Every finding on record at Erg Home Health Providers, Inc

The following reflects the findings of the California Department of Public Health during a Recertification Survey at the new agency address at 550 North Brand Blvd., Suite 1030, Glendale, CA 91203. Old Address: 11700 South Street Suite 200, Artesia, CA 90701 Previous Address: 500 North Central Avenue Suite 440 Glendale, CA 91203 Unapproved New Address: 550 North Brand Blvd., Suite 1030, Glendale, CA 91203 Representing the California Department of Public Health: Surveyor ID # 44802, Health Facilities Evaluator Nurse Surveyor ID # 36459, Health Facilities Evaluator Nurse Surveyor ID # 44290, Health Facilities Evaluator Nurse Census: 53 Unduplicated admissions: 53 Sample Size: 9 Home Visits: 3 Closed Record review: 2 On 6/8/2023 at 5:54 pm, an Immediate Jeopardy (IJ- a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) was called in the presence of the agency’s Administrator (ADM) and ADM designee for the agency’s failure to ensure: 1. For Patient 1, the agency did not follow the patient plan of care (POC) to notify the physician of systolic blood pressure (BP) greater than 160 or less than 90 and diastolic blood pressure greater than 90 or less than 60. During a joint home visit with agency’s LVN 1 on 6/7/23, it was observed LVN 1 checked Patient 1's blood pressure and the BP result was 88/44. LVN 1 did not recheck BP, did not notify the physician, and did not report to the agency’s Director of Nursing Services (DPCS) or agency’s Administrator for further instructions. On the same day, 6/7/23, the surveyor and LVN 1 returned to the agency. A review of the skilled nurse’s notes dated 6/7/23 indicated LVN 1 documented Patient 1’s blood pressure as 110/90. However, the history of the blood pressure monitor indicated the patient’s blood pressure was 88/44. 2. The agency did not have DPCS, DPCS designee since 2/14/23, to assume the responsibility for clinical nursing needs. There was one Registered Nurse that was currently on vacation and the agency did not have an RN to conduct the comprehensive nursing assessments. 3. The agency has a census of 53 active patients. On 6/10/23 at 12:18 pm, the agency submitted an acceptable IJ removal plan that included the following: 1. Counseling and disciplinary action of LVN 1. 2. In-service of the agency’s nursing staff on home visit and clinical documentation that included to verify significant changes in vital signs for accuracy, to document any change to patient condition or vital signs and report to physician, case manager, supervisor, administrator on record, ask and investigate if medications adversely affected blood pressure and heart rate, and to verify patient’s overall condition is stable and vital signs are within normal limits. 3. Appointment of a Director of Patient Care Services (DPCS). On 6/10/23 at 3:11pm, in the presence of the ADM, the Survey Team removed the IJ after verifying and confirming onsite that the agency implemented the IJ removal plan of correction. The following Conditions of Participation (COP) were not met: 484.55 Condition of Participation: Comprehensive Assessment of Patients 484.60 Condition of Participation: Care Planning, Coordination of Services, and Quality of Care 484.100 Condition of Participation: Comply with all Federal/State/Local Laws 484.110 Condition of Participation: Clinical Records

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on interview, and record review the facility failed to ensure the Outcome and Assessment Information Set (OASIS) transmitted to the Centers for Medicare & Medicaid Services (CMS) were accurate and reflected the status of the patients at the time of the assessment, for two of nine sample patients (Patients 2 and 3). This failure had the potential to result in an inconsistent assessment of the patient's status transmitted to CMS that could lead to inaccurate care and payment or disbursements of services provided to the patients. Findings: a. A review of Patient 2's clinical record indicated a Start of Care (SOC) date of 12/16/2019, with a diagnosis of hypertensive heart disease (heart problems that occur because of high blood pressure that is present over a long time) without heart failure. A review of Patient 2 's Plan of Care (POC) for certification period 03/30/2023 to 5/28/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for eight weeks. The POC further identified the patient was on homebound status. A review of Patient 2’s OASIS (Outcome and Assessment Information Set, a patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality) dated 03/29/2023, indicated that on the section health screening under homebound it indicated yes. The OASIS further indicated that criteria one for homebound status was marked off and indicated that patient is confined because of illness, needs the aid of supportive devices such as crutches, canes, wheelchairs and walkers; the use of special transportation; or the assistance of another person in order to leave their place of residence and/or patient has a condition such that leaving his or her home is medically contraindicated. Further review of the OASIS indicated there was no signature from the nurse who completed the assessment. During an interview with Patient 1, on 06/07/2023, at 11:58 a.m., he stated that if family member is not available to take him to his doctor’s appointment then he takes the bus to the doctor’s office. b. A review of Patient 3's clinical record indicated a Start of Care (SOC) date of 12/16/2019, with a diagnosis of type 2 diabetes mellitus (chronic condition that affects the way the body processes blood sugar). A review of Patient 3 's Plan of Care (POC) for certification period 05/29/2023 to 07/27/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for eight weeks. The POC further indicated that on the section regarding homebound status it indicated yes. A review of Patient 3’s OASIS dated 05/28/2023, indicated that on the section health screening under homebound it indicated yes. The OASIS further indicated that criteria one for homebound status was marked off and indicated that patient is confined because of illness, needs the aid of supportive devices such as crutches, canes, wheelchairs and walkers; the use of special transportation; or the assistance of another person in order to leave their place of residence and/or patient has a condition such that leaving his or her home is medically contraindicated. Further review of the OASIS indicated that there was no signature from the nurse who completed the assessment. During an interview with Patient 3, on 06/07/2023 at 12:25 p.m., he stated that he takes the bus with Patient 1 to the doctor’s office. During a concurrent record review and interview with Registered Nurse (RN 1) on 06/09/2023, at 1:16 p.m., she stated that she did not see Patient 3 on 05/28/2023 and that she was out of the country. RN 1 stated that she was not sure why the OASIS dated 05/28/2023 had her name, because she did not do the visit and she did not create the OASIS. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 06/10/2023, at 1:28 p.m., and 1:37 p.m., she stated homebound means the patient does not go out because they are ill and if the patient takes the bus, then they are not homebound. DPCS further stated the OASIS should be signed by the nurse performing the assessment. A review of agency’s policy and procedure titled, “OASIS Data Transmission” dated 10/2011, indicated that the encoded OASIS data must be accurately reflect the patient’s status at the time of assessment. The policy and procedure further indicated that the organization must electronically transmit accurate, complete and encoded OASIS data for each patient to the State agency or CMS OASIS contractor at least monthly.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Comprehensive Assessment of Patients as follows: 1. The HHA failed to ensure the comprehensive assessment was accurate and completed for two of nine patients (Patient 1 and Patient 8). Refer to G520. 2. The HHA failed to ensure the homebound status of two of nine sample patients (Patient 2 and Patient 3). Refer to G522. 3. The HHA failed to maintain a current medication profile for three of nine sampled patients (Patient 1, 2, and 3). Refer to G536. The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver mandated compliance with Federal regulations for Comprehensive Assessment of Patients to ensure highest quality healthcare is provided to patients assessed to receive home health services. .

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the HHA failed to ensure the comprehensive assessment was accurate and completed within five days from Start of Care (SOC) for two of nine patients (Patient 1 and Patient 8). This deficient practice had the potential to result in the patient’s needs not being identified and assessed, leading to poor quality nursing care needed to maintain the patient’s quality of life and well-being. Findings: a. A review of Patient 1's Patient Information Sheet indicated a Start of Care (SOC) on 5/1/2023, with primary diagnosis of malignant neoplasm (cancerous tumor) of the brain, unspecified and a secondary diagnosis of type 2 diabetes mellitus (DM, a chronic condition that affects the way the body processes blood sugar) with diabetic nephropathy (the deterioration of kidney function). A review of Patient 1’s Comprehensive Assessment/OASIS (Outcome and Assessment Information Set, a patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality) dated 5/2/2023 indicated it was not signed by the registered nurse who performed the assessment. The assessment indicated that Patient 1 had a diagnosis of type 2 DM, however indicated on the Endocrine section that Patient 1 was within normal limits (WNL), that patient was not a diabetic and that the questions pertaining to insulin and glucometer (machine used to check blood sugar) use were left blank. On 6/7/23, at 11:00 am, a joint home visit was conducted with Licensed Vocational Nurse (LVN 1) at Patient 1’s home residence. Patient 1 was observed lying in bed, alert and oriented, with electrodes (a device such as a small metal plate or needle that carries electricity from an instrument to a patient for treatment or surgery) on her head covered by a white net wrap. Caregiver (CG 1) translated for Patient 1 in her primary language and stated that Patient 1 was currently involved in a six-month study on her brain. LVN 1 took Patient 1’s vitals and Patient 1’s medications were checked. CG 1 stated that Patient 1 started taking Januvia (medication to help treat type 2 diabetes) and stopped taking insulin (medication used to help the body use or store the blood glucose [blood sugar] it gets from food) about two weeks ago. b. A review of Patient 8's Patient Information Sheet indicated a Start of Care (SOC) on 9/9/2022, with primary diagnosis of sepsis (a serious condition in which the body responds improperly to an infection) and a secondary diagnosis of renal (related to kidney) and perinephric (around the kidney) abscess (a collection of pus that occurs due to a bacterial infection). A review of Patient 8’s Comprehensive Assessment/OASIS dated 9/9/20223 indicated it was not signed by the registered nurse who performed the assessment. During an interview and record review on 6/10/2023, at 1:30 pm, the Director of Patient Care Services stated that Patient 1 and Patient 8 comprehensive assessment should be completed accurately and signed by the person performing the assessment. The current HHA’s policy for Comprehensive Assessments was requested, however was not provided. A review of the HHA’s policy, “Client Admission Process,” dated 6/27/1996 indicated that the admission professional will: a. Verify all the information on the Intake Form with the client/caregiver. b. Complete the Assessment for, including OASIS data elements, Plan of care/485, Care Plan, Medication regime review, and additional documents, as required. The data gathered shall form the basis for the Plan of Care and Care Plan.

