s electronic health record (EHR) “Document History” of the OASIS E Start of Care Assessment, dated 6/7/2024, it indicated RN 1 submitted the OASIS assessment on 6/11/2024. The EHR document history indicated the DPCS accessed and made modifications 37 times to the OASIS assessment on 8/20/2024 from 5:20 p.m. to 6:23 p.m. During a review of Patient 26’s EHR “Document History” of the OASIS E Recertification Assessment, dated 8/1/2024, it indicated RN 1 submitted the OASIS assessment on 8/12/2024. The EHR document history indicated the DPCS accessed and made modifications 21 times to the OASIS recertification assessment on 8/20/2024 from 7:02 p.m. to 7:45 p.m. During a review of Patient 26’s “LVN-LPN Supervisory Note”, dated 7/11/2024, the supervisory note indicated that it showed that was conducted and submitted by RN 1. However, the supervisory note was electronically signed by the DPCS, and the LVN-LPN Supervisory Note EHR Document history indicated RN 1 never created and accessed the supervisory note, but it was the DPCS who accessed the record 3 times on 8/20/2024 and submitted the record on 8/20/2024 at 8:30 p.m. During a review of Patient 26’s ““SN Visit Note with Wound Care” EHR Document History, dated 6/10/2024, 6/14/2024, 6/18/2024, 6/21/2024, 6/26/2024, 6/28/2024, 7/11/2024, 7/19/2024, and 7/26/2024 signed and submitted by LVN 3, indicated the DPCS accessed and made modifications to these records 61 times in total, on 8/20/2024 from 7:58 p.m. to 9:25 p.m. During a concurrent interview and record review on 8/22/2024, at 2:27 p.m. with the physical therapist (PT 1), PT 1 reviewed her notes titled, “PT Eval-Care Plan” dated 6/13/2024. PT 1 stated she only saw Patient 26 one time for an evaluation and her evaluation notes looks questionable now because Patient 26 was not homebound, but the PT note indicated Patient 26 was unable to leave home due to NWB restrictions to LLE and LUE. PT 1 stated most likely her PT evaluation note on 6/13/2024 had been altered because under the section “Homebound Status”, almost all the documentation was in all caps and that she never writes and documents in all caps. b. During a close record review of Patient 28’s Patient Information sheet, the Patient Information sheet indicated Patient 28's start of care date was 8/31/2023. During a review of Patient 28’s Home Health Certification and POC form for the certification period from 8/31/2023 to 10/29/2023, indicated patient’s diagnoses which includes encounter for surgical aftercare following a surgery, and pressure ulcer (an injury that breaks down the skin and underlying tissue) of right and left buttocks. The POC included an order for the skilled nurse to visit the patient two times a week for 5 weeks, and then once a week for 4 weeks for the comprehensive assessment and evaluation of all body systems, establishment of plan of care and treatment, and implementation of physician’s orders. During a review of Patient 28’s ““SN Visit Note with Wound Care”, dated 9/1/2023, signed and submitted by LVN 3 on 9/3/2024, indicated Patient 28 had a pressure ulcer wound on the left buttock, not stage, measuring 3 centimeter (cm, a unit of measure) in length and 2.5 cm in width, and the wound was cleansed with normal saline (NSS, a mixture of salt and water used in cleaning wounds), and was covered with mepilex (an absorbent foam dressing) boarded dressing. The visit note further indicated Patient 28 had a pressure ulcer wound on the right buttock, not stage, measuring 3 cm by 2.5 cm, and the wound was cleansed with NSS and covered with mepilex dressing. During a review of Patient 28’s ““SN Visit Note with Wound Care”, dated 9/6/2023, signed and submitted by LVN 3 on 9/10/2024, indicated Patient 28 had a pressure ulcer wound on the left buttock, stage 1 (non-blanchable redness of a localized area over a bony prominence) measuring 3 cm by 2.5 cm, and the wound was cleansed with NSS, and was covered with mepilex dressing. The visit note further indicated Patient 28 had a stage 1 pressure ulcer wound on the right buttock measuring 3 cm by 2.5 cm, and the wound was cleansed with NSS and covered with mepilex dressing. During a review of Patient 28’s ““SN Visit Note with Wound Care”, dated 9/8/2023, signed and submitted by LVN 3 on 9/10/2024, indicated Patient 28 had a pressure ulcer wound on the left buttock, not stage measuring 2 cm by 2 cm, and the wound was cleansed with NSS, and was covered with mepilex dressing. The visit note further indicated Patient 28 had a pressure ulcer wound on the right buttock, not stage measuring 2 cm by 2 cm, and the wound was cleansed with NSS and covered with mepilex dressing. During a review of the Department Licensing and Certification Division Declaration form, executed and signed by LVN 3 on 8/21/2024 at 4 p.m., LVN 3 stated, “The patient (Patient 28) was seen by myself on 9/1/2023, 9/6/2023, and 9/8/2023 at his vacation home in Lake Arrowhead. During my visit with the patient I asked if he had any pressure ulcers or wounds. He and his daughter explained he had one but it was healed and they were putting a butterfly optifoam bandage (an adhesive foam dressing) on it prophylactically (to prevent or protect against a disease or infection). I examined the patients left and right buttox and his skin was intact, no pressure wound was present and he did not need wound care…When my boss (DPCS) called to question my documentation she told me she did his OASIS start of care and asked why the wounds weren’t documented. I explained there weren’t any and no wound care was needed. She got upset w/ me and stated he had been chosen for survey and asked if I got pictures which I didn’t need to because there was no wound present. She then explained that she would have to figure something out & fix it since he was chosen for survey. Upon checking she forged and altered my documentation of the visits listed above...She changed and added info to state he had a wound, wound care was completed, and didn’t have pictures. This is the second patient of mine who was chosen for state survey whose documentation was altered and forged by my boss (DPCS).” During a review of Patient 28’s ““SN Visit Note with Wound Care” EHR Document History, dated 9/1/2023, 9/6/2023, and 9/8/2023, indicated the DPCS accessed and made modifications to these records 30 times in total, on 9/12/2023 from 4:31 p.m. to 5:12 p.m. and on 9/13/2023 from 10:11 a.m. to 11:58 a.m. During a concurrent record review and interview with the DPCS, on 8/23/2024 at 11:05 a.m., the DPCS reviewed EHR of Patient 26 and Patient 28. The DPCS was unable to provide an explanation why there was a visit note on the patient’s chart when Patient 26 stated he was not visited on those dates and LVN 3 stated she did not visit Patient 26 nor submitted a visit note on 8/9/2024 and 8/16/2024. The DPCS was unable to provide an explanation as to why it appears on Patient 26’s EHR that LVN 3 submitted SN visit notes on 8/9/2024 and 8/16/2024 but the EHR document history indicated it was her and not LVN 3 accessed those records. The DPCS was unable to provide an explanation why Patient 26’s OASIS SOC and Recert assessment in the EHR does not match what RN 1 documented on the paper form of her initial and recertification visits. The DPCS was unable to provide an explanation why she accessed Patient 28 visit notes multiple times on 9/12/2023 and 9/13/2023, and why she accessed Patient 26 clinical records which includes SN visit notes, OASIS assessment, and Lvn supervisory visits multiple times on 8/20/2024 between 5:20 p.m. to 9:34 p.m. During a review of the agency’s policy and procedure (P&P) titled, “Safeguarding/Retrieval of Clinical Record,” revised November 2022, the P&P indicated that the organization will safeguard the clinical records against loss, destruction, tampering, or unauthorized use through the development of processes, policies, and procedures. The clinical record will be safeguarded in compliance with Health Insurance Portability and Accountability (HIPPA) privacy requirements.

