Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391
Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 757188 (X3) Date Survey Completed 05/16/2025
Name of Provider or Supplier Simple Touch Home Health Care, Inc Street Address, City, State 5250 Santa Monica Blvd Suite 211, Los Angeles, CA
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID Prefix Tag Summary Statement of Deficiencies

(Each deficiency should be preceded by full regulatory or LSC identifying information)
G0370 Reporting OASIS information
CFR(s): 484.45

Condition of participation: HHAs must electronically report all OASIS data collected in accordance with §484.55.


This CONDITION is not met as evidenced by:
Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation for Release of patient identifiable OASIS information was met as follows: 


1.     The Home Health Agency failed to ensure the OASIS accurately reflected the patients status for five of five sampled patients (Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12). (Refer to G374).

 

The cumulative effect of these systemic practices resulted in Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12, not having an accurate OASIS,  placing patient safety at risk by increasing the chance of errors in medication, treatment, and diagnoses; increasing the risk for a lack in continuity of care, poor coordination between clinicians such as nurses and physicians; and affect the patients’ care and services that could lead to hospitalization and death.
G0374 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 Home Health Agency (HHA) failed to ensure the OASIS accurately reflected the patients status for five of five sampled patients (Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12):

 

 1. Patient 8 had a start of care (SOC) on 3/27/2025, with diagnosis of radiculopathy lumbar region.  The OASIS-start of care assessment, dated 3/27/2025, indicated the Owner (OW), who is not a licensed nurse, completed the assessment.

 2. Patient 9 had SOC on 4/7/2025, with Type 2 DM with hyperglycemia. The OASIS-start of care assessment, dated 4/7/2025, indicated the OW, who is not a licensed nurse, completed the assessment.

 3. Patient 10 had a SOC on 3/28/2025 with diagnoses of Type 2 DM with hyperglycemia. The OASIS-start of care assessment, dated 3/28/2025 and OASIS-transfer, dated 5/10/2025 indicated the OW, who is not a licensed nurse, completed the assessment.

4. Patient 11 had a SOC on 4/7/2025, with diagnoses of Type 2 DM with hyperglycemia. The OASIS-start of care assessment, dated 4/7/2025 and OASIS-transfer, dated 5/8/2025 indicated the OW, who is not a licensed nurse, completed the assessment.

 

5. Patient 12 had a SOC on 4/9/2025, with diagnoses of chronic pain syndrome. The OASIS-start of care assessment, dated 4/9/2025, indicated the OW, who is not a licensed nurse, completed the assessment.

 

The cumulative effect of these systemic practices resulted in Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12, not having an accurate OASIS,  placing patient safety at risk by increasing the chance of errors in medication, treatment, and diagnoses; increasing the risk for a lack in continuity of care, poor coordination between clinicians such as nurses and physicians; and affect the patients’ care and services that could lead to hospitalization and death.

 

On 5/16/2025, at 11:51 a.m., the Department called 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 identified in the presence of the HHA’s Owner (OW) for failing to ensure the OASIS accurately reflected the patients status for five of five sampled patients (Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12).

On 5/26/2025 at 4:00 pm, the HHA was unable to submit an IJ removal plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely).


During an interview on 5/13/2025, at 1:34 p.m., the owner (OW) stated she was not a licensed nurse.

During an interview on 5/15/25 at 10:41 a.m. Registered Nurse 1 (RN 1) stated the start of care (SOC) assessment was on paper. RN 1 stated he brings the SOC assessment to the office within 2 days at the latest and gives the documents to the OW. RN 1 stated “someone” (stated doesn’t know who) puts it in in the electronic medical record (EMR) and he reviews it, makes sure it is okay.

During an interview on 5/15/2025, at 11:00 a.m., the OW stated that the doctor’s orders for Patients 8,9,10,11, and 12 should have been in the EMR. The OW reviewed the EMR and stated the doctor’s orders were not in the patient records and did not understand why they were not there. The OW stated she had uploaded the orders on 5/14/2025 and stated the EMR “sometimes doesn’t work.” The OW stated she would email the doctor’s orders to the survey team.

During an interview on 5/15/2025, at 11:12 a.m., RN 1 stated he did not document the SOC assessments (OASIS) because he did not have access to the EMR. RN 1 then stated he reviewed the OASIS for accuracy and signed the documents.

On 5/15/2025, at 1:35 p.m., the OW stated she did all of the OASIS for all the patients. The OW stated she used information from RN 1, the consultant, and doctors orders. The OW stated she signed the OASIS assessment so it can be complete because if it is not complete, visits cannot be added, and the plan of care cannot be done. The OW stated she documented all of the information on the OASIS assessment for all the patients.