Eligibility for Medicare home health benefit CFR(s): 484.55(b)(2) Except as provided in paragraph (b)(3) of this section, a registered nurse must complete the comprehensive assessment and for Medicare patients, determine eligibility for the Medicare home health benefit, including homebound status. This ELEMENT is not met as evidenced by: Based on interview and record review the home health agency (HHA) failed to ensure the homebound status of two of nine sample patients (Patient 2 and Patient 3) were clearly identified in the comprehensive assessment. The deficient practice had potential to admit patients who may not be eligible for Medicare home health benefits. Findings: a. A review of Patient 2's clinical record indicated a Start of Care (SOC) date of 12/16/2019, with a diagnosis of hypertensive heart disease (heart problems that occur because of high blood pressure that is present over a long time) without heart failure ( heart muscle doesn't pump blood as it should.) A review of Patient 2 's Plan of Care (POC) for certification period 03/30/2023 to 5/28/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for eight weeks. The POC further indicated that on the section regarding homebound status it indicated yes. A review of Patient 2’s OASIS (Outcome and Assessment Information Set, a patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality) dated 03/29/2023, indicated that on the section health screening under homebound it indicated yes. The OASIS further indicated that criteria one for homebound status was marked off and indicated that patient is confined because of illness, needs the aid of supportive devices such as crutches, canes, wheelchairs and walkers; the use of special transportation; or the assistance of another person in order to leave their place of residence and/or patient has a condition such that leaving his or her home is medically contraindicated (reason not to take a specific treatment). On 06/07/2023, at 11:30 a.m., a joint home visit with the Licensed Vocational Nurse (LVN 2) was conducted at Patient 2’s residence. During an interview with Patient 1, on 06/07/2023, at 11:58 a.m., he stated that if family member is not available to take him to his doctor’s appointment, then he takes the bus to the doctor’s office. b. A review of Patient 3's clinical record indicated a Start of Care (SOC) date of 12/16/2019, with a diagnosis of type 2 diabetes mellitus (chronic condition that affects the way the body processes blood sugar). A review of Patient 3 's Plan of Care (POC) for certification period 05/29/2023 to 07/27/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for eight weeks. The POC further indicated that on the section regarding homebound status it indicated yes. A review of Patient 3’s OASIS dated 05/28/2023, indicated that on the section health screening under homebound it indicated yes. The OASIS further indicated that criteria one for homebound status was marked off and indicated that patient is confined because of illness, needs the aid of supportive devices such as crutches, canes, wheelchairs and walkers; the use of special transportation; or the assistance of another person in order to leave their place of residence and/or patient has a condition such that leaving his or her home is medically contraindicated. On 06/07/2023, at 12:10 p.m., a joint home visit with the Licensed Vocational Nurse (LVN 2) was conducted at Patient 3’s residence. During an interview with Patient 3, on 06/07/2023, at 12:25 p.m., he stated that he takes the bus with Patient 1 to the doctor’s office. During a concurrent record review, and interview with the Director of Patient Care Services (DPCS), on 06/10/2023, at 1:37 p.m., DPCS stated that homebound means the patient does not go out because they are ill and if the patient takes the bus, then they are not homebound. A review of agency’s policy and procedure titled, “Client Admission Process” dated 06/26/1996, indicated that the purpose of the policy and procedure is to ensure that client identifying data is obtained and documented and clients are admitted for care according to the admission criteria.

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 maintain the current medication profiles for three of nine sampled patients (Patients 1, 2, and 3). This failure placed the patients at risk for medication errors and adverse drug reactions which can be life threatening. b. A review of Patient 2's clinical record indicated a Start of Care (SOC) date of 12/16/2019, with a diagnosis of hypertensive heart disease (heart problems that occur because of high blood pressure that is present over a long time) without heart failure. A review of Patient 2 's Plan of Care (POC) for certification period 03/30/2023 to 5/28/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for eight weeks. On 06/07/2023, at 11:30 a.m., a joint home visit with the Licensed Vocational Nurse (LVN 2) was conducted at Patient 2’s residence. A review of Patient 2’s Medication Profile, indicated that patient had an order for Celecoxib (used to relieve some symptoms caused by arthritis, such as inflammation, swelling, stiffness, and joint pain) 200 mg (milligram – unit of measurement) daily, Gabapentin (used with other medications to prevent and control seizures) 300 mg daily, Xarelto ( used to treat or prevent blood clots ) 20 mg daily, Meclizine HCL ( used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness) 25 mg every 12 hours, Clotrimazole Betamethasone (used to treat fungus infections) 0.05% topical daily, Restasis (used to treat chronic dry eye that may be caused by inflammation) 0.05% as needed daily and Diphenhist (used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms) 25 mg every 12 hours as needed. A review of Patient 2’s current medication indicated the patient takes Celecoxib 200 mg every 12 hours, Gabapentin 600 mg daily, Xarelto bottle did not have a prescription label on the bottle, Meclizine HCL 25 mg every 12 hours was not available. Further review of Patient 2’s current medication indicated that Clotrimazole Betamethasone 0.05% topical, Restasis 0.05% as needed daily and Diphenhist 25 mg every 12 hours as needed were discontinued and patient no longer takes them. Further review of Patient 2’s current medication also indicated that patient takes Loratadine (used to treat sneezing, runny nose, watery eyes, hives, skin rash, hay fever, itching, and other cold or allergy symptoms)10 mg tablet daily but it is not included in the medication profile. c. A review of Patient 3's clinical record indicated a Start of Care (SOC) date of 12/16/2019, with a diagnosis of type 2 diabetes mellitus (chronic condition that affects the way the body processes blood sugar). A review of Patient 3 's Plan of Care (POC) for certification period 05/29/2023 to 07/27/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for eight weeks. On 06/07/2023, at 12:10 p.m., a joint home visit with the Licensed Vocational Nurse (LVN 2) was conducted at Patient 3’s residence. A review of Patient 3’s Medication Profile, indicated that patient had an order for Tamsulosin HCL (used to treat the symptoms of an enlarged prostate) 1 gm (gram – unit of measurement) daily and Carvedilol (used to treat high blood pressure) 3.125 mg (miligram – unit of measurement). A review of Patient 3’s current medication indicated the patient takes Tamsulosin HCL 0.4 mg daily and Carvedilol 6.25 mg. Further review of Patient 3’s current medication also indicated that patient takes Olmesartan Medoxomil (used to treat high blood pressure) 40 mg tablet daily but it is not included in the medication profile. a. A review of Patient 1's Patient Information Sheet indicated a Start of Care (SOC) on 5/1/2023, with primary diagnosis of malignant neoplasm (cancerous tumor) of the brain, unspecified and a secondary diagnosis of type 2 diabetes mellitus (DM, a chronic condition that affects the way the body processes blood sugar) with diabetic nephropathy (the deterioration of kidney function). A review of Patient 1’s Plan of Care (POC) for certification period 5/2/2023 to 6/30/2023, included an order for a Skilled Nurse (SN) to visit once a week for eight weeks. The SN was to perform assessment of patient with malignant neoplasm of brain, unspecified, and type 2 DM. A review of Patient 1’s Medication Profile indicated for the following: -Insulin Aspart, Subcutaneous, 100 unit/milliliter (mL) 2-12 units sliding scale, subcutaneous, before meals (AC) for antidiabetics -Senna oral, 8.6 milligram (mg), one tab twice a day (b.i.d.) by mouth for constipation -Miralax oral, 17 grams/scoop, b.i.d. by mouth for laxatives -Apixaban (also known as Eliquis), 5 milligrams (mg) oral tablet, one tablet every 12 hours for 7 days for anticoagulant -Insulin, Glargine Subcutaneous, 100 units/mL, 0.16mL, 16 units, subcutaneous at bedtime for antidiabetics -Bactrim, oral, 400-80 mg, one tab, Monday, Wednesday and Friday On 6/7/23 at 11:00 am, a joint home visit was conducted with Licensed Vocational Nurse (LVN 1) at Patient 1’s home residence. Patient 1 was lying in bed, alert and oriented, with electrodes (a device such as a small metal plate or needle that carries electricity from an instrument to a patient for treatment or surgery) on her head covered by a white net wrape. Caregiver (CG 1) translated for Patient 1 in her primary language and stated that Patient 1 was currently involved in a six-month study on her brain. LVN 1 took Patient 1’s vitals and Patient 1’s medications were checked. CG 1 stated that Patient 1 used Voltaren gel (medication that relieves arthritis pain, improves mobility and reduces joint stiffness) for pain on her upper right leg, started taking Januvia and stopped taking insulin about two weeks ago. The following medications were observed with the LVN 1 and CG 1: -Elliquis, 5 mg, one tab by mouth twice a day -Pantoprazole, 40 mg, one tab by mouth everyday -Januvia, 100 mg, take one tab by mouth every day -Valsartan, 80 mg, one tab by mouth every day. During an interview on 6/7/2023 at 12:45 pm, Family Member (FM 1) stated Patient 1 no longer takes Bactrim or insulin and takes senna and Miralax only when needed, not every day. During an interview on 6/10/23 at 12:54 pm, the Director of Patient Care Services stated that the nurse should check the patient medications during each visit and that it was important to have an updated and accurate medication list to prevent medication errors for the patient’s safety. A review of the HHA’s policy titled, “Medication Profile,” dated 10/2011 indicated that patients receiving medication will have a current, accurate medication profile in the clinical record. The medication profile will be updated for each change to reflect current medications and new and/or discontinued medications. The policy indicated that the review will identify drug interactions, duplicative drug therapy, and noncompliance with drug therapy.