The following reflects the findings of the California Department of Public Health during the Complaint Validation Survey on 4/2/2024 to 4/8/2024 at 2347 Honolulu Avenue Montrose, CA 91020. Complaint number: 101420 Complaint number: 103263 Complaint number: 104434 Representing the Department of Public Health: Health Facilities Evaluator Nurse: #44916 Health Facilities Evaluator Nurse: #44186 Health Facilities Evaluator Nurse: #19096 The Inspection was limited to the specific for the complaint investigated and does not represent the findings of a full inspection of the facility. Active Census: 2568 Sample size :18 Home visits: 7 Record reviews: 11 On 4/5/2024 at 3:48 p.m., an Immediate Jeopardy (IJ, a situation that has threatened or is likely to threaten the health and safety of a resident) was called in the presence of the HHA’s Administrator/Director of Patient Care Services (ADM/DPCS) related to the HHA’s failure to ensure to notify MD 1 of Patient 6 who missed wound care home nursing visits for daily wound care and failed to update Patient 6’s plan of care that could lead to infection, hospitalization, and death. On 4/8/2024, at 8:42 a.m., the agency submitted the IJ removal plan, and the survey team reviewed, and the agency was informed that the IJ removal plan (the facility’s plan of action to correct the deficient practices), was not acceptable on 4/8/2024, at 11:31 a.m. On 4/8/2024, at 2 p.m., the survey team completed the survey tasks and conducted an exit conference with the ADM/DPCS and the IJ was not removed. On 6/17/2024, at 3:25 p.m., the survey team conducted an onsite verification of the HHA's acceptable IJRP and the IJ was removed in the presence of the ADM/DPCS. The IJRP as follows: 1.On 4/5/2024, the HHA reported to Patient 6’s Medical Doctor the HHA was unable to contact Patient 6. 2.On 4/5/2024, the HHA reported to the Adult Protective Services (APS) the HHA was unable to contact Patient 6. 3.On 4/5/2024, the HHA reported to the local police, the HHA was unable to contact Patient 6. 4.On 4/5/2024, at 4:15pm, the DPCS connected with the patient in the presence of CDPH surveyors. A follow-up visit was arranged right away, within the next hour. The visiting nurse and the DPCS designee made a joint supervisory visit. A comprehensive wound care assessment was done, pictures were taken, and measurements were made. The left leg amputation surgical wound measured 10 cm x 6.5 cm x 0.1 cm LWD and the diabetic ulcer wound to the left leg measured 2.2 cm x 1.0 cm x 0.1 cm LWD. SN performed wound care per physician orders. 5.On 4/5/2024, patient education was provided regarding the importance of following physician orders and ensuring that wound care is done daily as ordered by the MD. The patient was instructed regarding the dangers of missing wound care due to his high-risk status of diabetes and dialysis. The patient stated that he could do his wound care on days he refused the wound care nurse. However, it is hard for him to do it. 6.On 4/6/2024, a nurse educator with no prior work experience at the HHA, who specializes in home health and hospice education, conducted in-service training regarding managing patients with wounds, policies, and procedures for wound care, documentation, assessment, measurement, and notification of physicians regarding any missed wound care to prevent hospitalization or any other adverse events or poor patient outcomes. 7.on 4/6/2024, the agency ran a missed visit report for patients with wounds, diabetes, and dialysis. From the report, 24 patients were identified as having missed visits. The agency conducted record reviews for the 24 patients to ensure that missed visits were appropriately reported to MD. 8.On 4/7/2024, the agency initiated an organization-wide Performance Improvement Project, PIP, to improve the care provided to wound care patients. 9.On 4/8/2024, the agency concluded the 24 record reviews of wound care patients with missed visits and ensured that there was documented evidence of physician notification whenever a visit was missed. 10.On 4/8/2024, the agency was able to validate that no other patients were affected by this practice 11.On 4/11/2024, the HHA discharged Patient 6 due to not meeting homebound criteria. 12.On 4/11/2024, the General Acute Care Hospital social worker and set up patient #6 for outpatient wound clinic. 13.On 04/12/2024, the HHA hired three Registered Nurse case managers to manage wound care patients 14. On 4/19/2024, the HHA insured that all 18 patients with missed visits had follow up assessments completed to insure proper wound care and healing. 15. On 4/19/2024, the HHA ensured that all 18 patients follow up visits were done, and no other patients were affected. 16. As of 04/19/2024, the HHA’s current census is 1966, since the agency is not actively admitting patients. The Following Conditions of Participation not met: 484.55 Comprehensive Assessment of Patients 484.60 Care planning, Coordination and Quality of care 484.110 Clinical records

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to ensure the Condition of Participation for Comprehensive Patient Assessment of Patients was not met as follows: The home health agency (HHA) nursing staff failed to ensure a comprehensive wound assessment was conducted that included the location, size, drainage, color, odor, and appearance of the wound bed in accordance with the home health policy and procedure for one of 18 sampled patients (Patient 5). This deficient practice had the potential in the delayed provision of wound treatment that could lead to infection and deterioration of the wounds causing patient's discomfort and/or pain. (Refer to G528). The home health agency (HHA) failed to review all medications the patient is currently using and maintained an accurate and current medication profile for 1 of 18 patients (Patient 7). Refer to G536.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(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) nursing staff failed to ensure a comprehensive wound assessment was conducted that included the location, size, drainage, color, odor, and appearance of the wound bed in accordance with their policy and procedure for one of 18 sampled patients (Patient 5). This deficient practice had the potential in the delayed provision of wound care treatment that could lead to infection and deterioration of the wounds causing patient's discomfort and/or pain. Findings: During a closed record review of Patient 5's Patient Information sheet indicated a start of care (SOC) date of 11/08/2023, with a diagnoses including essential hypertension (high blood pressure), venous insufficiency (improper functioning of the leg veins [blood vessels that carry oxygen-poor blood to your heart] causing swelling and skin changes), and history of falling. During a review of Patient 5’s Home Health Certification and Plan of Care (document used to establish the patient's treatment plan for the initial certification period and any continued sixty-day recertification periods) for the certification period from 1/7/2024 to 3/6/2024, included an order for the skilled nurse (SN) to visit the patient two times a week for 9 weeks to perform assessment and observation of each body system, medication compliance, and instruct patient/patient caregiver on infection control/pressure relief measures and skin care. During a review of Physician's Order dated 1/11/2024, indicated the SN reported Patient 5 had a new wound on left shin measuring 5 cm (centimeter, a unit of measure) by 6 cm water blister (an area of skin covered by a raised, fluid-filled bubble). The physician's order was received to cleansed the wound with wound cleanser, pat to dry, apply A&D ointment (medication used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations) to peri wound (the skin around the wound) and dry areas, apply Medi honey alginate (used to hastens the healing of wounds) to open blister, cover with Mepilex (a type of wound dressing), then wrap with profore (compression bandage) 3 layer wrap two times a week for 3 weeks then reassess. During a review of Patient 5’s clinical record indicated a completed wound assessment on the new wound on the left shin was not done that includes the location, size, drainage, color, odor, and appearance of the wound bed. During a concurrent interview and record review, on 4/04/2024 at 2:45 p.m., with the Director of Patient Care Services Designee (DPCSD), the DPCSD stated she was not able to find the documented evidence the new wound on left shin was assessed by the visiting nurse. The DPCSD stated the patient's wound should have been assessed that includes the location, size, drainage, color, odor, and appearance of the wound bed. During a review of the agency's undated policy and procedure titled "Wound Assessment and Documentation”, indicated to inspect and evaluate the condition of the wound in the following manner: - Assess the wound location and its size - Assess the color of the wound bed - Assess wound drainage - Assess wound odor - Assess the surrounding skin for redness, or inflammation, or signs of breakdown All new wounds must be assessed by a registered nurse to complete a comprehensive wound assessment and report to MD (physician) and update the plan of care.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to review all medications the patient is currently using and maintained an accurate, and current medication profiles for 1 of 18 patients (Patient 7). This failure has the potential to result in placing the patient at risk for medication errors and adverse drug reactions. 1. A review of Patient 7's Patient Profile Information indicated, a start of care (SOC) date of 10/24/2023, with a certification period of 2/21/2024 to 4/20/2024. Patient 7's diagnosis included type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar) with non-pressure chronic ulcers (an open sore in the skin) A joint home visit was conducted on 4/4/2024 at 8 a.m., with Registered Nurse 1(RN 1). RN 1 stated that Patient was not at home and will be back in 15 to 20 minutes. Patient 1 arrived driving a white pick-up truck. Upon arrival Patient 7 was observed to walk without assistance, sat in a recliner in the living room area, alert and oriented to name, place, and time, not in any respiratory distress. During a review of Patient 7's medications currently taking reconciling with the medication profile on 4/4/2024, at 8:45 a.m., indicated the following medications were not updated in the medication profile: 1. Vitabex Iron 65 mg iron 1 tablet twice daily was changed to once daily as supplement. 2. Metolazone 2.5 mg 1 tablet daily for swelling 3. Pioglitazone 15 mg 1 tablet daily for diabetes. During an interview with RN 1 on 4/4/2024 at 9 a.m., RN 1 stated she reviews medications at least once a month. RN 1 stated she always ask the patient on a regular basis during wound care if he has new medications prescribed. RN 1 acknowledged “I am not the nurse that would document in the patient’s handbook every time there are updates in the medications, I am guilty for that”. RN 1 stated that the wife was on top of the medications for the patient. During an interview with Director of Nursing Designee (DOND) on 4/4/24 at 11:19 a.m., DOND stated that she supervised the case managers for the agency’s patients. DOND stated that she was on top of issues and concerns and that she encouraged field staff to document in the patient’s electronic medical record for any problems they encountered out in the field. DOND stated staff should conduct reconciliation for medications during start of care (SOC), Resumption of care and recertification of care. DOND stated staff should ask the patient’s family/patient if there are new medications, and the RN needs to update the medication profile. A review of the HHA’s policy titled “Ongoing Assessments” Revised 4/2017 indicated that During each home visit the clinician or other discipline will re-evaluate the patient according to the problems identified during the initial visit and subsequent visits. Using the standards of are identified by the organization, the clinician will reassess the patient (as appropriate) for: Compliance with treatment and/or medications.