A record review of Patient’s 8,9,10,11, and 12, did not indicate RN 1 had signed the OASIS.

On 5/13/2025, 5/14/2025, and 5/15/2025, there was no evidence of a doctor’s order indicating the treatments and services needed for Patients 8,9,10,11, and 12.

1.

During a review of Patient 8’s SOC Worksheet (Start of Care Worksheet, a document used by the HHA that contains patient’s personal information such as name, date of birth, insurance, primary physician, diagnosis, and the date the patient was admitted to the HHA), the SOC Worksheet indicated that Patient 8 was a fifty five-year-old female, who was admitted to the HHA on 3/27/2025, with diagnosis that included radiculopathy (occurs when a nerve root in the spine is compressed or irritated, which can lead to symptoms like pain, weakness, numbness, or tingling in the area served by the affected nerve), lumbar (the area of the spine between the thoracic [chest] area and the sacrum (a shield-shaped bony structure that is located at the base of the lumbar vertebrae and that is connected to the pelvis) region and hypertensive heart disease (heart problems that occur because of high blood pressure that is present over a long time).

During a review of Patient 8’s OASIS Start of Care Assessment, dated 3/27/2025, the OASIS Start of Care Assessment was signed by the OW and by Consultant 1.

The OASIS Start of Care Assessment indicated that Patient 8 had impaired hearing (speaker has to increase volume and speak distinctly), impaired vision (limited vision; not able to see newspaper headlines but can identify objects), and constant delirium (serious disturbance in mental abilities that results in confused thinking and reduced awareness of surroundings). The OASIS Start of Care Assessment indicated that Patient 8 was dependent on a walker (a mobility aid, specifically a frame with four legs, designed to assist individuals who have difficulty walking due to age-related mobility issues, injury, or other medical conditions) and lived with other people in the home around the clock.

During a joint home visit with Licensed Vocational Nurse 2 (LVN 2) on 5/1/4/2025, at 11 a.m., Patient 8 was observed alert and oriented to person, place, time, and situation (fully aware of who they are, where they are, what day it is, and what is happening around them). Patient 8 was also observed walking independently without any assistive device. Patient 8 stated she did not need a walker. Patient 8 stated she lived on her own. There was no other person observed at Patient 8’s home during the visit. Patient 8 was able to read the home visit consent on her own, verbalize understanding, and sign the consent on the designated space. No delirium was observed. Patient 8 was able to hear the surveyor and LVN 2 within normal distance and without the speaker having to increase the volume.

During an interview with Patient 8 on 5/14/2025 at 11:25 a.m., Patient 8 stated she was a published author. Patient 8 showed the surveyor and LVN 2 one of her books that was recently published.  

2.

During a review of Patient 9’s SOC Worksheet, the SOC Worksheet indicated that Patient 9 was an eighty one-year-old female, who was admitted to the HHA on 4/7/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose), essential hypertension (high blood pressure where the cause is not definitively known), and Alzheimer’s disease (a progressive, irreversible brain disorder that destroys nerve cells and damages the brain, which causes a gradual decline in memory, thinking, and behavior).

During a review of Patient 9’s OASIS Start of Care Assessment, dated 4/7/2025, the OASIS Start of Care Assessment was not signed. 

During a concurrent interview and record review with the OW on 5/15/2025, at 2:05 p.m., the OW reviewed the OASIS Start of Care Assessment for Patient 8 and Patient 9. The OW stated that she was the one who documented the OASIS Start of Care for Patient 8 and Patient 9 with the help of Consultant 1.  The OW stated that neither she nor Consultant 1 had seen Patient 8 and Patient 9. The OW stated that she based the information that she put in the OASIS Start of Care Assessment on the Registered Nurse (RN) who admitted the patients and conducted the comprehensive assessment. The OW stated that she and Consultant 1 were not RNs. The OW was not able to provide the full name, contact information, or contract/agreement she had for Consultant 1. The OW stated that Consultant 1 “only worked for a week.” The OW stated she did not know Consultant 1’s full name.

When the OW was requested to provide the surveyor with the comprehensive assessment done by the RN for Patient 8 and Patient 9, the OW was not able to provide the RN assessment for Patient 9. The OW stated that RN 2, who conducted the start of care assessment for Patient 9, was currently on vacation and was unavailable. The OW stated that RN 2 had Patient 8’s start of care assessment with her, as it was paper based. 