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 regarding Care Planning, Coordination, Quality of Care was met as follows: For Patient 1, the HHA failed to follow the patient’s Plan of Care (POC) for blood pressure parameters. This failure had the potential to result in a delay in care and hospitalization (Refer to G572) For Patients 1, Patient 2, Patient 3, Patient 4, and Patient 5, the HHA failed to ensure the patients' Plan of Care (POC) were reviewed, acknowledged, and signed by a physician. This failure had the potential to result in the physician not aware of the patient's health status and new treatment and medication orders. (Refer to G572). The HHA failed to develop and implement a Plan of Care (POC), that reflect patient's health status and services, for three of nine sampled patients (Patient 6, Patient 7 and Patient 9). This failure had the potential to result in patients not receiving the care needs and services to attain or maintain the patient health status and well-being. (Refer to G580). The HHA failed to notify the physician of a condition change for two of nine sampled patients (Patient 1 and Patient 8). This deficient practice resulted in the physician not aware of the patients change in condition. (Refer to G602). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure highest quality health care is provided to patients assessed to receive home health services. .

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 observation, interview, and record review, the home health agency (HHA) failed to provide care and services in accordance with the plan of care for 5 of 9 patients (Patients 1, 2, 3, 4, and 5) by failing to: 1. Ensure the physician was notified promptly when Patient 1's blood pressure reading was out of parameters. This failure had the potential to result in Patient 1's experiencing complications from low blood pressure, that included dizziness or light headedness, falls, shortness of breath, and chest pain, and requiring further intervention and hospitalization. 2. Ensure Plans of Care (POC) were signed and dated by the physician within 30 days of start of care for Patients 1, 2, 3, 4, and 5, 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. Findings: b. A review of Patient 2's clinical record indicated a Start of Care (SOC) date of 12/16/2019, with a diagnosis of hypertensive heart disease (heart problems that occur because of high blood pressure that is present over a long time) without heart failure. A review of Patient 2 's Plan of Care (POC) for certification period 01/29/2023 to 03/29/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for nine weeks. Further review of the POC indicated that the area for the physician signature was blank. A review of Patient 2 's Plan of Care (POC) for certification period 03/30/2023 to 5/28/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for eight weeks. Further review of the POC indicated that the area for the physician signature was blank. c. A review of Patient 3's clinical record indicated a Start of Care (SOC) date of 12/16/2019, with a diagnosis of type 2 diabetes mellitus (chronic condition that affects the way the body processes blood sugar). A review of Patient 3 's Plan of Care (POC) for certification period 03/30/2023 to 5/28/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for nine weeks. Further review of the POC indicated that the area for the physician signature was blank. d. A review of Patient 4's clinical record indicated a Start of Care (SOC) date of 05/04/2021, with a diagnosis of Parkinson’s Disease (a disorder of the central nervous system that affects movement, often tremors). A review of Patient 4's Plan of Care (POC) for certification period 04/24/2023 to 06/22/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for eight weeks. Further review of the POC indicated that the area for the physician signature was blank. e. A review of Patient 5's clinical record indicated a Start of Care (SOC) date of 12/09/2022 and a Discharge (DC) date of 01/07/2023, with a diagnosis of type 1 diabetes mellitus (chronic condition in which the pancreas produces little or no insulin) with hyperglycemia (high blood sugar). A review of Patient 3 's Plan of Care (POC) for certification period 12/09/2022 to 02/06/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for eight weeks. Further review of the POC indicated that the area for the physician signature was blank. During a concurrent record review and interview with the Director of Patient Care Services (DPCS), on 06/10/2023 at 12:46 p.m., she stated that plan of care should be signed by a physician within 30 days. A review of agency’s policy and procedure titled, “Physician Participation in Plan of Care” dated 10/2011, indicated that a physician will direct the care of every home health patient admitted for service and the attending physician will certify that medical, skilled, rehabilitation, and social services provided by the organization are medically required for the patient. The policy and procedure further indicated that orders are reviewed for appropriateness and accuracy before care, treatment and services are provided and attending physician will sign the plan of care/treatment within 30 days of start of care, unless otherwise specified by applicable state law and regulations. On 6/8/2023 at 5:54 pm, an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) was called in the presence of the agency’s Administrator (ADM) and ADM designee for the agency’s failure to: 1. For Patient 1, the agency did not follow the patient plan of care (POC) to notify the physician of systolic blood pressure greater than 160 or less than 90 and diastolic blood pressure greater than 90 or less than 60. During a joint home visit with agency’s LVN 1 on 6/7/23, the surveyor observed LVN 1 checked Patient 1's blood pressure and it was 88/44. LVN 1 did not recheck and did not notify the physician and did not report to the agency’s Director of Nursing Services (DPCS) or agency’s Administrator for further instruction. On the same day, 6/7/23, the surveyor and LVN 1 returned to the agency. A review of the skilled nurse’s notes dated 6/7/23 indicated LVN 1 documented Patient 1’s blood pressure as 110/90. However, the history of the blood pressure monitor indicated the patient’s blood pressure was 88/44. 2. The agency did not have DPCS, DPCS designee since 2/14/23, to assume the responsibility for clinical nursing needs. There was only one Registered Nurse that is currently on vacation and the agency did not have an RN to conduct a comprehensive assessment. 3. The agency has a census of 53 active patients. On 6/10/23 at 12:18 pm, the agency submitted an acceptable IJ removal plan that included the following: 1. Counseling and disciplinary action of LVN 1. 2. In-service of the agency’s nursing staff on home visit and clinical documentation that included to verify significant changes in vital signs for accuracy, to document any change to patient condition or vital signs and report to physician, case manager, supervisor, administrator on record, ask and investigate if medications adversely affected blood pressure and heart rate, and to verify patient’s overall condition is stable and vital signs are within normal limits. 3. Appointment of a Director of Patient Care Services (DPCS). On 6/10/23 at 3:11pm, the Survey Team removed the IJ after verifying and confirming onsite that the agency implemented the IJ removal plan in the presence of the ADM. Findings: a. A review of Patient 1's Patient Information Sheet indicated a Start of Care (SOC) on 5/1/2023, with primary diagnosis of malignant neoplasm (cancerous tumor) of the brain, unspecified and a secondary diagnosis of type 2 diabetes mellitus (DM, a chronic condition that affects the way the body processes blood sugar) with diabetic nephropathy (the deterioration of kidney function). A review of Patient 1’s Plan of Care (POC) for certification period 5/2/2023 to 6/30/2023, included an order for a Skilled Nurse (SN) to visit once a week for eight weeks. The SN was to perform assessment of patient with malignant neoplasm of brain, unspecified, and type 2 DM. The POC indicated to notify the physician if systolic blood pressure greater than 160 or less than 90 and diastolic blood pressure greater than 90 and less than 60. On 6/7/23 at 11:00 am, a joint home visit was conducted with Licensed Vocational Nurse (LVN 1) at Patient 1’s home residence. Patient 1 was lying in bed, alert and oriented, with electrodes (a device such as a small metal plate or needle that carries electricity from an instrument to a patient for treatment or surgery) on her head covered by a white net wrap. Caregiver (CG 1) translated for Patient 1 in her primary language and stated that Patient 1 was currently involved in a six-month study with General Acute Care Hospital (GACH 1) on her brain. LVN 1 took Patient 1’s vitals and Patient 1’s medications were checked. When asked what Patient 1’s blood pressure was, LVN 1 stated it was 88/44 and that it was low because Patient 1 was lying down. LVN 1 did not recheck Patient 1’s blood pressure. CG 1 stated to LVN 1 that Patient 1 needed a new blood pressure machine. During a telephone interview on 6/7/2023 at 12:30 pm, CG 1 stated that she did not have a working blood pressure machine, that when a blood pressure reading is taken, it will say error and that is why she asked for a new blood pressure machine. A record review of Patient 1’s Skilled Nursing notes dated 6/7/2023 indicated a blood pressure reading of 110/90. During a concurrent interview and record review on 6/7/2023 at 4:33 pm with LVN 1 in the HHA’s conference room, Patient 1’s Skilled Nursing (SN) note dated 6/7/2023 was reviewed and indicated that patient 1’s blood pressure was 110/90. When asked why the blood pressure reading, 88/44, taken during Patient 1’s home visit was not documented, LVN 1 stated to her knowledge, 110/90 was the value taken for Patient 1’s blood pressure. During a concurrent observation and interview on 6/7/2023 at 4:40 pm with LVN 1, LVN 1’s blood pressure monitor reading was observed as 88/44. LVN 1 stated she documented the wrong blood pressure and that she did not normally work in the field and do patient home visits. LVN 1 stated she could have written down Patient 1’s blood pressure or could have looked at her blood pressure cuff monitor for the correct blood pressure and documented it in the patient's electronic chart. During a concurrent interview and record review on 6/7/2023 at 4:46 pm with LVN 1, Patient 1’s POC was reviewed. The POC indicated to notify the physician if systolic blood pressure greater than 160 or less than 90 and diastolic blood pressure greater than 90 and less than 60. LVN 1 stated she did not notify the doctor and should have reached out to the physician to notify them that Patient 1’s blood pressure was low. During an interview on 6/8/2023 at 3:55 pm, LVN 1 stated she reported Patient 1’s low blood pressure to LVN 3, the patient’s primary nurse on 6/7/2023 and the Administrator designee (ADMD), after she spoke to the Surveyor, and that LVN 3 