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 observation, interview, and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation (refer to the requirements that healthcare organizations must meet to participate in federal healthcare programs) regarding Care Planning, Coordination, Quality of Care was met as follows: The HHA failed to notify one of 18 sampled patients (Patient 6) Medical Doctor 1 (MD 1) of Patient 6’s seven missed wound care home visits and update Patient 6’s plan of care. As a result, Patient 6 did not receive daily wound care home visits for seven days without MD1 knowing and placed Patient 6 at risk for infection that could lead to further amputation (cutting off a limb [arm or leg]), hospitalization, and death. (Refer to G590). The home health agency (HHA) failed ensure Plan of Care (POC) was signed and dated by the physician within 30 days of start of care for 11 out of 18 sampled patients (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9 ,10, and 11) certified to receive home health services. This failure had the potential risk for the physician not aware of the accuracy of the care, treatment, and services ordered by the physician identified in the POC. (Refer to G 572) The Home Health Agency (HHA) failed to ensure a copy of the current plan of care (POC- information identified based upon the patient identified needs and development of appropriate interventions) was provided to two of 18 sampled patients (Patient 1 and Patient 2). This failure had the potential in a lack of coordination of the plan of care with the patient and other clinicians involved in the patient care and treatment. (Refer to G 612) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated (in a way that is decided and controlled by law) compliance with the Federal (government) Regulations for Care Planning, Coordination, Quality of Care, to ensure the provision of health care services in a safe manner.

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 ensure Plans of Care (POC) were signed and dated by the physician within 30 days of start of care for 11 out of 18 sampled patients (Patients , 3, 4, 5, 6, 7, 8, ,9 ,10, and 11) certified to receive home health services. This failure resulted in the provision of home health services to certified patients without a signed and dated POC indicating approval from the physician or allowed practitioner. Findings: a. During a review of Patient 1's Patient Information sheet indicated a start of care date (SOC) of 12/7/2023, with a diagnosis of unspecified open wound, left foot. During a review of Patient 1’s Home Health Certification and Plan of Care (POC, document used to establish the patient's treatment plan for the initial certification period and any continued sixty-day recertification periods) for the certification period from 2/05/2024 to 4/04/2024, included an order for the skilled nurse (SN) to visit the patient every day to perform assessment and observation of each body system, and to perform wound care on left foot and right foot wound. Further review of the POC indicated that the area for the physician signature was blank. b. During a review of Patient 2’s Patient Information sheet indicated a SOC date of 12/12/2023, with diagnosis of other chronic pain. During a review of Patient 2’s Home Health Certification and Plan of Care for the certification period from 2/10/2024 to 4/09/2024, included an order for the skilled nurse to visit the patient three times a week for 9 weeks to perform assessment and observation of each body system, medication compliance, and wound care management. Further review of the POC indicated that the area for the physician signature was blank. c. During a review of Patient 3's Patient Information sheet indicated a SOC date of 2/29/2024, with a diagnosis of hemiplegia (paralysis of one side of the body) following a cerebral infarction (also known as a stroke, refers to damage to tissues in the brain due to a loss of oxygen to the area). During a review of Patient 3’s Home Health Certification and Plan of Care for the certification period from 2/29/2024 to 4/28/2024, included an order for the skilled nurse (SN) to visit the patient two times a week for 5 weeks, and then once a week for 4 weeks to perform assessment and observation of each body system, assess pain level and effectiveness of pain medications, and to teach patient/patient caregiver on medication management, current medications’ actions/potential adverse reactions (unwanted undesirable effects) and compliance. Further review of the POC indicated that the area for the physician signature was blank. d. During a review of Patient 4's Patient Information sheet indicated a SOC date of 3/03/2024, with a diagnosis including type 2 diabetes mellitus (a condition that results in too much sugar circulating in the bloodstream), essential hypertension (high blood pressure), and chronic obstructive pulmonary disease (COPD-a group of lung diseases that block airflow and make it difficult to breathe). During a review of Patient 4’s Home Health Certification and Plan of Care for the certification period from 3/03/2024 to 5/01/2024, indicated that the area for the physician signature was blank. e. During a closed record review of Patient 5's Patient Information sheet indicated a SOC date of 11/08/2023, with a diagnosis including essential hypertension, venous insufficiency (improper functioning of the leg veins [blood vessels that carry oxygen-poor blood to your heart] causing swelling and skin changes), and history of falling. During a review of Patient 5’s Home Health Certification and Plan of Care for the certification period from 1/07/2024 to 3/06/2024, included an order for the skilled nurse (SN) to visit the patient two times a week for 9 weeks to perform assessment and observation of each body system, medication compliance, and instruct patient/patient caregiver on infection control/pressure relief measures and skin care. Further review of the POC indicated that the area for the physician signature was blank. During a concurrent record review and interview with the Administrator/Director of Patient Care Services (ADM/DPCS), 4/8/2024 at 1:10 p.m., she stated that plan of care should be signed by a physician within 30 days from the SOC. During a review of the agency’s policy and procedure titled “Care Planning Process,” revised November 2022, indicated a written individualized plan of care will be initiated within five days of start of care and updated at least every 60 days, or as patient’s condition warrants. All clinicians including the physician (or other authorized licensed independent practitioner) involved in the patient's care, either directly or indirectly, will contribute to the plan of care. The plan of care shall be signed by a Doctor of Medicine, osteopathy, or pediatric medicine, or an allowed practitioner acting within the scope of a state license, certification, or registration. f. During a review of Patient 6's Patient Information sheet indicated an SOC of 3/19/2024, with a certification period of 3/19/2024 to 5/17/2024. Patient 6's diagnosis included type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar) with hemodialysis (a procedure where a dialysis machine and a special filter called an artificial kidney, or a dialyzer, are used to clean your blood) with left foot amputation (the removal of a leg, foot or toes from the body). During a review of Patient 6’s Home Health Certification and Plan of Care for the certification period from 3/19/2024 to 5/17/2024, included an order for the skilled nurse (SN) to visit the patient every day to perform assessment and observation of each body system, and to perform wound care on left foot and right foot wound. Further review of the POC indicated that the area for the physician signature was blank. g. During a review of Patient 7’s Patient Information sheet indicated a SOC date of 10/24/2023, with diagnosis of type 2 diabetes and wound care. During a review of Patient 7’s Home Health Certification and Plan of Care for the certification period from 10/24/2023 to 12/22/2023, included an order for the skilled nurse to visit the patient three times a week for 9 weeks to perform assessment and observation of each body system, medication compliance, and wound care management. Further review of the POC indicated that the area for the physician signature was blank and was in draft form. For the certification period of 2/21/2024 to 4/20/2024 review of the POC indicated that the area for the physician signature was blank. h. During a record review of Patient 8's Patient Information sheet indicated a SOC date of 1/5/2024 with a diagnosis including unspecified wound of the abdominal wall During a review of Patient 8's Home Health Certification and Plan of Care for the certification period from 1/5/2024 to 3/4/2024 and 3/5/2024 to 5/5/2024, included an order for the skilled nurse (SN) to visit the patient two times a week for 9 weeks to perform assessment and observation of each body system, medication compliance, and instruct patient/patient caregiver on infection control/pressure relief measures and skin care. Further review of the POC indicated that the area for the physician signature was blank. i. During a closed record review of Patient 9's Patient Information sheet indicated a SOC date of 8/5/2023, with a diagnosis including type 2 diabetes with dialysis. During a review of Patient 9’s Home Health Certification and Plan of Care for the certification period from 8/5/2023 to 10/3/2023 and 12/3/2023 to 1/31/2024, included an order for the skilled nurse (SN) to visit the patient two times a week for 9 weeks to perform assessment and observation of each body system, medication compliance, and instruct patient/patient caregiver on infection control/pressure relief measures and skin care. Further review of the POC indicated that the area for the physician signature was both blank. j. During a closed record review of Patient 10's Patient Information sheet indicated an SOC date of 7/6/2023, with a diagnosis including chronic pain. During a review of Patient 10’s Home Health Certification and Plan of Care for the certification period from 7/6/2023 to 9/3/2023, included an order for the skilled nurse (SN) to visit for evaluation and discharge visits only to perform assessment and observation of each body system, medication compliance, and instruct patient/patient caregiver on infection control/pressure relief measures and skin care. Further review of the POC indicated that the area for the physician signature was blank. k. During a closed record review of Patient 11's Patient Information Sheet indicated an SOC date of 5/31/2023 with the diagnosis of ulcer of the anus and rectum (a break in the skin or mucous membrane along with loss of tissue at the surface. Ulcers can occur on and within the body, including along the lining of the colon and rectum, and on the anus). During a review of Patient 11’s Home Health Certification and Plan of Care for the certification period from 5/31/2023 to 7/29/2023, included an order for the skilled nurse (SN) to visit for twice a week for one week and once a week for two weeks to perform assessment and observation of each body system, medication compliance, and instruct patient/patient caregiver on infection control/pressure relief measures and skin care. Further review of the POC indicated that the area for the physician signature was blank. During a concurrent record review and interview with the Administrator/Director of Patient Care Services (ADM/DPCS), 4/8/2024 at 1:10 p.m., she stated the plan of care and other patient records should all be signed and dated. During a joint interview on 4/8/2024 at 12:30 p.m., with the Administrator Designee (ADD) and project Manager for Medical Records (PM) stated they work together to improve the digital processing of the electronic medical record (EMR- are a digital version of the paper charts in the clinician's office) and upgrades. ADD further stated they have 30 days to upload the POC in the EMR. Per PM stated that the POC is faxed out to the physician for signature via their program. Per ADD, her team follows up with the physician's regularly, leaves them messages in their call center. Per ADD , stated that "our daily check is making sure that the orders and other forms are signed and uploaded in the EMR. A review of the HHA's document titled " Entries in the Clinical Record" revised April 2017 indicated Home health personnel providing direct patient care and supervisory functions have authority to make entries into the clinicaI 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. Note: Times means actual t me that an event occurred, which is not necessarily the time when the documentation was entered into the record. The date and time requirement applies to all entries in the record and the medical record should accurately reflect a clear account of the patient's entire course of ca e. The clinical record should tell a linear story of the course of the patient's care that is managed and delivered by the organization. Based on the findings of the reassessment, additional orders will be generated and forwarded to the physician ( or other authorized licensed independent practitioner) for signature(s).