During a review of an untitled document, with Patient 8’s name on it, who the OW stated was the start of care assessment done by RN 1, the document indicated the completion date was 4/3/2025. The document was not signed to indicate it was completed by RN 1. The document indicated that Patient 8 was alert, oriented, disoriented, and forgetful (all boxes were checked). The document did not indicate that Patient 8 had impaired vision or impaired hearing. There was no other assessment of Patient 8’s body system.

On 5/15/2025, at 11:25 a.m., RN 1 stated he had to leave the HHA’s office because he had to see patients and therefore, he was not able to review Patient 8’s Start of Care Assessment. The survey  requested RN 1 to rejoin the survey the following day. The OW stated that RN 1 was not available the following day since he had to visit patients.

3a.

During a review of Patient 10’s SOC Worksheet, the SOC Worksheet indicated that Patient 10 was admitted to the HHA on 3/28/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose).

A record review on 5/13/2025 of Patient 10’s OASIS start of care assessment, dated 3/28/2025, indicated the assessment was completed by a Registered Nurse (RN, also known as a licensed nurse). Further review of the record indicated the OW signed the document. On 5/13/2025, there was only 1 OASIS assessment (start of care assessment). No other OASIS assessment was in Patient 10’s records. 

During an interview on 5/13/2025 at 2:55 p.m., the OW added Patient 10 to the census. The OW stated she had just added Patient 10 to the census because she was discharged from the hospital on 5/11/2025.

During an interview on 5/12/2025, at 3:21 p.m., the OW stated Patient 10 had agreed for a home visit on 5/14/2025.

During an interview on 5/13/2025, at 9:24 p.m., the OW stated the home visit for 5/14/2025 was cancelled because Patient 10 was in a rehabilitation unit since 5/11/2025.

During an interview on 5/15/2025 at 11:12 a.m. RN 1 reviewed the paper documents for Patient 10. RN 1 stated none of those documents were a start of care assessment because there was no information about mobility and DME (durable medical equipment). RN 1 stated he did an assessment for Patient 10 on 4/3/2025. 

During a concurrent interview and record review, on 5/15/2025, at 11:15 a.m., RN 1 reviewed the SOC paper documents and OASIS-start of care assessment, dated 3/28/2025. The OASIS indicated the assessment was done on 3/28/2025.  RN 1 stated the OASIS had components that were incorrect such as vital signs and immunizations. Further record reviews of the documents indicated discrepancies with the paper document and the OASIS. This included insulin. The paper document mentioned the dose of 13 units, but there was no name of the medication. The OASIS indicated the name of the medication Novolog, but no additional information was documented. The paper document indicated Patient 10 needed SN (skilled nurse) services twice a week for 2 weeks (2w2), followed by 5 times a week for 1 week (5w1), PT (physical therapy) services, and Medical Social Work (MSW) services. The OASIS did not reflect the need for MSW. The OASIS indicated SN and PT services, but no frequency was mentioned. The OASIS indicated all interventions were to be based on doctor’s orders.

During an interview on 5/15/2025, at 1:35 p.m., the OW stated Patient 10’s start of care OASIS assessment was done on 3/28/2025, not 4/3/2025. The OW stated RN 1’s assessment date was wrong.

3b. A record review on 5/15/2025 of Patient 10’s records indicated the presence of another OASIS assessment. The OASIS E1 transfer document indicated Patient 10 was hospitalized for the reason of dehydration, and an RN had completed the assessment on 5/10/2025. Further review of the record did not indicate a signature to indicate who had completed the document.

During an interview on 5/15/2025, at 1:43 p.m., the OW stated she had documented the information on the OASIS E1 transfer assessment. The OW stated she obtained all of the information documented from the consultant and Patient 10’s husband. The OW stated she did not have medical knowledge. The OW stated the consultant was not an RN.

4a.

During a review of Patient 11’s SOC Worksheet, the SOC Worksheet indicated that Patient 11 was admitted to the HHA on 4/7/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose). 

A record review on 5/13/2025 of Patient 11’s OASIS start of care assessment, dated 4/7/2025, indicated the assessment was completed by an RN. There was no signature on the document to specify the RN who did the assessment. On 5/13/2025, there was only 1 OASIS assessment (start of care assessment). No other OASIS assessment was in Patient 11’s records.

During an interview on 5/15/2025, at 3:15 p.m., the OW stated she did not have paper documents that the nurse did for the start of care assessment for Patient 11, to indicate the accuracy of the OASIS assessments. The OW stated she documented the information on the OASIS based on doctor’s orders and the information sent by the doctor.

During an interview on 5/13/25 at 3:20 p.m., the OW stated Patient 11 was hospitalized, and unable to do home visit.