would go back to check on Patient 1 this week. LVN 1 stated that she had not talked to Patient 1’s family since yesterday. During a concurrent interview and record review on 6/8/2023 at 5 pm with LVN 1, Patient 1’s communication notes on the electronic chart dated 6/7/2023 were reviewed. Patient 1’s communication notes indicated Patient 1’s low blood pressure during home visit, that Patient 1 looked fine with no signs of distress and legs were elevated, and that nurse was not able to have patient sit up due to painful right leg. The communication note indicated that LVN 3 was made aware of situation and would see patient to recheck vitals. The communication note stated that that Patient 1’s primary physician was made aware of Patient 1’s low blood pressure and that LVN 1 called Patient 1’s family to check on Patient 1’s status. LVN 1 stated that CG 1 checked Patient 1’s blood pressure and reported to her that it was 134/78. When asked when the doctor was made aware and CG 1 called, LVN 1 stated it was done after she spoke to the Surveyor yesterday afternoon. During an interview on 6/8/2023 at 5:16 pm, CG 1 stated LVN 1 called her to take Patient 1’s vital signs, but she did not have a working blood pressure machine. CG 1 stated she took Patient 1’s blood pressure four times using her blood pressure machine and it said error, and finally, was able to get a number, 134/78. CG 1 stated the blood pressure machine she used was not working and needed a new one. CG 1 stated LVN 3 would not visit until Monday, 6/12/2023. During an interview on 6/8/2023 at 6:00 pm, the Administrator (ADM) stated that LVN 1 does not really have experience on the field and is mostly in the office. The ADM stated that maybe she should give LVN 1 more field experience because LVN 1 was studying to be a registered nurse. During an interview on 6/10/2023 at 12:32 pm, the Director of Patient Care Services (DPCS) stated that LVN 1 should have notified the case manager or the physician that Patient 1’s blood pressure was out of the parameters and asked what should be done with the patient. b. Patient 1 During an interview on 6/10/2023 at 12:40 pm, the Director of Patient Care Services (DPCS) stated that nurse should review the patient’s diagnosis and plan of care before seeing the patient and should follow the POC because it guides the nurse on what to do and provides continuity of care for the patient. A review of the HHA’s policy, “Care Planning Process,” dated 10/2011, indicated that 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. A review of the HHA’s policy, “Monitoring Patient’s Response/Reporting to Physician,” dated 10/2011, indicated that the patient's physician will be contacted on the same day when any of the following occur: A. Changes in the patient's condition A review of the HHA's policy, "Physician Participation in Plan of Care," dated 10/2011 indicated that the attending physician will sign the plan of care/treatment within 30 days of the start of care, unless otherwise specified by applicable state law and regulation.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interview, and record review, the Home Health Agency (HHA) failed to ensure the physician's orders in the plan of care were implemented for three of nine sampled patients (Patient 6, 7, and 9). This failure had the potential to result in patients not receiving the identified needs and services to attain or maintain the patient health status and well-being. A review of Patient 9’s Patient Information Sheet (Face Sheet) indicated that he had a start of care (SOC) date of 10/31/22 and on current episode 2/28/23 to 4/28/23. There was no primary diagnosis listed on the Face Sheet. A review of the electronic medical record (EMR) indicated that Patient 9’s current episode period was 4/29/23 to 6/27/23, not 2/28/23 to 4/28/23. Patient 9 did not have an OASIS (Outcome and Assessment Information Set: standardized data set that contains patient information such as, clinical condition, comorbidities, physical and mental state, functional status, living situation and healthcare needs), plan of care (485), or any orders on file. The EMR indicated that Patient 9 had skilled nursing visit notes for the following dates: 5/2/23, 5/9/23, 5/16/23, 5/23/23 and 5/30/23. All nursing visits were conducted by Licensed Vocational Nurse 2 (LVN 2). During an interview on 6/10/23, at 4:15pm, the Office Manager (OM) stated that Patient 9 should have been a non-admit because of his insurance did not approve him to have home health visits and LVN 2 should not have been seeing him. OM confirmed that Patient 9 did not have a care plan or OASIS, but did not know why. During an interview on 6/10/23, at 5:10pm, the Administrator (Admin) stated that she was unaware that Patient 9 was still getting visits. Admin stated that the nurses were told they needed to double check and make sure the patients had a 485 and OASIS before conducting visits, because only the active patients had 485 and OASIS. Admin stated that patients who no longer received services were still on the census, because there were no staff to audit charts and remove the inactive patients. Admin admitted that they were treating patients without permission from the medical director and their insurance company, and that is a liability. During an interview on 6/10/23, at 6:11pm, LVN 2 stated that he was visiting Patient 2 because he was told that they had authorization from Patient 9’s insurance, he could start conducting visits. LVN 2 stated that he did not check to see if Patient 9 had a 485, but he should have, because that is where you see the patient’s orders. LVN 2 stated when he visited Patient 9 he would check vitals, ask the care taker about the patient and check if Patient 9 had any new medications. LVN 2 stated that he always had to notify the office staff when he visited patients, so they were aware when he went. A review of the HHA’s policy, “Client Admission Process,” dated 6/27/1996 indicated that the admission professional will: a. Verify all the information on the Intake Form with the client/caregiver b. Complete the Assessment for, including OASIS data elements, Plan of care/485, Care Plan, Medication regime review, and additional documents, as required. The data gathered shall form the basis for the Plan of Care and Care Plan. A review of the HHA's policy titled "Care Planning Process", dated 10/2011, indicated the following... At the time of the initial assessment, the clinician, along with other involved disciplines, will develop the patient plan of care based upon the patient's identified needs and will review it with the patient and family/caregiver. The care planning decisions will be reflected in the specific services that will be provided and the associated actions planned and implemented to meet individualized patient problems and goals. 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. Findings: a. A review of Patient 6's Patient Information Sheet indicated a Start of Care (SOC) on 10/1/2021. A review of Patient 6’s Plan of Care (POC) for the certification period from 1/24/2023 to 3/24/2023 indicated a primary diagnosis for morbid (severe) obesity (abnormal or excessive fat accumulation that presents a risk to health) due to excess calories. The POC included an order for skilled nurse (SN) to visit once a week for seven weeks to perform assessment of patient with morbid obesity due to excess calories and chronic obstructive pulmonary disease (COPD, a condition involving constriction of the airways and difficulty or discomfort in breathing). The POC indicated to notify the physician of systolic blood pressure greater than 160 and less than 90 and diastolic blood pressure greater than 120 and less than 60. The POC was not signed by the physician. A review of Patient 6’s clinical record did not indicate that there was a POC for the certification periods from 3/25/2023 to 5/23/2023 or 5/24/2023 to 7/22/2023. A review of Patient 6’s Communication Note dated 5/9/2023 indicated that Patient 6 did not want the nurse to visit her anymore and to discharge her from HHA services. A review of Patient 6’s clinical chart did not indicate that the physician was notified that Patient 6 wanted to be discharged. A review of Patient 6’s Skilled Nursing (SN) note dated 5/17/2023 indicated LVN 5 performed a skilled observation of Patient 6’s vital signs and an assessment on Patient 6’s cardiovascular, respiratory, neurological, genitourinary, musculoskeletal, psychosocial, and digestive nutrition. Patient 6 had a blood pressure of 179/61 and the SN note indicated that wound dressing was performed on Patient 6’s lesions to right and left buttocks. A review of Patient 6’s SN note dated 5/24/2023 indicated that LVN 5 performed a skilled observation of Patient 6’s vital signs and an assessment on Patient 6’s cardiovascular, respiratory, neurological, genitourinary, musculoskeletal, psychosocial, and digestive nutrition. Patient 6 had a blood pressure of 161/84 and the SN note indicated that Patient 6’s bilateral leg dressing was cleaned and changed. A review of Patient 6’s SN note dated 5/31/2023 indicated that LVN 5 performed a skilled observation of Patient 6’s vital signs and an assessment on Patient 6’s cardiovascular, respiratory, neurological, genitourinary, musculoskeletal, psychosocial, and digestive nutrition. Patient 6 had a blood pressure of 190/56 and the SN note indicated that Patient 6’s bilateral wounds on lower extremities were cleaned and changed. b. A review of Patient 7's Patient Information Sheet indicated a Start of Care (SOC) on 4/26/2023 and a current episode from 4/26/2023 to 6/24/2023. The Patient information sheet indicated Skilled Nurse visit once a week for eight weeks. A review of the Patient 7’s clinical chart did not indicate that there was a POC for the certification period 4/26/2023 to 6/24/2023. A review of Patient 7’s SN note dated 4/28/2023 indicated that Registered Nurse (RN 1) performed a skilled observation of Patient 7’s vital signs and an assessment on Patient 7’s cardiovascular, respiratory, neurological, genitourinary, musculoskeletal, psychosocial, and digestive nutrition. The SN note indicated in the Skin Comments section that “wound care given, wet to dry.” During an interview on 6/10/2023 at 12:57 pm, the Director of Patient Care Services (DPCS) stated that the plan of care comes from the physician orders in Start of Care (SOC)/OASIS. The DPCS stated it was important to have a Plan of Care so that the visiting nurse knows what orders and treatments to perform for the patient and to provide the patient with continuity of care. A review of the HHA’s policy, “Care Planning Process,” dated 10/2011 indicated that at the time of the initial assessment, the clinician, along with other involved disciplines, will develop the patient plan of care based upon the patient's identified needs and will review it with the patient and family/caregiver. The policy further indicated that 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.