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to notify one of 18 sampled patients (Patient 6) Medical Doctor 1 (MD 1) of Patient 6’s seven missed wound care home visits and failed to update Patient 6’s plan of care. As a result, Patient 6 did not receive daily wound care home visits for seven days without MD1 knowing and placed Patient 6 at risk for infection that could lead to further amputation (cutting off a limb [arm or leg]), hospitalization, and death. On 4/5/2024 at 3:48 p.m., an Immediate Jeopardy (IJ, a situation that has threatened or is likely to threaten the health and safety of a resident) was called in the presence of the HHA’s Administrator/Director of Patient Care Services (ADM/DPCS) related to the HHA’s failure to ensure to notify MD 1 of Patient 6 who missed wound care home nursing visits for daily wound care and failed to update Patient 6’s plan of care that could lead to infection, hospitalization, and death. On 4/8/2024, at 8:42 a.m., the agency submitted the IJ removal plan, and the survey team reviewed, and the agency was informed that the IJ removal plan (the facility’s plan of action to correct the deficient practices), was not acceptable on 4/8/2024, at 11:31 a.m. On 4/8/2024, at 2 p.m., the survey team completed the survey tasks and conducted an exit conference with the ADM/DPCS and the IJ was not removed. Findings: During a review of Patient 6’s Home Health Certification and Plan of Care with the certification period of 3/19/2024 to 5/17/2024, the Home Health Certification and Plan of Care indicated a start of care (SOC) date of 3/19/2024 with diagnoses including of Type 2 Diabetes (a medical condition characterized by the body's inability to regulate blood sugar levels), gangrene (death of body tissue due to a lack of blood flow or a serious bacterial infection) and dependence on renal (refers to the kidney) dialysis (is a treatment to filter wastes and water from the blood ). During a review of Patient 6’s Plan of Treatment Physician Order, with the certification period for 3/19/2024 to 5/17/2024, the Plan of Treatment Physician Order indicated for the SN to do daily wound care on Patient 6’s left foot amputation site measuring at 9 (nine) centimeters (cm, a unit of measurement) by 7 (seven) cm with heavy sanguineous drainage (the leakage of fresh blood produced by an open wound). The Plan of Treatment Physician Order indicated for the SN to cleanse (refers to the use of fluid solutions to remove bacterial debris and other foreign contaminants from the wound) Patient 6’s amputation site wound with Vashe (wound cleanser), pat dry, apply Hydrofera Blue (wound protection dressing [materials applied to wounds to promote healing]) moistened dressing, cover with an abdominal (ABD, extra thick dressing designed to care for moderate to heavily draining wounds) pad, wrap with kerlix (a soft gauze), and secure with tape. The Plan of Treatment Physician Order indicated for the SN to do wound care daily for 21 days then for the SN to reassess and relay reassessment findings to the Medical Doctor (MD). The Plan of Treatment Physician Order indicated for the SN to teach the patient/PCG on signs and symptoms of infection and proper wound care procedures. During a review of Patient 6’s Plan of Treatment Physician Order, with the certification period for 3/19/2024 to 5/17/2024, the Plan of Treatment Physician Order indicated for the SN to do daily wound care on Patient 6’s lower left leg site measuring at 2 cm by 1.50 cm with heavy sanguineous drainage. The Plan of Treatment Physician Order indicated for the SN to cleanse with Vashe, pat dry, moistened dressing, cover with an ABD pad, wrap with kerlix, and secure with tape. The Plan of Treatment Physician Order indicated for the SN to do wound care daily for 21 days then for the SN to reassess and relay reassessment findings to the MD. The Plan of Treatment Physician Order indicated for the SN to teach the patient/PCG on signs and symptoms of infection and proper wound care procedures. During a review of Patient 6’s Home Health Certification and Plan of Care Orders with the certification period reviewed for 3/22/2024 to 5/20/2024, the Home Health Certification and Plan of Care Orders indicated for the Skilled Nurse (SN) to visit Patient 6 as follow: SN two visits every one week for one week starting week one, six visits every one week starting week two, seven visits every one week for two week starting week three, four visits every one week for one week starting week five, two visits every one week for three week starting week six. During a review of Patient 6’s Home Health Certification and Plan of Care Integumentary (skin) Status with the certification period for 3/22/2024 to 5/20/2024, the Home Health Certification and Plan of Care Integumentary Status indicated for the SN to assess/instruct patient/patient caregiver (PCG) on pressure relief measures including change position every two hours, pad bony prominences (areas where bones are close to the surface), offload heels, moisturize skin after bathing, smooth out wrinkles in sheets, and ensure proper hydration. During a joint home visit observation and an interview on 4/4/2024, at 10 a.m., with Registered Nurse 1 (RN1) at Patient 6’s residence, RN1 stated Patient 6 was not at home. RN 1 stated Patient 6 agreed to the home visit on 4/3/2024 and Patient 6 did not answer on 4/4/2024. During the concurrent observation, RN 1 knocked on Patient 6’s door and rang the doorbell three times and there was no answer. RN1 and the surveyor stayed in Patient 6’s residence for thirty minutes and called the patient two times and Patient 6 did not answer. During an interview on 4/4/2024, at 10:30 a.m., with RN 1, RN 1 stated Patient 6 was “very noncompliant,” with the home visits and wound care. RN 1 stated “I am afraid that the patient would be septic (dangerous reaction to an infection).” RN 1 presented her route sheet and stated that on 3/24/2024, 3/25/2024, 3/27/2024, 3/30/2024, 4/3/2024, and on 4/4/2024 Patient 6 was not visited for wound care. RN 1 stated that she (RN1) she would call the office and notified the case manager and the office coordinated with the doctor regarding Patient 6’s missed home visits. During an interview on 4/4/2024, at 11:19 a.m., with the Director of Nursing Designee (DOND), the DOND stated she would oversee the case managers for the patients (in general) in the HHA. The DOND stated she was on top of any issues and concerns regarding the HHA’s patients. The DOND stated the office and field staff used a form of communication for any concerns and updates for patient care. During a joint interview 4/4/2024, at 1:28 p.m., with the ADM/DPCS, and the DOND, the ADM/DPCS stated RN 1 reported a couple of times of Patient 6’s missed home visits (unidentified dates). The ADM/DPS stated the HHA used a messaging system to communicate with the doctors (in general). When asked if MD1 was notified for Patient 6’s missed home visits, the ADM/DPCS stated “yes.” The ADM/DPCS stated she did not receive any new orders or changes in the visit frequency for Patient 6. The ADM/DPCS stated the HHA did not develop Patient 6’s care plan for noncompliance with home visits and wound care. The ADM/DPCS stated the outcome for Patient 6’s noncompliance could lead to no wound care on the missed visit dates. The ADM/DPCS stated the HHA did not provide a wound consult. During a telephone interview on 4/4/2024, at 5:30 p.m., with the Service Line Administrator (SLA), the SLA stated the HHA should have called Patient 6’s Physician, MD1, directly for any critical inquiries for the HHA’s patients, especially the high-risk patients. During a joint interview on 4/5/2024, at 11:50 a.m., with the ADM/DPCS and the DOND, the ADM/DPCS stated the HHA was able to call Patient 6’s dialysis center and learned that Patient 6 refused to go to his dialysis on 4/3/2024 and on 4/5/2024. The DON stated they needed to notify MD 1 to transfer Patient 6 to a higher level of care. During a telephone interview on 4/5/2024, at 11:53 a.m., with RN 1, RN 1 stated Patient 6 was not home on 4/5/2024. During a telephone interview on 4/5/2024, at 2:45 p.m., with MD1, MD1 stated the HHA did not notify him of Patient 6’s missed wound care home visits. MD 1 stated he was available 24 hours a day seven days a week. A review of the HHA’s document titled, “Care Coordination” revised 4/2017, indicated to ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services. Each patient will be assigned a Case Manager upon admission by the Clinical Director or Clinical Supervisor. It will be the responsibility of the Case Manager to facilitate communication about changes in the patient status among assigned personnel. Timely and ongoing communication is the responsibility of each team member, will be appropriate to the needs and abilities of the patient, and will be relevant to the care provided. The clinicians will be responsible for facilitating communications about changes in the patient's status among the assigned personnel. Written evidence of care coordination will be recorded during the case conference and repeated in skilled nursing visit report in the patient's clinical records. All organization personnel involved in patient care, including those providing contracted services, will have access to the plan of care and all other relevant patient information to ensure coordination and continuity of care. All personnel will be knowledgeable regarding patient needs, goals of care and services. Contract personnel will participate in preparation of the plan of care, submit documentation on services provided, including clinical notes, schedule of visits, and patient evaluations, on a weekly basis; and participate in multidisciplinary case conferences when a patient in their caseload is being discussed. Organization personnel will communicate changes in a timely manner via telephone, one to one meetings, case conferences and home visits. Documentation of all communications will be included in the clinical record on a communication note, case conference summary, or clinical note. Documentation will include: the date and time of the communication, individuals involved with the communication, information discussed, and the outcome of the communication. A review of the HHA’s document titled, “Physician Participation in Plan of Care” revised 11/2022, indicated a physician will direct the care of every home health patient admitted for service. The attending physician will certify that medical, skilled, rehabilitation, and social services provided by the organization are medically necessary and meets the requirements to be covered by Medicare. The attending physician (or other authorized licensed independent practitioner) will participate in the care planning process by reviewing and revising the plan of care (therapeutic and diagnostic orders). The care will be provided in compliance with his/her therapeutic and diagnostic orders and accepted standards and practice.