4b.

A record review of Patient 11’s medical records on 5/15/25 indicated the presence of an additional OASIS assessment. This document was an OASIS transfer without discharge assessment, dated 5/8/2025. The document indicated the visit date was on 5/8/2025, but the assessment was completed on 5/7/2025. Further review of the document indicated the RN completed the assessment. The document was signed by the OW. The document indicated the reason Patient 11 was hospitalized was due to pneumonia (a condition that makes breathing difficult). 

During an interview on 5/15/2025 at 1:56 p.m., the OW stated she had documented on the OASIS transfer assessment based on what the nurse and consultant told her.

5.

During a review of Patient 12’s SOC Worksheet, the SOC Worksheet indicated that Patient 12 was admitted to the HHA on 4/9/2025, with diagnosis of chronic pain syndrome.  

A record review of Patient 12’s, OASIS-start of care assessment, dated 4/9/2025, indicated the OW, who is not a licensed nurse, completed the assessment.

During an interview on 5/15/2025, at 3:15 p.m., the OW stated she did not have paper documents that the nurse did for the start of care assessment for Patient 11, to indicate the accuracy of the OASIS assessments.

 A record review of the HHA’s undated document titled, Who Can Complete the OASIS, indicated, the Registered Nurse, primary clinician for most OASIS assessments, especially the start of care and recertification was responsible in completing the assess
G0570 Care planning, coordination, quality of care
CFR(s): 484.60

Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice.


This CONDITION is not met as evidenced by:
Based on interview and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient’s place of residence) failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare and Medicaid programs) for care planning, coordination of services, and quality of care was met as follows:

1.     The HHA failed to ensure that three of five sampled patients (Patient 9, Patient 10, and Patient 11) received home health services that are written in an individualized plan of care (a detailed, written document outlining the services and support an individual needs to meet their healthcare goals) that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a physician to address the management of health status of the patients. (Refer to G572).

 

This failure resulted in Patient 9, Patient 10, and Patient 11 receiving home health services without an individualized, written plan of care that included management of their medical conditions.

The cumulative effect of this systemic practice resulted in the failure of the HHA to deliver statutorily (decided and controlled by law) mandated compliance with federal regulation for care planning, coordination of services, and quality of care to ensure quality patient care was provided to the patients.
G0572 Plan of care
CFR(s): 484.60(a)(1)

Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan.


This STANDARD is not met as evidenced by:
Based on interview and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) failed to ensure that three of five sampled patients (Patient 9, Patient 10, and Patient 11) received home health services that are written in an individualized plan of care (POC, a detailed, written document outlining the services and support an individual needs to meet their healthcare goals) that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a physician to address the management of health status of the patients.

This failure resulted in Patient 9, Patient 10, and Patient 11 receiving home health services without an individualized, written plan of care that included management of their medical conditions.

On 5/16/2025, at 12:12 p.m., the State Survey Agency (SSA) called 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 Owner (OW) related to the agency’s failure to provide home health services that are written in an individualized plan of care (a detailed, written document outlining the services and support an individual needs to meet their healthcare goals) that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a physician to address the management of health status of the patients for three of five sampled patients (Patient 9, Patient 10, and Patient 11).

On 5/26/2025 at 4:00 p.m., the HHA was unable to submit an IJ removal plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely).


During a telephone interview with the Director of Patient Care Services (DPCS) on 5/13/2025, at 1:42 p.m., the DPCS stated that she did not go to the interdisciplinary meetings in person due to distance. The DPCS stated she lived far away from the HHA’s office. The DPCS stated she participated in the meetings through group texts and phone calls. When the DPCS was asked if she had access to the electronic health record system used by the HHA, the DPCS stated that she did not have access yet. The DPCS stated she was not sure if she could join the revisit survey because she had to attend to her own businesses, and she did not have time.

During an interview on 5/15/2025 at 10:44 a.m., Registered Nurse 1 (RN 1) stated he tried to do the plan of care (POC). The POC was based on what the doctor ordered. If after the assessment, additional interventions were needed, the doctor was notified, and the additional interventions were added to the POC. RN 1 stated he wrote the orders received from the doctor and gave it to the OW, for the purpose of amendments of the documentation. RN 1 stated he did not create the POC in the electronic medical record (EMR) and did not know who created the POC.

During an interview on 5/15/2025, at 11:00 a.m., the OW stated that the doctor’s orders for Patients 9,10, and 12 should have been in the EMR. The OW reviewed the EMR and stated the doctor’s orders were not in the patient records and did not understand why they were not there. The OW stated she had uploaded the orders on 5/14/2025 and stated the EMR “sometimes doesn’t work.” The OW stated she would email the doctor’s orders to the survey team.