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to report to the physician the change in patient condition for two of nine sampled patients (Patient 1 and Patient 8). For Patient 1, the HHA did not report to the physician when a blood pressure reading was 88/44. For Patient 8, the HHA did not report to the physician when a blood sugar reading was 509 mg/dL (milligram/deciliter). This deficient practice resulted in the delay of treatment that could place the patient's at risk for health and safety and hospitalization. Findings: a. A review of Patient 1's Patient Information Sheet indicated a Start of Care (SOC) on 5/1/2023, with primary diagnosis of malignant neoplasm (cancerous tumor) of the brain, unspecified and a secondary diagnosis of type 2 diabetes mellitus (DM, a chronic condition that affects the way the body processes blood sugar) with diabetic nephropathy (the deterioration of kidney function). A review of Patient 1’s Plan of Care (POC) for certification period 5/2/2023 to 6/30/2023, included an order for a Skilled Nurse (SN) to visit once a week for eight weeks. The SN was to perform assessment of patient with malignant neoplasm of brain, unspecified, and type 2 DM. The POC indicated to notify the physician if systolic blood pressure greater than 160 or less than 90 and diastolic blood pressure greater than 90 and less than 60. On 6/7/23 at 11:00 am, a joint home visit was conducted with Licensed Vocational Nurse (LVN 1) at Patient 1’s home residence. Patient 1 was lying in bed, alert and oriented, with electrodes (a device such as a small metal plate or needle that carries electricity from an instrument to a patient for treatment or surgery) on her head covered by a white net wrap. Caregiver (CG 1) translated for Patient 1 in her primary language and stated that Patient 1 was currently involved in a six-month study with General Acute Care Hospital (GACH 1) on her brain. LVN 1 took Patient 1’s vitals and Patient 1’s medications were checked. When asked what Patient 1’s blood pressure was, LVN 1 stated it was 88/44 and that it was low because Patient 1 was lying down. LVN 1 did not recheck Patient 1’s blood pressure. CG 1 stated to LVN 1 that Patient 1 needed a new blood pressure machine. During a telephone interview on 6/7/2023 at 12:30 pm, CG 1 stated that she did not have a working blood pressure machine, that when a blood pressure reading is taken, it will say error and that is why she asked for a new blood pressure machine. A record review of Patient 1’s nurses notes dated 6/7/2023 indicated a blood pressure reading of 110/90. During a concurrent interview and record review on 6/7/2023 at 4:33 pm with LVN 1 in the HHA’s conference room, Patient 1’s Skilled Nursing (SN) note dated 6/7/2023 was reviewed and indicated that patient 1’s blood pressure was 110/90. When asked why the blood pressure reading taken during Patient 1’s home visit was not documented, LVN 1 stated to her knowledge, 110/90 was the value taken for Patient 1’s blood pressure. During a concurrent observation and interview on 6/7/2023 at 4:40 pm with LVN 1, LVN 1’s blood pressure monitor reading was observed as 88/44. LVN 1 stated she documented the wrong blood pressure and that she did not normally work in the field and do patient home visits. LVN 1 stated she could have written down Patient 1’s blood pressure and document in the electronic chart or could have looked at her blood pressure cuff monitor for the correct blood pressure. During a concurrent interview and record review on 6/7/2023 at 4:46 pm with LVN 1, Patient 1’s POC was reviewed. The POC indicated to notify the physician if systolic blood pressure greater than 160 or less than 90 and diastolic blood pressure greater than 90 and less than 60. LVN 1 stated she did not notify the doctor and should have reached out to the physician to notify them that Patient 1’s blood pressure was low. During an interview on 6/8/2023 at 3:55 pm, LVN 1 stated she reported Patient 1’s low blood pressure to LVN 3, the patient’s primary nurse, yesterday and that LVN 3 would go back to check on Patient 1 this week. LVN 1 further stated she reported it to the Administrator designee (ADMD) and that she had not talked to Patient 1’s family since yesterday. During a concurrent interview and record review on 6/8/2023 at 5 pm with LVN 1, Patient 1’s communication notes on the electronic chart dated 6/7/2023 were reviewed. Patient 1’s communication notes indicated Patient 1’s low blood pressure during home visit, that Patient 1 looked fine with no signs of distress and legs were elevated, and that nurse was not able to have patient sit up due to painful right leg. The communication note indicated that LVN 3 was made aware of situation and would see patient to recheck vitals. The communication note stated that that Patient 1’s primary physician was made aware of Patient 1’s low blood pressure and that LVN 1 called Patient 1’s family to check on Patient 1’s status. LVN 1 stated that CG 1 checked Patient 1’s blood pressure and reported to her that it was 134/78. When asked when the doctor was made aware and CG 1 called, LVN 1 stated it was done after she spoke to the Surveyor yesterday afternoon. The communication note did not document the following from the physician notification: date and time contacted, name of physician or his/her representative, physician’s response, and action taken, or orders obtained. A phone call was attempted to Patient 1’s physician phone number on record and was noted to be a phone number of a for GACH 2 graduate medical school. The phone number was the same number indicated on the Patient 1’s Patient Information sheet and on Patient 1’s communication note documented by LVN 1 and dated 6/7/2023. b. A review of Patient 8's Patient Information Sheet indicated a Start of Care (SOC) on 9/9/2022, with primary diagnosis of sepsis (a serious condition in which the body responds improperly to an infection) and a secondary diagnosis of renal (related to kidney) and perinephric (around the kidney) abscess (a collection of pus that occurs due to a bacterial infection). A review of Patient 8’s Plan of Care (POC) for the certification period from 9/9/2022 to 11/07/2022, included an order for skilled nurse (SN) to visit once a week for nine weeks to perform comprehensive skilled nursing assessment, vital signs and to perform/monitor/teach the proper preparation and administration of Insulin Lispro 100 units/ml. The POC indicated that the SN to notify the physician if blood sugar was less than 70 milligram (mg)/deciliter (dL) or greater than 300 mg/dL. A review of Patient 8’s Skilled Nursing note dated 9/27/2022 indicated that Patient 8’s blood sugar level was 509 mg/dL. A review of Patient 8’s Communication note dated 9/27/2022 indicated that the case manager was notified regarding elevated random blood sugar and that caregiver reported that AM fasting blood sugar was 277 mg/dL. The communication note indicated that Patient 8 did not have signs and symptoms of hyperglycemia. A review of Patient 8’s clinical record did not indicate that the Physician was notified that on 9/27/2022, Patient 8’s had an elevated blood sugar level of 509 mg/dL. A review of Patient 8’s Missed visit forms dated 10/5/2022, 10/9/2022, 10/17/2022 and 10/24/2022 indicated that the nurse did not travel to see patient because Patient 8 was hospitalized. The Missed Visit forms indicated that no order was generated, and that the physician was not notified. A review of Patient 8’s Physician Order, dated 11/7/2022 indicated to discharge patient from HHA services due to transfer to the hospital. The order was not signed by a physician. During an interview on 6/9/2023 at 4:13 pm, Family Member (FM 2) stated that Patient 8 was hospitalized on 10/5/2022 and that she notified the HHA. FM 2 stated Patient 8 transferred to a rehabilitation center in 11/2022 and later died in 1/28/2023. During an interview on 6/10/2023 at 12:38 pm, the Director of Patient Care Services (DPCS) stated that the physician should have been notified of Patient 8’s critical high blood sugar level and Patient 8’s hospitalization. A review of the HHA’s policy, “Monitoring Patient’s Response/Reporting to Physician,” dated 10/2011, indicated that the patient's physician will be contacted on the same day when any of the following occur: A. Changes in the patient's condition B. Changes in the patient's psychosocial status, family/caregiver support, home environment C. Inability to achieve goals within the specified time frame D. Changes in the patient's expected response to treatment or medications E. Changes that have occurred regarding diagnoses, prognosis, or treatment (including procedures, medications, precautions, and limitations) F. When there is any problem implementing the plan of care G. When results are received for relevant laboratory tests ordered. All critical test results will be phoned to the physician within an agency designated time frame and will be read back and confirmed. The agency will collect data on the timeliness of reporting critical results to the physician. Data collected and assessed should include: the acceptable length of time between ordering of critical test and reporting the test results and the acceptable length of time between availability of critical test results and receipt by the responsible licensed caregiver. H. Patient is to be discharged from the organization, or a specific service is to be discontinued The policy indicated that all conferences or attempts to communicate with the physician will be documented in the clinical record. A. Documentation of physician notification will include: 1. Date and time contacted 2. Patient name 3. Name of physician notified or his/her representative 4. Reason for notification 5. Physician's response 6. Action taken or orders obtained 7. Professional's signature and title B. Documentation of attempted physician notification will include: 1. Date and time 2. Patient name 3. Name of physician attempting to notify 4. Reason for notification 5. Name of person taking message A review of the HHA’s policy, “Transfer/referral Criteria and Process”, dated 10/2011 indicated that when the patient’s plan of care changes and this change results in a transfer of referral, the patient, his/her representative, as well as his/her primary physician, will be notified and involved in planning decisions. The policy indicated that the patient may be transferred/referred only for the following reasons, which will be documented in the clinical record: 1. A change in condition requiring emergent care, hospitalization, or placement in an alternate care setting.