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 observation, interview, and record review, the Home Health Agency (HHA) failed to ensure a copy of the current plan of care (POC- information identified based upon the patient identified needs and development of appropriate interventions) was provided to two of 18 sampled patients (Patient 1 and Patient 2). This failure had the potential in a lack of coordination of the plan of care with the patient and other clinicians involved in the patient care and treatment. Findings: a. During a review of Patient 1's Patient Information sheet indicated a start of care date (SOC) date of 12/7/2023, with a diagnosis of unspecified open wound, left foot. During a review of Patient 1’s Home Health Certification and Plan of Care (document used to establish the patient's treatment plan for the initial certification period and any continued sixty-day recertification periods) for the certification period from 2/05/2024 to 4/04/2024, included an order for the skilled nurse (SN) to visit the patient every day to perform assessment and observation of each body system, and to perform wound care on left foot and right foot wound. On 4/3/2024 at 9 a.m., a home visit was conducted at Patient 1’s residence with a registered nurse (RN 1). Patient 1 was observed awake, alert, oriented x 3 (to person, place, and time), and ambulatory. During a review of Patient 1's home health agency folder located inside the patient’s house showed there was no copy of the current Home Health Certification and Plan of Care. On 4/3/2024 at 9:32 a.m., during an interview with Patient 1, Patient 1 stated he has no copy of his plan of care since the SOC and would appreciate it if the agency brings a copy to him. b. During a review of Patient 2’s Patient Information sheet indicated a SOC date of 12/12/2023, with diagnosis of other chronic pain. During a review of Patient 2’s Home Health Certification and Plan of Care for the certification period from 2/10/2024 to 4/09/2024, included an order for the skilled nurse to visit the patient three times a week for 9 weeks to perform assessment and observation of each body system, medication compliance, and wound care management. On 4/4/2024 at 10:05 a.m., a home visit was conducted at Patient 2’s residence with a licensed vocational nurse (LVN 1). Patient 2 was observed laying in a hospital bed, awake, alert, oriented x 2 (to place and time), has poor vision and was hard-of hearing. During a review of Patient 2's home health agency folder located inside the patient’s house showed there was no copy of the current Home Health Certification and Plan of Care. On 4/4/2024 at 10:35 a.m., during an interview with Patient 2’s caregiver (PCG 1), PCG 1 stated and confirmed there was no current copy of the POC available in the home of Patient 2. During an interview, on 4/06/2024 at 1 p.m., with the Administrator/Director of Patient Care Services (ADM/DPCS), the ADM/DPCS stated and agreed patients should have a current copy of their POC at home. During a review of the agency’s policy and procedure titled “Care Planning Process,” revised November 2022, indicated a written individualized plan of care will be initiated within five days of start of care and updated at least every 60 days, or as patient’s condition warrants. The patient and family/caregiver will participate in decisions regarding the plan of care whenever possible. The organization shall provide the patient and caregiver with a copy of written instructions outlining: a. Visit schedule, including frequency of visits by personnel and personnel acting on behalf of the organization. b. Patient medication schedule/instructions, including medication name, dosage and frequency and which medications will be administered by the organization's personnel and personnel acting on behalf of the organization c. Education on the safe use, storage and disposal of opioid medications d. Any treatments to be administered by the organization's personnel and personnel acting on behalf of the organization, including therapy services. e. Any other pertinent instruction related to the patient's care and treatments that the organization will provide, specific to the patient's care needs. f. Name and contact information of the organization's clinical manager.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency failed to track, monitor and evaluate adverse patient events and include them in the agency's performance improvement projects (PIP, a concentrated effort on a particular problem in one area of the facility or facility wide involving gathering of information systematically to clarify issues or problems, and intervening for improvements). This failure had the potential to affect the highest quality of care provided to all the patients certified to receive the home health benefits. A complaint validation survey was conducted at this agency location from 4/2/2024 to 4/8/2024. The agency's active census was 2568 patients. During the entrance conference on 4/2/2024, at 11 a.m., the team requested from the Administrator Designee their performance improvement projects (PIP) derived from the data collected from the Quality Assurance and Performance Improvement (QAPI, the coordinated application of two mutually‑reinforcing aspects of a quality management system. QAPI takes a systematic, comprehensive, and data‑driven approach to maintaining and improving safety and quality in nursing homes while involving all nursing home caregivers in practical and creative problem solving) program and complaint /grievance log to be reviewed. On 4/2/2024 at 12 p.m., during an interview with the QAPIPLUS Consultant/Chief executive officer/Founder (QAPIPLUSCEO) stated that the agency is in the process of migrating over to a different system and the current system they have could not handle the influx of their patients. QAPIPLUSCEO stated that they have to coordinate with the IT from Synergy to help them print out all the documents required. At 12:30 p.m., there was still no documented QAPI/PIP and grievance log was presented to the team onsite. On 4/4/2024 at 11 a.m., a follow up request for the QAPI/PIP and grievance logs was made known to the QAPIPLUS Coordinator and QAPIPLUS Coordinator Assistant. A review of their complaint log on 4/8/2024 revealed that the agency accumulated 28 complaints/grievances ranging from supplies delivery, medications, rehabilitation services , nursing visits, referral inquiries, admissions and insurance coverage issues from January to April 2024 alone. During an interview with the QAPIPLUS Founder/Chief Executive Officer on 4/7/2024, stated that QAPIPLUS is a quality management software solution with a QA functionality. Stated that when the clinicians submits a document, it pulls data from the documentations that clinicians enter in the electronic medical record and the software audits the medical record. When asked who checks and monitors the data pulled out by the system, there was no answer. On concurrent record review of the QAPI Report, does not indicate the software reviews patient care issues such as dealing with complaints or grievances. A review of the agency's QAPI/PIP indicated that the governing body only had 1 PI meeting dated 1/4/2024 signed by the Chief Executive Officer and two Administrators had only one Performance Improvement (PI) meeting discussion minutes included new business/ policies and procedures review update and: • Team discussed patient satisfaction rates from the fourth quarter. • Team discussed and approved risk-based fall prevention interventions. • Fall prevention measures and goals discussed. • Team will continue to monitor fall risk and goals. • Team discussed infection control plan. • Team discussed continuous measures to prevent infections. • Team discussed hand hygiene measures and discussed the importance of monitoring compliance rates using opportunity vs occurrence. • Team discussed perception of care audits from the fourth quarter · Flu policy and procedures were reviewed and approved. · Culture of Safety Audits were completed for the fourth quarter. There was no documented evidence that the governing body discussed complaints and grievances. The agency's policy and procedure titled "Quality Assessment and Performance Improvement Plan" indicated QAPI Committee the administrator, the director of nursing, infection control and prevention officer, medical director, therapists and chosen field staff members will provide QAPI leadership by being on the QAPI committee. The general staff members will be chosen from staff that have direct care and/or service responsibilities, including nurses. CHHAs, and therapists. The general staff will serve a one year commitment and the positions will be rotated among staff to ensure as many persons as possible have the opportunity to serve on the committee . The QAPI committee will meet quarterly. QAPI activities and outcomes will be on the agenda of every staff meeting. The minutes from all meetings will be available online. The QAPI committee will report all activities to the governing board. The QAPI committee will have responsibility for reviewing data. suggestions. and input from patients, stair. family members. and other stakeholders. The QAPI committee will prioritize opportunities for improvement and determine which performance improvement projects will be initiated. When an issue or problem is identified that is not systemic and does not require a performance improvement project. the QAPI committee will decide how to correct the issue or problem. These corrections may include on each decision, corrective action plan or rapid improvement cycle. The committee will solicit individuals from the organization to participate in performance improvement projects. The committee will monitor progress provide input, and ensure the individuals involved in the project have the resources they need. The PIP teams will consider each PIP a learning process. The team will follow steps and processes that are needed for any quality improvement project. The responsibilities for the PIP teams will be to determine what information is needed for the PIP and how to obtain the information. They will determine a timeline based on the PIP The QAPI committee will respond in timely manner to assure momentum is maintained. The team will develop on action pion using the organizations usual format. Interventions that will make change will be implemented by the team. The team will use root cause analysis to ensure that the root cause and contributing factors are identified When determining and implementing interventions, PDSA cycles will be used. The team will select and/or create measurement tools to ensure that the changes they are implementing ore having the desired effect. To prevent future events and promote sustained improvement our organization develops actions to address the identified root cause and/or contributing factors of on issue/event that will affect change at the systems level. We use Plan-Do-Study-Act cycles to test actions and recognize and address "unintended" consequences of planned changes. To ensure the planned changes/interventions are implemented and effective in making and sustaining improvements, our organization chooses indicators/measures that tie directly to the new action and conducts ongoing periodic measurement and review to ensure that the new action has been adopted and is performed consistently. The number and scope of performance improvement projects are based on the patients' needs and internal organization needs. The QAA committee will review data and input on a monthly basis to look for potential topics for PIPS. We will monitor and analyze data, and review feedback and input from patients, staff, and Q/\PI results. We will look at issues, concerns, and areas that need improvement as well as areas that will improve the quality of core and services for our patients. Factors we will consider high-risk, high-volume, or problem-prone areas that affect health outcomes, quality of core and services, and areas that affect staff.