On 5/15/2025, at 11:10 a.m., the OW stated the plan of care for all patients had been completed and the survey team should be able to view it on the EMR.

During an interview with the OW on 5/15/2025, at 2:55 p.m., the OW stated she created the plan of care for Patient 9, Patient 10, and Patient 11 and uploaded them to the EMR on the evening of 5/14/2025 with the help of a consultant. The OW stated the consultant gave her the information for the POC by e-mail, which she then transcribed to the EMR of Patient 9, Patient 10, and Patient 11. The OW stated she also received help from her other friends for the POC. The OW stated the consultant was not a Registered Nurse. The OW also stated the consultant had never seen the patients. The OW stated that it was the responsibility of a clinician, such as the DPCS, to complete the POC, but she completed the plan of care because she wanted to “take care of her business.”

a.

During a review of Patient 9’s SOC Worksheet (Start of Care Worksheet, a document used by the HHA that contains patient’s personal information such as name, date of birth, insurance, primary physician, diagnosis, and the date the patient was admitted to the HHA), the SOC Worksheet indicated that Patient 9 was an eighty one-year-old female, who was admitted to the HHA on 4/7/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose), essential hypertension (high blood pressure where the cause is not definitively known), and Alzheimer’s disease (a progressive, irreversible brain disorder that destroys nerve cells and damages the brain, which causes a gradual decline in memory, thinking, and behavior).

On 5/13/2025, during a review of Patient 9’s Home Health Certification and Plan of Care, for the certification episode of 4/7/2025 to 6/5/2025, the Home Health Certification and Plan of Care was not completed. The sections for the patient’s diagnosis, medications, DME (Durable Medical Equipment, any medical equipment used in the home to aid in a better quality of living) and supplies, safety measures, nutritional requirements, allergies, mental status, prognosis, orders for disciplines and treatments including amount/frequency/duration, and goals/rehabilitation potential/discharge plans were blank. There was no nurse’s signature and no physician’s signature to indicate that a Registered Nurse received the physician’s orders, and a physician reviewed the Home Health Certification and Plan of Care.

On 5/14/2025, during a review of Patient 9’s Home Health Certification and Plan of Care, for the certification episode of 4/7/2025 to 6/5/2025, the Home Health Certification and Plan of Care was not completed.

During a concurrent record review and interview with the Owner (OW) on 5/15/2025, at 11:55 a.m., the OW reviewed Patient 9’s Home Health Certification and Plan of Care on the electronic health record system. The OW confirmed the Home Health Certification and Plan of Care for Patient 9 was not completed. The OW stated, “Sometimes you can see it, sometimes you cannot see it.”

b.

During a review of Patient 10’s SOC Worksheet, the SOC Worksheet indicated that Patient 10 was admitted to the HHA on 3/28/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose).

 

A record review of Patient 10’s medical records on 5/13/2025, did not indicate the presence of a POC. A POC template was present, but there was no clinical information.

 

During an interview on 5/12/2025, at 3:21 p.m., the OW stated Patient 10 had agreed for a home visit on 5/14/2025.

 

During an interview on 5/13/2025, at 9:24 p.m., the OW stated the home visit for 5/14/2025 was cancelled because Patient 10 was in a rehabilitation unit since 5/11/2025.

 

A record review on 5/15/2025 of Patient 10’s records indicated the presence of The OASIS E1 transfer assessment, dated 5/10/2025. This document was not present on 5/13/2025, the day the revisit survey began. The document indicated Patient 10 was hospitalized for the reason of dehydration.

 

A record review on 5/15/2025 of Patient 10’s records indicated the presence of an unsigned plan of care titled, Home Health Certification and Plan of Care, for certification period 3/28/2025 to 5/26/2025. The record included nursing interventions as follows:

-Skilled nurse (SN) frequency as per MD ordered.

-SN to note blood pressure (BP) trends and report to doctor if BP less than 90/60, greater than 200/100, heart rate less than 60 beats per minute (bpm) or greater than 100 bpm. SN to report to MD in a timely manner of any significant findings or negative outcome.