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on interview and record review the home health agency (HHA) failed to implement and maintain an effective, ongoing, data-driven quality assessment and performance improvement program (QAPI). This deficient practice resulted in the HHA's lack of quality measures on developing patient care plan and agency's performance improvement. Findings: On 6/10/23, the HHA’s QAPI binder was reviewed. There were no QAPI meeting minutes, agenda, or sign-in sheets present. There were no documents present indicating that the HHA were focusing on any indicators to help improve health outcomes, patient safety, or quality of care. During an interview on 6/10/23, at 3:29 pm., with the Administrator stated that they have not had a QAPI meeting since February 2023. The HHA was unable to provide meeting minutes from February. The Administrator stated that the purpose of the performance improvement program is to follow trends, safety measure, and to address any issues related to patient care. A review of the HHA “Quality Assurance Performance Improvement Program”, dated 1/15/23, indicated that QAPI will become a vehicle to monitor patient care, treatment, and services with the goal of identifying and resolving any processes, functions and services that may adversely impact patient care. The scope of the program will include indicators across the spectrum of care including: a. adverse patient events b. infections and communicable diseases c. incidents, accidents, occurrences and variances d. ethical issues e. complaints and grievances f. worker compensation claims g. regulatory compliance The Agency’s governing body/owner are ultimately responsible for all actions and activities of the Agency’s QAPI program. The Agency's Clinical Manager is designated as a QAPI coordinator, a person responsible for coordinating Agency' QAPI activities. Information gathered related to the indicators will be included in the quarterly meeting minutes and the annual report.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview and record review, the Home Health Agency (HHA) failed to provide sharps container for disposal of needles for one of nine sampled patients (Patient 1). This deficient practice had the potential for an increased risk of cross contamination and spread of infection. Findings: a. A review of Patient 1's Patient Information Sheet indicated a Start of Care (SOC) on 5/1/2023, with primary diagnosis of malignant neoplasm (cancerous tumor) of the brain, unspecified and a secondary diagnosis of type 2 diabetes mellitus (DM, a chronic condition that affects the way the body processes blood sugar) with diabetic nephropathy (the deterioration of kidney function). A review of Patient 1’s Plan of Care (POC) for certification period 5/2/2023 to 6/30/2023, included an order for a Skilled Nurse (SN) to visit once a week for eight weeks. The SN was to perform assessment of patient with malignant neoplasm of brain, unspecified, and type 2 DM. The POC indicated in the Safety Measures section to instruct on proper handling of biohazard waste, standard precautions/infection control, and on sharps container. On 6/7/23, at 11 am., a joint home visit was conducted with Licensed Vocational Nurse (LVN 1) at Patient 1’s home residence. Patient 1 was lying in bed, alert and oriented, with electrodes (a device such as a small metal plate or needle that carries electricity from an instrument to a patient for treatment or surgery) on her head covered by a white net wrap. Caregiver (CG 1) translated for Patient 1 in her primary language and stated that Patient 1 was currently involved in a six-month study with General Acute Care Hospital (GACH 1) on her brain. LVN 1 took Patient 1’s vitals and Patient 1’s medications were checked. When CG 1 was asked how she disposes of the needles after she checks Patient 1’s blood sugar, CG 1 stated she placed it in a blue plastic candy container and then emptied the contents into the trash. During an interview on 6/10/2023, the Director of Patient Care Services (DPCS) stated that needles should be placed in a sharps container and that the patient should be provided one. The (DPCS) stated that sharps should not be thrown away in the trash and should be thrown in a sharps container to prevent anyone from getting hurt. A review of the HHA’s policy, “Infection Control Precautions,” dated 10/2011, indicated that based on the assessment and patient needs, the patient and family/caregiver will receive information and instruction on standard precautions, including such information as: A. Hand washing B. Protecting skin membranes C. Use of antiseptic cleaners D. Disposing of sharps in puncture-resistant containers… A review of the HHA’s policy, “Identification, Handling, and Disposal of Hazardous Waste,” dated 10/2011 indicated that patients will receive information and instruction regarding the identification, handling, and disposal of hazardous materials and wastes, in accordance with applicable law regulations.

Compliance with Federal, State, Local Law CFR(s): 484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients. The HHA and its staff must operate and furnish services in compliance with all applicable federal, state, and local laws and regulations related to the health and safety of patients. If state or local law provides licensing of HHAs, the HHA must be licensed. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Compliance with Federal, State, and Local Law as follows: 1. The HHA failed to ensure that the Administrator and Administrator designee had appropriate training and experience in health care administration, and the Licensed Vocational Nurses, (LVN 3 and LVN 4) had one-year prior professional nursing experience. (Refer to G 860) 2. The HHA failed to ensure that agency had an updated Clinical Laboratory Improvement Amendment waiver (CLIA, a federal program that regulates simple laboratory testing that requires certification by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing), while performing blood glucose (sugar) tests for one of nine sampled patients, (Patient 2). (Refer to G 862) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver mandated compliance with Federal, State, and Local Law to provide the highest quality of care and services to patients certified to receive home health services. .

Licensing CFR(s): 484.100(b) (b) Standard: Licensing. The HHA, its branches, and all persons furnishing services to patients must be licensed, certified, or registered, as applicable, in accordance with the state licensing authority as meeting those requirements. This STANDARD is not met as evidenced by: Based on interview, and record review, the Home Health Agency (HHA) failed to ensure that the Administrator and Administrator designee had appropriate training and experience in health care administration, and the Licensed Vocational Nurses, (LVN 3 and LVN 4) had one-year prior professional nursing experience This deficient practice had the potential for the provision of the highest quality patient care will not be delivered which could directly impact the patients' health and safety. c. A review of LVN 3’s employee records indicated a date of hire on 9/25/2022. A review of LVN 3’s license verification from the Board of Vocational Nursing indicated that Licensed Vocational Nurse license was issued on 12/22/2021. A review of LVN 3’s resume indicated that he had no prior LVN experience. A review of the California Code of Regulations Tittle 22, Article 3, § 74707(d) Skilled Nursing Services indicates that effective 1/1/1998, licensed vocational nurses providing services in a patient's temporary or permanent place of residence through a home health agency shall have one year prior professional nursing experience. Finding: a. On 06/06/2023 Administrator’s employee record was requested in order to review Administrator’s qualifications, but no file was provided. During an interview with the Administrator, on 06/06/2023 at 2:25 p.m., she stated that she did not have an employee file because she was no an employee. Administrator further stated that she does not have a current employee file. A review of the California Code of Regulations Tittle 22, Article 3, § § 74718 (b) Administrator indicates that a supervising physician or Director of Patient Care Services may also be the administrator. An administrator who is neither a physician or a registered nurse shall have training and experience in health service administration and at least one year of supervisory experience in home health care or health related programs. b. A review of the Administrator Designee’s employee record indicated a date of hire on 12/06/2017. Further review of Administrator Designee’s employee record indicated that there was no appointment letter for Administrator Designee on file. A review of the Administrator Designee’s signed job description dated 12/04/2017 indicated that job title/position was Licensed Vocational Nurse and no signed job description for Administrator Designee. A review of the Administrator Designee’s resume indicated that there was no training and experience in health care administration and no supervisory experience. A review of the California Code of Regulations Tittle 22, Article 3, § § 74718 (c) Administrator indicates that the administrator shall have a similarly qualified designee available in the administrator's absence During an interview with the Administrator Designee, on 06/06/2023 at 2:57 p.m., he stated that he is the Administrator Designee when Administrator is not available and that his official tittle is Case Manager. Administrator Designee further stated that he did not sign anything being appointed as Administrator Designee and that when he returned to the agency in 02/2023 he was told that he was Administrator Designee if Administrator is not available. d. A review of LVN 4’s employee records indicated a date of hire on 03/07/2023. A review of LVN 4’s license verification from the Board of Vocational Nursing indicated that Licensed Vocational Nurse license was issued on 06/01/2022. A review of LVN 4’s resume indicated that she had no prior LVN experience. A review of the California Code of Regulations Tittle 22, Article 3, § 74707(d) Skilled Nursing Services indicates that effective 1/1/1998, licensed vocational nurses providing services in a patient's temporary or permanent place of residence through a home health agency shall have one year prior professional nursing experience. During an interview with Licensed Vocational Nurse (LVN 4), on 06/09/2023 at 12:55 p.m., she stated that she prior to being hired at the HHA she did not have any LVN experience. LVN 4 further stated that she use to work at another HHA but as an office person not as an LVN. A review of agency’s job description titled, “Executive Director/Administrator” dated 10/2011, indicated that position qualifications include a bachelor’s degree in Business Administration, Masters degree in health care or related field preferred and at least three to five years experience in health care management preferably in health care management and at least one year of supervisory experience in home health care or health related programs. A review of agency’s job description titled, “Administrator Designee” undated, indicated that education and experience include a bachelor’s degree in health care administration, business administration, or related field. A review of agency’s job description titled, “Licensed Practical/Vocational Nurse” dated 10/2011, indicated that position qualifications effective 01/01/1998, shall have one year prior professional nursing experience in community/home health or medical/surgical experience.