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 observation and record review, the home health agency (HHA) failed to address the increasing number of complaints or grievances in their governing body meetings. This deficient practice had the potential in the delay of required necessary services, intervention, and treatment identified in the plan of care. A complaint validation survey was conducted at this agency location from 4/2/2024 to 4/8/2024. The agency active census was two thousand five hundred sixty-eight (2568) patients. A request was made on 4/2/2024, at 11 a.m., to the Administrator Designee for the performance improvement projects (PIP) derived from the data collected from the Quality Assurance and Performance Improvement (QAPI, the coordinated application of two mutually‑reinforcing aspects of a quality management system. QAPI takes a systematic, comprehensive, and data‑driven approach to maintaining and improving safety and quality in nursing homes while involving all nursing home caregivers in practical and creative problem solving) program, complaint /grievance log and governing body minutes during the entrance conference. During a review of the HHA's document titled " Governing Body Minutes" indicated the agency conducted only 2 governing body meetings. One governing body meeting dated 4/1/2024 indicated the agency met for the appointment of a new Director of Home Health Clinical Operations. On 3/13/2024 another meeting was held to discuss all programs approved, Human resources, Administrative, clinical and Covid-19 policies and procedures. There was no discussion that the agency addressed their increasing complaints/grievances. A review of the HHA's document titled " QAPI Plan" reviewed last 3/13/2024, indicated that QAPI Program Quality Assurance and Performance Improvement (QAPI) is a data driven and proactive approach to quality improvement. All members of the organization, including patients and families, are involved in continuously identifying opportunities for improvement. Gaps in systems ore addressed through planned interventions with a goal of improving the overall quality of life and quality of core and services delivered to home health patients. The QAPI program is an outcome-based performance improvement model, which assesses and measures the quality of the overall home health program The QAPI program will use contributions from all agency departments and committees who are involved in the provision or monitoring of care/services to patients and patient's families. The program goals and objectives are to systematically monitor, analyze and improve safety and quality outcomes of quality indicators and adverse patient events. The agency will develop, implement. evaluate and maintain an effective, ongoing, agency wide, data-driven QAPI program. The Governing Body must ensure that the program reflects the complexity of its organization and services (including contracted services}, focus on indicators related to improved outcomes including the use of emergent care services, hospital admissions and re-admissions and tokes actions that address the agency performance across the spectrum of care. The Governing body will approve the indicators and frequency of data collection. The agency will maintain documentation of the QAPI program.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the nursing staff failed to perform infection control precaution while providing wound care treatment for one of 18 sampled patients (Patient 1). This deficient practice has the potential to result in the transmission and spread of infection. Findings: During a review of Patient 1's Patient Information sheet indicated a start of care date (SOC) of 12/7/2023, with a diagnosis of unspecified open wound to the left foot. During a review of Patient 1’s Home Health Certification and Plan of Care (document used to establish the patient's treatment plan for the initial certification period and any continued sixty-day recertification periods) for the certification period from 2/05/2024 to 4/04/2024, included an order for the skilled nurse (SN) to visit the patient every day to perform assessment and observation of each body system, and to perform wound care on left foot and right foot wound. On 4/3/2024 at 9 a.m., a home visit was conducted at Patient 1’s residence with a registered nurse (RN 1). Patient 1 was observed awake, alert, oriented x 3 (to person, place, and time), and ambulatory. On concurrent observation of RN 1 during the home visit, RN 1 performed hand hygiene with soap and water, donned a new pair of gloves, and took a white plastic container full of wound care supplies from a table and placed it on floor next to the patient without placing any protective barrier. During an interview with RN 1 after the home visit, on 4/3/2024 at 9:40 a.m., RN 1 stated that she should have put a pad on the floor before placing the container with wound care supplies to prevent cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect). During an interview, on 4/06/2024 at 1 p.m., with the Administrator/Director of Patient Care Services (ADM/DPCS), the ADM/DPCS stated agency staff should always follow infection prevention measures and acknowledged that any equipment and supplies touching the floor is an infection control issue. During a review of the agency’s policy and procedure titled “Infection Control Plan,” revised November 2022, indicated; "Tarlani Healthcare is committed to reducing the risk of acquisition and transmission of healthcare associated infections (HAIs). Recognized prevention and control mechanisms will be implemented for planning, surveillance, identification, prevention/controls, and reporting procedures."

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 observation, interview, and record review, the home health agency (HHA) failed to meet the Condition of Participation for Clinical Record as follows: The home health agency staff failed to submit nursing clinical notes within the timeframe as indicated in the agency's policy and procedure for one of 18 sampled patients (Patient 3). (Refer to G1012) The home health agency failed to maintain and document accurate information in the electronic medical record for one of 18 sampled patients (Patient 8) when Patient 8’s primary emergency contact and phone number for primary physician were not accurate. (Refer to G1018) The Home Health Agency failed to ensure patients' clinical records were completed, signed, and dated for eighteen of 18 sampled patients (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18). (Refer to G1024) The cumulative effect of this systemic practice resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal regulations for Clinical Record to ensure the highest quality of care are being provided to patients certified to receive home health services.

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) staff failed to submit nursing clinical notes within the timeframe as indicated in the agency's policy and procedure for one of 18 sampled patients (Patient 3). This deficient practice had the potential for the healthcare providers not to have the most current patient care services and health assessment. During a review of Patient 3's Patient Information sheet indicated a start of care date (SOC) of 2/29/2024, with a diagnosis of hemiplegia (paralysis of one side of the body) following a cerebral infarction (also known as a stroke, refers to damage to tissues in the brain due to a loss of oxygen to the area). During a review of Patient 3’s Home Health Certification and Plan of Care (document used to establish the patient's treatment plan for the initial certification period and any continued sixty-day recertification periods) for the certification period from 2/29/2024 to 4/28/2024, included an order for the skilled nurse (SN) to visit the patient two times a week for 5 weeks, and then once a week for 4 weeks to perform assessment and observation of each body system, assess pain level and effectiveness of pain medications, and to teach patient/patient caregiver on medication management, current medications’ actions/potential adverse reactions (unwanted undesirable effects) and compliance. On 4/5/2024, during a review of Patient 3’s SN Visit calendar indicated that there was a patient visit conducted on 3/28/2024. However, there was no documented evidence in the patient’s electronic charting that the SN submitted her visit notes. During a concurrent interview and joint record review, on 4/06/2024 at 1:00 p.m., with the Administrator/Director of Nursing Services (ADM/DPCS), ADM/DPCS stated and confirmed the nurse had not submitted her visit notes on 3/28/2024. ADM/DPCS stated field nurses should submit their visit notes every Wednesday after the visit and acknowledged that there was a delay in the submission of visit note by the skilled nurse for Patient 3. During a review of the agency’s policy and procedure titled, “Entries into the Clinical Record”, revised April 2017, 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. All documentation will be turned in to the office by latest Wednesday following the week of the actual visit date and clinical notes dictated or written will be incorporated into the patient’s heath record by latest Wednesday following the week of the actual visit date.