 

During an interview on 5/15/2025, at 1:56 p.m., Licensed Vocational Nurse 1 (LVN 1) stated she found out Patient 10 was hospitalized due to “drastically low blood pressure”. LVN 1 stated Patient 10 was on dialysis (a mechanical process of removing waste from the body, when the kidneys do not work). LVN 1 stated she called Patient 10 on 5/5/2025 to confirm her home visit for 5/7/2025. At this time, she was already hospitalized and could not visit Patient 10 on 5/7/2025. LVN 1 stated prior to hospitalization, LVN 1 visited Patient 10 on 4/30/2025. LVN 1 stated Patient 10 had returned from the doctor’s office and new medications were prescribed. LVN 1 stated she had checked Patient 10’s blood pressure and it was “101 over 50 something, and the blood sugar was fine.” LVN 1 stated she had all her nursing note visit documents at home and wrote her visit notes in the EMR. LVN 1 stated no one wrote her notes. LVN 1 stated she entered the notes for Patient 10, but would have to double check.

 

A record review of Patient 10’s unsigned nursing visit notes indicated visits were made on 4/2/2025, 4/9/2025, 4/16/2025, 4/23/2025, 4/30/2025, and 5/7/2025.

 

A record review of Patient 10’s nursing visit note on 4/30/2025, indicated Patient 10’s blood pressure was 138/83. The blood pressure document did not support LVN 1’s interview of Patient 10’s blood pressure being “101 over 50 something” on 4/30/2025.

 

A record review of Patient 10’s nursing visit notes indicated a visit was documented on 5/7/2025, the day LVN 1 could not do a home visit due to Patient 10 being hospitalized.

 

A record review of Patient 10’s EMR, did not indicate any notes to indicate LVN 1 called the doctor to report Patient 10’s blood pressure of “101 over 50 something”.

 

c.

During a review of Patient 11’s SOC Worksheet, the SOC Worksheet indicated that Patient 11 was admitted to the HHA on 4/7/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose).

 

A record review of Patient 11’s medical records on 5/13/2025, did not indicate the presence of a POC.  A POC template was present, but there was no clinical information.

 

During an interview on 5/13/25 at 3:20 p.m., the OW stated Patient 11 was hospitalized, and unable to do home visit.

A record review on 5/15/2025 of Patient 11’s records indicated the presence of an unsigned plan of care titled, Home Health Certification and Plan of Care, for certification period 4/7/2025 to 6/5/2025. The primary diagnosis was listed as acute and chronic respiratory failure. Further review of the POC, did not indicate Patient 11 had Type 2 diabetes. The record included nursing interventions as follows:

-Skilled nurse (SN) frequency as per MD ordered.

-SN to monitor oxygen saturations every SN visit.

 

During an interview on 5/15/2025, at 2:02 p.m., LVN 1 stated Patient 11 had a scheduled home visit on 5/7/2025. LVN 1 stated she texted Patient 11’s daughter on 5/6/2025 to confirm the visit. LVN 1 stated Patient 11’s daughter texted LVN 1 back on 5/7/2025, to let her know he was back in the hospital but did not mention the reason. LVN 1 could not get more information about his hospitalization.

 

A record review of Patient 11’s unsigned nursing visit notes indicated visits were made on 4/10/2025, 4/14/2025, 4/17/2025, 4/22/2025, 4/19/2025, and 5/6/2025.

 

A record review of Patient 11’s SN visit note for 4/17/2025, did not indicate the SN monitored Patient 11’s  oxygen saturation.

 

A record review of Patient 11’s nursing visit notes indicated a visit was documented on 5/6/2025, the day LVN 1 texted Patient 11’s daughter to confirm the scheduled HV on 5/7/2025.

 

 

During a review of the HHA’s undated policy and procedure, titled “Plan of Care,” the policy and procedure indicated the HHA will develop and maintain a Plan of Care for each patient that is individualized, based on a comprehensive assessment, and established under the direction of the patient’s physician. The plan shall guide the home health team in delivering medically necessary services and will be reviewed and updated as the patient’s condition changes.

The policy and procedure indicated the plan of care must include but is not limited to:

•          Diagnoses and medical history

•          Functional limitations

•          Medications and treatments

•          Services and disciplines required (e.g., nursing, PT, OT, ST, MSW, HHA)

•          Visit frequency and duration

•          Nutritional needs

•          Safety measures

•          Discharge planning

•          Patient-specific goals and outcomes

•          Physician's signature and date
G0940 Organization and administration of services
CFR(s): 484.105

Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished.


This CONDITION is not met as evidenced by:
Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation for Organization and administration of service was met as follows:


1.     The Home Health agency failed to ensure a governing body assume responsibility for the operations of the HHA by failing to:

 

a.     Ensure the agency’s Director of Patient Care Services provided oversight to ensure the clinical records were completed for five of five sampled patients (Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12).