Laboratory services/CLIA waivers CFR(s): 484.100(c)(1) Laboratory services. If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient's equipment when assisting with self-administered tests. This STANDARD is not met as evidenced by: Based on observation, interview and record review the Home Health Agency (HHA) failed to ensure that agency had an updated Clinical Laboratory Improvement Amendment waiver (CLIA, a federal program that regulates simple laboratory testing that requires certification by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing), while performing blood glucose (sugar) tests for one of nine sampled patients, (Patient 2). This deficient practice has resulted in the skilled nurse performing blood glucose test on a patient without a CLIA waiver. A review of Patient 3's clinical record indicated a Start of Care (SOC) date of 12/16/2019, with a diagnosis of type 2 diabetes mellitus (chronic condition that affects the way the body processes blood sugar). A review of Patient 3 's Plan of Care (POC) for certification period 5/29/2023 to 7/27/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for eight weeks. On 6/7/2023, at 12:10 p.m., a joint home visit with the Licensed Vocational Nurse (LVN 2) was conducted at Patient 3’s residence. During the home visit Patient 3 was observed sitting on a chair and Licensed Vocational Nurse (LVN 2) was observed performing blood sugar via a fingerstick to check on the patient’s blood sugar levels. A review of the Clinical Laboratory Improvement Amendment waiver (CLIA, a federal program that regulates simple laboratory testing that requires certification by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing), certificate provided by the agency indicated that the waiver expired on 08/01/2018. A current CLIA waiver was requested but the provider was unable to provide. During an interview with the Administrator on 6/7/2023, at 4:04 p.m., she stated that the agency does not have an updated CLIA waiver. The Administrator further stated that the agency has instructed the nurses not to perform blood sugar check and only teach the patient how to do it themselves. During an interview with Licensed Vocational Nurse (LVN 2) on 6/9/2023, at 12:10 p.m., he stated that Patient 3 had been his patient since he started at the agency and that during home visits, he performs the blood sugar check because Patient 3 does not like to do it himself. LVN 2 stated he was not aware that he was not supposed to check patient’s blood sugar and that no one from the agency told him. LVN 2 further stated he had tried to teach Patient 3 how to check his own blood sugar, but patient was scared and did not want to do it. The policy and procedure regarding diabetes and blood sugar monitoring was requested but the provider was unable to provide the document.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on interview and record review the home health agency (HHA) failed to employ qualified personnel by failing to: - Ensure Registered Nurse (RN 1) and Licensed Vocational Nurse (LVN 2, LVN 3, LVN 4, LVN 5, LVN 6), had updated History and Physical examinations. - Ensure Registered Nurse (RN 1) and Licensed Vocational Nurse (LVN 2, LVN 3, LVN 4, LVN 5, LVN 6), had an updated Purified Protein Derivative (PPD) skin test (test that determines if you have tuberculosis [serious lung infection]). - Ensure that Licensed Vocational Nurse (LVN 6) had an updated Basic Life Support Certificates. - Ensure Registered Nurse (RN 1) and Licensed Vocational Nurse (LVN 1, LVN 2, LVN 3, LVN 4, LVN 5), had a competency assessment. The deficient practice had the potential risk for these patients not to receive quality of care and services provided by the unqualified personnel. Findings: b. A review of LVN 2 employee records indicated a date of hire on 01/26/2022. There was no current history and physical examination or PPD on file. A review of LVN 2’s Initial Competency Assessment Skills Checklist indicated that LVN 2 signed the document on 01/21/2022 but there was no signature from the supervisor or preceptor. Further review of LVN 2’s Initial Competency Assessment Skills Checklist indicated that a self-assessment was conducted but no competency validation was conducted by a preceptor. d. A review of LVN 4’s employee records indicated a date of hire on 03/07/2023. There was no current history and physical examination or PPD on file. A review of LVN 4’s Initial Competency Assessment Skills Checklist indicated that LVN 4 signed the document on 03/06/2023 but there was no signature from the supervisor or preceptor. Further review of LVN 4’s Initial Competency Assessment Skills Checklist indicated that a self-assessment was conducted but no competency validation was conducted by a preceptor. e. A review of LVN 5’s employee records indicated a date of hire on 02/06/2023. There was no current history and physical examination or PPD on file. A review of LVN 5’s Initial Competency Assessment Skills Checklist indicated that LVN 5 signed the document on 02/03/2023 but there was no signature from the supervisor or preceptor. Further review of LVN 5’s Initial Competency Assessment Skills Checklist indicated that a self-assessment was conducted but no competency validation was conducted by a preceptor. f. A review of LVN 6’s employee records indicated a date of hire on 12/06/2017. There was no current history and physical examination or PPD on file. A review of LVN 6’s Basic Life Support Certificate indicated that it expired on 12/2018 g. A review of RN 1’s employee records indicated a date of hire on 01/23/2023. There was no current history and physical examination or PPD on file. A review of RN 1’1s Initial Competency Assessment Skills Checklist indicated that RN 1 signed the document on 01/24/2023 but there was no signature from the supervisor or preceptor. Further review of RN 1’s Initial Competency Assessment Skills Checklist indicated that a self-assessment was conducted but no competency validation was conducted by a preceptor. During an interview with Human Resource (HR), on 06/06/2023 at 3:13 p.m. and 06/07/2023 at 2:45 p.m., she stated that she is responsible for maintaining the employee files. HR stated that the Administrator is the one who performs the competency assessments, and that competency should be done in the beginning. HR stated that history and physical and PPD should be done during beginning and updated annually. HR further stated that Registered Nurse (RN) 1 did not do a competency validation because she had 12 years of experience. During a concurrent record review and interview with the Director of Patient Care Services (DPCS), on 06/10/2023 at 12:59 p.m., she stated that the DPCS should be the one doing the competency assessment of the nursing staff and validating the competency assessment checklist. A review of agency’s policy and procedure titled, “Personnel Records Contents” dated 10/2011, indicated that the agency will maintain accurate and complete personnel files on all staff. The policy and procedure further indicated that the content of the personnel files for regular full or part-time personnel will include: skills and experience inventory, CPR certification, performance evaluations and competency assessments for patients care staff, organization personnel performance observation reports (clinical only), TB Mantoux test documentation, and physician’s statement of health. a. A review of Patient 1's Patient Information Sheet indicated a Start of Care (SOC) on 5/1/2023, with primary diagnosis of malignant neoplasm (cancerous tumor) of the brain, unspecified and a secondary diagnosis of type 2 diabetes mellitus (DM, a chronic condition that affects the way the body processes blood sugar) with diabetic nephropathy (the deterioration of kidney function). A review of Patient 1’s Plan of Care (POC) for certification period 5/2/2023 to 6/30/2023, included an order for a Skilled Nurse (SN) to visit once a week for eight weeks. The SN was to perform assessment of patient with malignant neoplasm of brain, unspecified, and type 2 DM. The POC indicated to notify the physician if systolic blood pressure greater than 160 or less than 90 and diastolic blood pressure greater than 90 and less than 60. A review of LVN 1 employee records indicated a date of hire on 6/3/2022. There was no current history and physical examination or PPD on file. A review of LVN 1’s Initial Competency Assessment Skills Checklist indicated that LVN 1 signed the document on 6/3/2022 and the Administrator (inactive RN license) signed as Supervisor on 6/5/2022. Further review of LVN 1’s Initial Competency Assessment Skills Checklist indicated that a self-assessment was conducted but no competency validation was conducted by a preceptor. On 6/7/23 at 11:00 am, a joint home visit was conducted with Licensed Vocational Nurse (LVN 1) at Patient 1’s home residence. Patient 1 was lying in bed, alert and oriented, with electrodes (a device such as a small metal plate or needle that carries electricity from an instrument to a patient for treatment or surgery) on her head covered by a white net wrap. LVN 1 took Patient 1’s vitals and Patient 1’s medications were checked. When asked what Patient 1’s blood pressure was, LVN 1 stated it was 88/44 and that it was low because Patient 1 was lying down. LVN 1 did not recheck Patient 1’s blood pressure. CG 1 stated to LVN 1 that Patient 1 needed a new blood pressure machine. A record review of Patient 1’s Skilled Nursing notes dated 6/7/2023 indicated a blood pressure reading of 110/90. During a concurrent interview and record review on 6/7/2023 at 4:33 pm with LVN 1 in the HHA’s conference room, Patient 1’s Skilled Nursing (SN) note dated 6/7/2023 was reviewed and indicated that patient 1’s blood pressure was 110/90. When asked why the blood pressure reading, 88/44, taken during Patient 1’s home visit was not documented, LVN 1 stated to her knowledge, 110/90 was the value taken for Patient 1’s blood pressure. During a concurrent observation and interview on 6/7/2023 at 4:40 pm with LVN 1, LVN 1’s blood pressure monitor reading was observed as 88/44. LVN 1 stated she documented the wrong blood pressure and that she did not normally work in the field and do patient home visits. LVN 1 stated she could have written down Patient 1’s blood pressure or could have looked at her blood pressure cuff monitor for the correct blood pressure and documented it in the patient's electronic chart. During a concurrent interview and record review on 6/7/2023 at 4:46 pm with LVN 1, Patient 1’s POC was reviewed. The POC indicated to notify the physician if systolic blood pressure greater than 160 or less than 90 and diastolic blood pressure greater than 90 and less than 60. LVN 1 stated she did not notify the doctor and should have reached out to the physician to notify them that Patient 1’s blood pressure was low. During an interview on 6/8/2023 at 6:00 pm, the Administrator (ADM) stated that LVN 1 does not really have experience on the field and is mostly in the office. The ADM stated that maybe she should give LVN 1 more field experience because LVN 1 was studying to be a registered nurse. During an interview on 6/10/2023 at 12:32 pm, the Director of Patient Care Services (DPCS) stated that LVN 1 should have notified the case manager or the physician that Patient 1’s blood pressure was out of the parameters and asked what should be done with the patient. c. A review of LVN 3 employee records indicated a date of hire on 9/25/2022. There was no current history and physical examination or PPD on file. A review of LVN 3’s Initial Competency Assessment Skills Checklist indicated that LVN 3 signed the document on 9/25/2022 and the Administrator (inactive RN license) signed as Supervisor on 10/1/2022. Further review of LVN 3’s Initial Competency Assessment Skills Checklist indicated that a self-assessment was conducted but no competency validation was conducted by a preceptor. During an interview on 6/10/2023 at 1:04 pm, the DPCS stated that the nurse who performs the training and competency assessment should be a registered nurse with an active license.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on interview and record review, the home health agency (HHA) agency failed to ensure the Condition of Participation for Clinical Records was met as follows: 1. The HHA failed to follow their discharge policy by not completing a discharge summary within 48 hours for one of nine patients (Patient 8). Refer to G 1022 2. The HHA failed to ensure that the patient clinical records were completed and signed for four of nine sampled patients (Patient 1, 2, 3 and 4). Refer to G 1024 The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver mandated compliance with Federal regulations for Clinical Records to ensure highest quality healthcare is provided to patients assessed to receive home health services. .