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 observation, interview and record review, the home health agency failed to maintain and document accurate information in the electronic medical record for one of 18 sampled patients (Patient 8). This deficient practice had the potential for the delay in communication and implementation of the patient’s plan of care. A review of Patient 's “Patient Profile Information” indicated, a start of care (SOC) date of 1/5/2024, with a certification period of 3/5/2024 to 5/3/2024. Patient 8's diagnosis included unspecified wound in the abdominal wall. During a phone call attempt on 4/5/2024 at 4:09 p.m., to interview Patient 8’s primary care physician, the voice prompt heard was “You have reached Kaiser Permanente’s non-working number.” During a phone call attempt on 4/5/2024 at 6:58 p.m., to speak with Patient 8’s family member during the validation survey, Unidentified person 1 (UP 1) answered the call. UP 1 stated he is not related to Patient 8 in blood or consanguinity. UP 1 refused to state his name, stated he had been receiving multiple voice messages and phone calls from this home health agency and every time he told them to remove his name in contact list for this patient. UP 1 stated that he spoke to multiple people in the agency begging them to remove his name. During an interview with the Project Manager 1 (PM 1) for Call Center Operations on 4/5/2024 at 11:05 a.m., stated that when referrals were established, any other information that are required for the patients' chart were verified at the call center. PM 1 stated that she would refer to the clinical managers for any clinical questions before it is entered in the patient’s record. On 4/8/2024 at 12:30 p.m., during a joint interview with the Administrator designee (AD) and the project manager 2 (PM2) for maintenance processes of the electronic medical record, AD stated they both work together to improve digital processing and upgrades in their electronic medical record. Per AD stated that they follow up regularly with Kaiser and conducts daily check making sure that orders and information provided are all there. A review of the HHA’s policy titled “Entries in the Clinical Record” revised 4/2017, indicated Home health personnel providing direct patient care and supervisory functions have authority to make entries into the clinicaI 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. Note: Times means actual time that an event occurred, which is not necessarily the time when the documentation was entered into the record. The date and time requirement applies to all entries in the record and the medical record should accurately reflect a clear account of the patient's entire course of care. The clinical record should tell a linear story of the course of the patient's care that is managed and delivered by the organization.

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 patients' clinical records were completed, signed, and dated for 11 of 18 sampled patients (Patients 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11). The deficient practice resulted in incomplete patients' clinical records. f. During a review of Patient 6's Patient Information sheet indicated an SOC of 3/19/2024, with a certification period of 3/19/2024 to 5/17/2024. Patient 6's diagnosis included type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar) with hemodialysis (a procedure where a dialysis machine and a special filter called an artificial kidney, or a dialyzer, are used to clean your blood) with left foot amputation (the removal of a leg, foot or toes from the body) During a review of Patient 6’s Home Health Certification and Plan of Care for the certification period from 3/19/2024 to 5/17/2024, included an order for the skilled nurse (SN) to visit the patient every day to perform assessment and observation of each body system, and to perform wound care on left foot and right foot wound. Further review of the POC indicated that the area for the physician signature was blank. g. During a review of Patient 7’s Patient Information sheet indicated a SOC date of 10/24/2023, with diagnosis of type 2 diabetes and wound care. During a review of Patient 7’s Home Health Certification and Plan of Care for the certification period from 10/24/2023 to 12/22/2023, included an order for the skilled nurse to visit the patient three times a week for 9 weeks to perform assessment and observation of each body system, medication compliance, and wound care management. Further review of the POC indicated that the area for the physician signature was blank and was in draft form. For the certification period of 2/21/2024 to 4/20/2024 review of the POC indicated that the area for the physician signature was blank. h. During a record review of Patient 8's Patient Information sheet indicated a SOC date of 1/5/2024 with a diagnosis including unspecified wound of the abdominal wall During a review of Patient 8s Home Health Certification and Plan of Care for the certification period from 1/5/2024 to 3/4/2024 and 3/5/2024 to 5/5/2024, included an order for the skilled nurse (SN) to visit the patient two times a week for 9 weeks to perform assessment and observation of each body system, medication compliance, and instruct patient/patient caregiver on infection control/pressure relief measures and skin care. Further review of the POC indicated that the area for the physician signature was blank. i. During a closed record review of Patient 9's Patient Information sheet indicated a SOC date of 8/5/2023, with a diagnosis including type 2 diabetes with dialysis. During a review of Patient 9’s Home Health Certification and Plan of Care for the certification period from 8/5/2023 to 10/3/2023 and 12/3/2023 to 1/31/2024, included an order for the skilled nurse (SN) to visit the patient two times a week for 9 weeks to perform assessment and observation of each body system, medication compliance, and instruct patient/patient caregiver on infection control/pressure relief measures and skin care. Further review of the POC indicated that the area for the physician signature was both blank. j. During a closed record review of Patient 10's Patient Information sheet indicated an SOC date of 7/6/2023, with a diagnosis including chronic pain. During a review of Patient 10’s Home Health Certification and Plan of Care for the certification period from 7/6/2023 to 9/3/2023, included an order for the skilled nurse (SN) to visit for evaluation and discharge visits only to perform assessment and observation of each body system, medication compliance, and instruct patient/patient caregiver on infection control/pressure relief measures and skin care. Further review of the POC indicated that the area for the physician signature was blank. k. During a closed record review of Patient 11's Patient Information Sheet indicated an SOC date of 5/31/2023 with the diagnosis of ulcer of the anus and rectum (a break in the skin or mucous membrane along with loss of tissue at the surface. Ulcers can occur on and within the body, including along the lining of the colon and rectum, and on the anus). During a review of Patient 11’s Home Health Certification and Plan of Care for the certification period from 5/31/2023 to 7/29/2023, included an order for the skilled nurse (SN) to visit for twice a week for one week and once a week for two weeks to perform assessment and observation of each body system, medication compliance, and instruct patient/patient caregiver on infection control/pressure relief measures and skin care. Further review of the POC indicated that the area for the physician signature was blank. During a concurrent record review and interview with the Administrator/Director of Patient Care Services (ADM/DPCS), 4/8/2024 at 1:10 p.m., she stated the plan of care and other patient records should all be signed and dated. During a joint interview on 4/8/2024 at 12:30 p.m., with the Administrator Designee (ADD) and project Manager for Medical Records (PM) stated they work together to improve the digital processing of the electronic medical record (EMR- are a digital version of the paper charts in the clinician's office) and upgrades. ADD further stated they have 30 days to upload the POC in the EMR. Per PM stated that the POC is faxed out to the physician for signature via their program. Per ADD, her team follows up with the physician's regularly, leaves them messages in their call center. Per ADD , stated that "our daily check is making sure that the orders and other forms are signed and uploaded in the EMR. A review of the HHA's document titled " Entries in the Clinical Record" revised April 2017 indicated Home health personnel providing direct patient care and supervisory functions have authority to make entries into the clinicaI 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. Note: Times means actual t me that an event occurred, which is not necessarily the time when the documentation was entered into the record. The date and time requirement applies to all entries in the record and the medical record should accurately reflect a clear account of the patient's entire course of ca e. The clinical record should tell a linear story of the course of the patient's care that is managed and delivered by the organization. Based on the findings of the reassessment, additional orders will be generated and forwarded to the physician ( or other authorized licensed independent practitioner) for signature(s). Findings: a. During a review of Patient 1's Patient Information sheet indicated a start of care date (SOC) of 12/7/2023, with a diagnosis of unspecified open wound, left foot. During a review of Patient 1’s Home Health Certification and Plan of Care (POC, document used to establish the patient's treatment plan for the initial certification period and any continued sixty-day recertification periods) for the certification period from 2/05/2024 to 4/04/2024, included an order for the skilled nurse (SN) to visit the patient every day to perform assessment and observation of each body system, and to perform wound care on left foot and right foot wound. Further review of the POC indicated that the area for the physician signature was blank. b. During a review of Patient 2’s Patient Information sheet indicated a SOC date of 12/12/2023, with diagnosis of other chronic pain. During a review of Patient 2’s Home Health Certification and Plan of Care for the certification period from 2/10/2024 to 4/09/2024, included an order for the skilled nurse to visit the patient three times a week for 9 weeks to perform assessment and observation of each body system, medication compliance, and wound care management. Further review of the POC indicated that the area