 

b.    Ensure the agency has a qualified Administrator who assumed responsibility for the day-to-day operations of the agency.

 

c.     Ensure the agency’s Administrator ensured a clinical manager was available during all operating hours. (Refer to G942).

 

The cumulative effect of these systemic practices resulted in Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12 did not have clinical notes to validate the services being received were according to a doctor’s orders and based on the needs of the patients. The lack of oversight placed all patients at risk of injury, hospitalization, and/or death by not ensuring patients were receiving quality care.
G0942 Governing body
CFR(s): 484.105(a)

Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program.


This STANDARD is not met as evidenced by:
Based on interview and record review, the Home Health Agency (HHA) failed to ensure a governing body assume responsibility for the operations of the HHA by failing to:

 

a.     Ensure the agency’s Director of Patient Care Services provided oversight to ensure the clinical records were completed for five of five sampled patients (Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12).

 

b.    Ensure the agency has a qualified Administrator who assumed responsibility for the day-to-day operations of the agency.

 

c.     Ensure the agency’s Administrator ensured a clinical manager was available during all operating hours.

 

This failure resulted in Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12 did not have clinical notes to validate the services being received were according to a doctor’s orders and based on the needs of the patients. The lack of oversight placed all patients at risk of injury, hospitalization, and/or death by not ensuring patients were receiving quality care.

 

On 5/16/2025, at 12:17 p.m., the Department called 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 identified in the presence of the HHA’s Owner (OW) for failing to ensure a governing body assume responsibility for the operations of the HHA.

On 5/26/2025 at 4:00 pm, the HHA was unable to submit an IJ removal plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely).


Patient 8 had a start of care (SOC) on 3/27/2025, with diagnosis of radiculopathy lumbar region.

 

Patient 9 had SOC on 4/7/2025, with Type 2 DM with hyperglycemia.

 

Patient 10 had a SOC on 3/28/2025 with diagnoses of Type 2 DM with hyperglycemia.

 

Patient 11 had a SOC on 4/7/2025, with diagnoses of Type 2 DM with hyperglycemia.

 

Patient 12 had a SOC on 4/9/2025, with diagnoses of chronic pain syndrome.

 

a.

A record review of the HHA’s organizational chart indicated the Director of Patient Care Services (DPCS) was also the Administrator (ADM). DON-Director of Nurses. An administrator designee (DPCS D) was also listed. The record indicated the owner’s (OW) role was Governing body/board of directors. CO/CFO/Secretary 100% ownership.

 

During an interview on 5/13/2025, at 12:22 p.m., the OW stated the DPCS and DPCSD were responsible for patient care.

During an interview on 5/13/2025, at 1:34 p.m., the OW stated she was responsible for the day-to-day operation of the HHA because this was a small home health agency, and she just needed a Registered Nurse to see the patients. The OW stated the last time the DPCS was in the agency was two weeks ago. The OW stated the ADM designee and DPCS designee as listed on the organizational chart, was a “designee on paper”, and had not worked at the HHA. The OW stated the DPCS was also the designee. The OW stated Registered Nurse 1 could cover the DPCS role as ADM, but RN 1 could not cover the DPCS role because he did not have at least 3 years experience.

On 5/13/2025, at 1:42 p.m., the DPCS stated she oversaw the nursing staff along with the OW. The DPCS stated the nurses consult with her through the phone and email. The DPCS stated she lived far away. The DPCS stated she did not do home visits. The DPCS supervised the nursing staff through calls, text messages, and “stuff like that”. The DPCS stated RN 1 did management duties. The DPCS stated she was not the administrator. The DPCS stated the last time she came to the office was in April 2025. The DPCS was asked if she was available to participate in the revisit survey: the DPCS stated, “I’m not sure if I am available with all of that.” The DPCS stated she preferred not to participate in the survey. The DPCS stated she had all of her businesses that she needed to attend to and did not have a lot of time. The DPCS stated her designee was RN 1. The DPCS stated she was not the administrator, and was under the impression that the OW was the ADM. The DPCS stated she did not have access to the electronic medical record (EMR).

 

During an interview on 5/15/2025 at 10:12 a.m., the OW stated that the DPCS was the ADM. The OW stated the DPCS doesn’t know that she is the ADM because the DPCS thinks the ADM is an office person who answers calls and does paperwork.

 

During an interview on 5/15/2025, at 10:33 a.m., RN 1 stated he was not hired to any management role including DPCS, supervisory, ADM, and administrator designee duties. RN 1 stated he had not supervised any Licensed Vocational Nurses for this HHA.