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to follow their discharge policy by not completing the discharge summary within 48 hours for one of nine sampled patients (Patient 8). This failure had the potential to affect the patient's outcome and post discharge instructions. Findings: A review of Patient 8's Patient Information Sheet indicated a Start of Care (SOC) on 9/9/2022, with primary diagnosis of sepsis (a serious condition in which the body responds improperly to an infection) and a secondary diagnosis of renal (related to kidney) and perinephric (around the kidney) abscess (a collection of pus that occurs due to a bacterial infection). A review of Patient 8’s Plan of Care (POC) for the certification period from 9/9/2022 to 11/07/2022, included an order for skilled nurse (SN) to visit once a week for nine weeks to perform comprehensive skilled nursing assessment, vital signs and to perform/monitor/teach the proper preparation and administration of Insulin Lispro 100 units/ml. The POC indicated for the SN to notify the physician if blood sugar was less than 70 milligram (mg)/deciliter (dL) or greater than 300 mg/dL. A review of Patient 8’s Discharge Summary dated 11/7/2022 indicated the discharge date was 11/27/2022. The summary indicated the reason for discharge indicated Patient 8 was hospitalized and that the HHA received a call from the family Patient 8 was hospitalized on 10/5/2022. The Signature/Discipline was “PT Healthy Life” and was not dated. During an interview on 6/9/2023 at 4:13 pm., Family Member (FM 2) stated Patient 8 was hospitalized on 10/5/2022 and that she notified the HHA. FM 2 stated Patient 8 was transferred to a rehabilitation center in 11/2022 and later died in 1/28/2023. During an interview on 6/10/2023 at 12:40 pm., the Director of Patient Care Services (DPCS) stated when a patient transfers from the HHA, the nurse should complete resumption of care or discharge summary within 48 hours. The summary should have been filed in the clinical record within 72 hours. A review of the HHA’s policy, “Transfer/referral Criteria and Process”, dated 10/2011 indicated that when the patient’s plan of care changes and this change results in a transfer of referral, the patient, his/her representative, as well as his/her primary physician, will be notified and involved in planning decisions. The policy indicated that the patient may be transferred/referred only for the following reasons, which will be documented in the clinical record: 1. A change in condition requiring emergent care, hospitalization, or placement in an alternate care setting. A review of the HHA’s policy, “Transfer Summary”, dated 10/2011 indicated that all patients transferred from the organization will have a transfer summary completed and filed in the clinical record. The policy stated that within 48 hours of transfer, the transferring clinician will complete a transfer summary that includes, as appropriate: A. The reason for transfer B. The physical and psychosocial status a'. the time of transfer, including specific medical, psychosocial, or other problems requiring interventions or follow-up C. Continuing symptom management needs D. Medication profile E. A summary of the care provided, and the progress toward achieving goals F. Any instructions and/or referrals provided to the patient G. The existence of any Advance Directives known to the organization H. Date of face-to-face encounter, if during initial certification I. The date of transfer, which is the date of the last visit made

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 four of nine sampled patients (Patients 1, 2, 3 and 4). The deficient practice resulted in incomplete clinical records. Findings: b. A review of Patient 2's clinical record indicated a Start of Care (SOC) date of 12/16/2019, with a diagnosis of hypertensive heart disease (heart problems that occur because of high blood pressure that is present over a long time) without heart failure. A review of Patient 2 's Plan of Care (POC) for certification period 01/29/2023 to 03/29/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for nine weeks. Further review of the POC indicated that the area for the physician signature was blank. A review of Patient 2 's Plan of Care (POC) for certification period 03/30/2023 to 5/28/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for eight weeks. Further review of the POC indicated that the area for the physician signature was blank. A review of Patient 2’s Physician Order dated 01/29/2023 and 03/30/2023 indicated that the areas for the clinician and physician signatures were blank. A review of Patient 2’s OASIS (Outcome and Assessment Information Set, a patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality) dated 01/28/2023 and 03/29/2023, indicated that there was no signature from the nurse who completed the assessment. c. A review of Patient 3's clinical record indicated a Start of Care (SOC) date of 12/16/2019, with a diagnosis of type 2 diabetes mellitus (chronic condition that affects the way the body processes blood sugar). A review of Patient 3 's Plan of Care (POC) for certification period 03/30/2023 to 5/28/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for nine weeks. Further review of the POC indicated that the area for the physician signature was blank. A review of Patient 3’s Physician Order dated 03/30/2023 and 05/29/2023 indicated that the areas for the clinician and physician signatures were blank. A review of Patient 3’s OASIS dated 03/29/2023 and 05/28/2023, indicated that there was no signature from the nurse who completed the assessment. d. A review of Patient 4's clinical record indicated a Start of Care (SOC) date of 05/04/2021, with a diagnosis of Parkinson’s Disease (a disorder of the central nervous system that affects movement, often tremors). A review of Patient 4's Plan of Care (POC) for certification period 04/24/2023 to 06/22/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for eight weeks. Further review of the POC indicated that the area for the physician signature was blank. A review of Patient 4’s Physician Order dated 04/24/2023 indicated that the areas for the clinician and physician signatures were blank. A review of Patient 4’s OASIS dated 04/23/2023, indicated that there was no signature from the nurse who completed the assessment. e. A review of Patient 5's clinical record indicated a Start of Care (SOC) date of 12/09/2022 and a Discharge (DC) date of 01/07/2023, with a diagnosis of type 1 diabetes mellitus (chronic condition in which the pancreas produces little or no insulin) with hyperglycemia (high blood sugar). A review of Patient 3 's Plan of Care (POC) for certification period 12/09/2022 to 02/06/2023, indicated an order for a Skilled Nurse (SN) to visit the patient one time a week for eight weeks. Further review of the POC indicated that the area for the physician signature was blank. A review of Patient 5’s Physician Order dated 12/09/2022 and 01/07/2023 indicated that the areas for the clinician and physician signatures were blank. A review of Patient 5’s OASIS dated 12/09/2023 and 01/07/2023 indicated that there was no signature from the nurse who completed the assessment. A review of Patient 5’s Skilled Nursing Visit notes dated 12/10/2022, 12/12/2022, 12/14/2022 and 12/16/2022 indicated that there was no signature from the visiting nurse. Further review of Patient 5’s Skilled Nursing Visit notes dated 12/12/2022, 12/14/2022 and 12/16/2022 indicated the the nursing notes were incomplete. During a concurrent record review and interview with Licensed Vocational Nurse (LVN 2) on 06/09/2023 at 12:10 p.m., he stated that he did not know Patient 5 and did not do a home visit on the patient on 12/10/2022, 12/12/2022, 12/14/2022 and 12/16/2022. LVN 2 further stated that he does not know why his name is on the nursing notes dated 12/10/2022, 12/12/2022, 12/14/2022 and 12/16/2022 because he never visited Patient 5. During a concurrent record review and interview with Registered Nurse (RN 1) on 06/09/2023 at 1:16 p.m., she stated that she did not see Patient 3 on 05/28/2023 and that she was out of the country. RN 1 stated that she is not sure why the OASIS dated 05/28/2023 has her name, because she did not do the visit and she did not create the OASIS. During a concurrent record review and interview with the Director of Patient Care Services (DPCS), on 06/10/2023 at 1:28 p.m., she stated OASIS, physician orders, nursing notes and plan of care should all be signed and dated. DPCS further stated that nursing notes should be completed before submission. A review of agency’s policy and procedure titled, “Entries into the Clinical Record” dated 10/2011, indicated that the home health personnel providing direct patient care and supervisory functions have authority to make entries into the clinical records and documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided. The policy and procedure further indicated that clinical notes will include care provided, date the service was provided (month, day, year, and signature of clinician and his/her credentials. a. A review of Patient 1's Patient Information Sheet indicated a Start of Care (SOC) on 5/1/2023, with primary diagnosis of malignant neoplasm (cancerous tumor) of the brain, unspecified and a secondary diagnosis of type 2 diabetes mellitus (DM, a chronic condition that affects the way the body processes blood sugar) with diabetic nephropathy (the deterioration of kidney function). A review of Patient 1’s Plan of Care (POC) for certification period 5/2/2023 to 6/30/2023, included an order for a Skilled Nurse (SN) to visit once a week for eight weeks. Further review of the POC indicated that the area for the physician signature was blank. A review of Patient 1’s OASIS (Outcome and Assessment Information Set, a patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality) dated 5/2/2023, indicated that there was no signature from the nurse who completed the assessment.