for the physician signature was blank. c. During a review of Patient 3's Patient Information sheet indicated a SOC date of 2/29/2024, with a diagnosis of hemiplegia (paralysis of one side of the body) following a cerebral infarction (also known as a stroke, refers to damage to tissues in the brain due to a loss of oxygen to the area). During a review of Patient 3’s Home Health Certification and Plan of Care for the certification period from 2/29/2024 to 4/28/2024, included an order for the skilled nurse (SN) to visit the patient two times a week for 5 weeks, and then once a week for 4 weeks to perform assessment and observation of each body system, assess pain level and effectiveness of pain medications, and to teach patient/patient caregiver on medication management, current medications’ actions/potential adverse reactions (unwanted undesirable effects) and compliance. Further review of the POC indicated that the area for the physician signature was blank. d. During a review of Patient 4's Patient Information sheet indicated a SOC date of 3/03/2024, with a diagnosis including type 2 diabetes mellitus (a condition that results in too much sugar circulating in the bloodstream), essential hypertension (high blood pressure), and chronic obstructive pulmonary disease (COPD-a group of lung diseases that block airflow and make it difficult to breathe). During a review of Patient 4’s Home Health Certification and Plan of Care for the certification period from 3/03/2024 to 5/01/2024, indicated that the area for the physician signature was blank. e. During a closed record review of Patient 5's Patient Information sheet indicated a SOC date of 11/08/2023, with a diagnosis including essential hypertension, venous insufficiency (improper functioning of the leg veins [blood vessels that carry oxygen-poor blood to your heart] causing swelling and skin changes), and history of falling. During a review of Patient 5’s Home Health Certification and Plan of Care for the certification period from 1/07/2024 to 3/06/2024, included an order for the skilled nurse (SN) to visit the patient two times a week for 9 weeks to perform assessment and observation of each body system, medication compliance, and instruct patient/patient caregiver on infection control/pressure relief measures and skin care. Further review of the POC indicated that the area for the physician signature was blank. During a concurrent record review and interview with the Administrator/Director of Patient Care Services (ADM/DPCS), 4/8/2024 at 1:10 p.m., she stated the plan of care and other patient records should all be signed and dated. During a review of the agency’s policy and procedure titled, “Entries into the Clinical Record”, revised April 2017, 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. Signature authorization of clinical documentation will include the staff member’s name and credentials (as specified on professional licenses and/or certification documents). n. During a review of Patient 12's Patient Information sheet indicated an SOC of 3/19/2024, with a certification period of 3/19/2024 to 5/17/2024. Patient 6's diagnosis included type 2 diabetes (is a chronic condition where the body does not produce insulin which regulates the blood sugar) with hemodialysis (a procedure where a dialysis machine and a special filter called an artificial kidney, or a dialyzer, are used to clean your blood) with left foot amputation (the removal of a leg, foot or toes from the body) During a review of Patient 12’s Home Health Certification and Plan of Care for the certification period from 3/19/2024 to 5/17/2024, included an order for the skilled nurse (SN) to visit the patient every day to perform assessment and observation of each body system, and to perform wound care on left foot and right foot wound. Further review of the POC indicated that the area for the physician signature was blank. o. During a review of Patient 13’s Patient Information sheet indicated a SOC date of 2/5/2024, with diagnosis of non-pressure chronic ulcer other part, and type 2 diabetes and wound care. During a review of Patient 13’s Home Health Certification and Plan of Care for the certification period from 2/5/2024 to 4/0/2024, included an order for the skilled nurse to visit the patient four times a week for 1 week, three times a week for 7 weeks and two times a week for 1 week to perform assessment and observation of each body system, medication compliance, and wound care management. Further review of the POC indicated that the area for the physician signature for the certification period of 2/5/2024 to 4/4/2024 was blank.. p. During a review of Patient 14's Patient Information sheet indicated a SOC date of 1/3/2024, with a diagnosis diabetes Mellitus 2 (a group of diseases that results in too much sugar in the blood) and chronic Obstructive Pulmunary Disease ( a group of lung diseases that block air flow and make it difficult to breathe) ( During a review of Patient 14’s Home Health Certification and Plan of Care for the certification period from 3/3/2024 to 5/1/2024, included an order for the skilled nurse (SN) to visit the patient one time a week for 9 weeks, to perform assessment vital signs, auscultate lung sounds for any abnormalities, oxygen saturation via pulse oximeter every visit and check blood sugar levels using aseptic technique assessing monitor signs and symptoms of COPD exacerbations medication reconciliation every visit. Further review of the POC indicated that the area for the physician signature was blank. There were also no Skilled nursing noes in patient 14's electronic record. q. During a review of Patient 15's Patient Information sheet indicated a SOC date of 11/16/2023, with a diagnosis including encounter for attention to gastrostomy tube, a medical device inserted in the abdomen for people who cannot obtain nutrition by mouth are unable to swallow safely or need nutritional supplementation, dysphasia (difficulty swallowing), and malignant neoplasm of tonsil( a lymph node in the back of the mouth and top of the throat that helps filter out bacteria and other germs to prevent infection in the body-Cancer of tonsil.) During a review of Patient 15’s Home Health Certification and Plan of Care for the certification period from 3/15/2024 to 5/01\\13/2024, indicated that the area for the physician signature was blank. r. During a closed record review of Patient 16's Patient Information sheet indicated a SOC date of 12/3/2023 with a diagnosis including other chronic pain and unsteadiness on feet period During a review of Patient 16s Home Health Certification and Plan of Care for the certification period from 2/11/2024 to 4/10/2024 , included an order for the skilled nurse (SN) to visit the patient four times a week for 1 weeks, two times a week for 1 week, and one visit for 1 week to to perform assessment and observation of each body system, medication compliance, and instruct patient/patient caregiver on 911 protocol, signs/symptoms of heart attack and actions to take. Further review of the POC indicated that the area for the physician signature was blank. s. During a closed record review of Patient 17's Patient Information sheet indicated a SOC date of 12/30/2023, with a diagnosis including hypertensive heart and chronic kidney disease with heart failure(thee hearts inability to pump enough blood to other parts and the kidney leading to kidney failure and heart failure .) CKD During a review of Patient 17’s Home Health Certification and Plan of Care for the certification period from 12/30/2023 to 2/27/2024 , included an order for the skilled nurse (SN) to visit the patient one time a week for 1 week, two times a week for 4 weeks and one time a week for 4 weeks to perform vital signs, ask you take lung sounds for abnormalities, check pain location intensity and severity of pain implement pain relief measures any valuate medications. The physician also instructed physical therapy to evaluate and set up treatment plans. Further review of the POC indicated that the area for the physician signature was both blank. t.. During a closed record review of Patient 18's Patient Information sheet indicated an SOC date of 7/6/2023, with a diagnosis including malignant neoplasm of sigmoid( cancer of the large intestine closet to the rectum). During a review of Patient 10’s Home Health Certification and Plan of Care for the certification period from 11/28/2023 to 1/27/2024, included an order for the Physical Therapist to visit for 7 weeks to evaluation assessment to determine patients conditions and physical therapy needs provision of therapeutic slash strength training exercises, balance, coordination training mobility and range of motion exercises gait transfer/training and home safety. Skilled nurse visits evaluation and discharge visit only if applicable. Further review of the POC indicated that the area for the physician signature was blank. During a concurrent record review and interview with the Administrator/Director of Patient Care Services (ADM/DPCS), 4/8/2024 at 1:10 p.m., she stated the plan of care and other patient records should all be signed and dated. During a joint interview on 4/8/2024 at 12:30 p.m., with the Administrator Designee (ADD) and project Manager for Medical Records (PM) stated they work together to improve the digital processing of the electronic medical record (EMR- are a digital version of the paper charts in the clinician's office) and upgrades. ADD further stated they have 30 days to upload the POC in the EMR. Per PM stated that the POC is faxed out to the physician for signature via their program. Per ADD, her team follows up with the physician's regularly, leaves them messages in their call center. Per ADD , stated that "our daily check is making sure that the orders and other forms are signed and uploaded in the EMR. A review of the HHA's document titled " Entries in the Clinical Record" revised April 2017 indicated Home health personnel providing direct patient care and supervisory functions have authority to make entries into the clinicaI 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. Note: Times means actual t me that an event occurred, which is not necessarily the time when the documentation was entered into the record. The date and time requirement applies to all entries in the record and the medical record should accurately reflect a clear account of the patient's entire course of ca e. The clinical record should tell a linear story of the course of the patient's care that is managed and delivered by the organization. Based on the findings of the reassessment, additional orders will be generated and forwarded to the physician ( or other authorized licensed independent practitioner) for signature(s).