 

On 5/13/2025, 5/14/2025, 5/15/2025, and 5/16/2025, the DPCS was not available.

 

The effect of the DPCS not being in the agency with the patient care and the clinical operations was no oversight to ensure plan of care was done, visit notes entered in the medical record, doctor notes present, and OASIS done accurately.

 

b.

During a review of clinical records on 5/13/2025, there was no plan of care (POC, a detailed, written document outlining the services and support an individual needs to meet their healthcare goals) available for Patient 9, Patient 10, and Patient 11 on the electronic health record.

During a review of clinical records on 5/14/2025, there was no POC available for Patient 9, Patient 10, and Patient 11 on the electronic health record.

During a review of clinical records on 5/15/2025, Patient 9, Patient 10, and Patient 11 had completed POC on the electronic health record.

During an interview with the Owner (OW) on 5/15/2025 at 11 a.m., the OW stated she generated the POC for the three patients the night before (5/14/2025).

During an interview with the OW on 5/15/2025, at 2:55 p.m., the OW stated she created the POC for Patient 9, Patient 10, and Patient 11 and uploaded them to the electronic health record on the evening of 5/14/2025 with the help of a consultant. The OW stated the consultant gave her the information for the plan of care by e-mail, which she then transcribed to the electronic health record of Patient 9, Patient 10, and Patient 11. The OW stated she also received help from her other friends for the POC. The OW stated the consultant was not a Registered Nurse. The OW also stated the consultant had never seen the patients. The OW stated that it was the responsibility of a clinician, such as the DPCS, to complete the POC, but she completed the plan of care because she wanted to “take care of her business.”

During a review of clinical records on 5/13/2025, 5/14/2025, and 5/15/2025, there were no physician orders available for Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12.

During an interview with the OW on 5/15/2025, at 1:13 p.m., the OW stated the only order the physician wrote was the home health referral.

During a review of the physician order, the document did not indicate the type of home health services, interventions, medications, treatments, and goals for the patients. The referral document indicated “Home Health.”

During a review of clinical records on  5/13/2025, there were no nursing visit notes available for Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12 on the electronic health record.

During an interview with the OW on 5/15/2025 at 3:05 p.m., the OW that Licensed Vocational Nurse 1 (LVN 1) endorsed to her (OW) the patient’s information over the phone, which the OW then transcribed into the nursing visit note. The OW stated that has always been the practice of the HHA. Per OW, she entered the nursing visit notes for Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12. The OW acknowledged she was not a clinician.

1.

During a review of Patient 8’s SOC Worksheet (Start of Care Worksheet, a document used by the HHA that contains patient’s personal information such as name, date of birth, insurance, primary physician, diagnosis, and the date the patient was admitted to the HHA), the SOC Worksheet indicated that Patient 8 was a fifty five-year-old female, who was admitted to the HHA on 3/27/2025, with diagnosis that included radiculopathy (occurs when a nerve root in the spine is compressed or irritated, which can lead to symptoms like pain, weakness, numbness, or tingling in the area served by the affected nerve), lumbar (the area of the spine between the thoracic [chest] area and the sacrum (a shield-shaped bony structure that is located at the base of the lumbar vertebrae and that is connected to the pelvis) region and hypertensive heart disease (heart problems that occur because of high blood pressure that is present over a long time).

During a review of Patient 8’s OASIS Start of Care Assessment, dated 3/27/2025, the OASIS Start of Care Assessment was signed by the OW and by Consultant 1.

The OASIS Start of Care Assessment indicated that Patient 8 had impaired hearing (speaker has to increase volume and speak distinctly), impaired vision (limited vision; not able to see newspaper headlines but can identify objects), and constant delirium (serious disturbance in mental abilities that results in confused thinking and reduced awareness of surroundings). The OASIS Start of Care Assessment indicated that Patient 8 was dependent on a walker (a mobility aid, specifically a frame with four legs, designed to assist individuals who have difficulty walking due to age-related mobility issues, injury, or other medical conditions) and lived with other people in the home around the clock.

During a joint home visit with Licensed Vocational Nurse 2 (LVN 2) on 5/1/4/2025, at 11 a.m., Patient 8 was observed alert and oriented to person, place, time, and situation (fully aware of who they are, where they are, what day it is, and what is happening around them). Patient 8 was also observed walking independently without any assistive device. Patient 8 stated she did not need a walker. Patient 8 stated she lived on her own. There was no other person observed at Patient 8’s home during the visit. Patient 8 was able to read the home visit consent on her own, verbalize understanding, and sign the consent on the designated space. No delirium was observed. Patient 8 was able to hear the surveyor and LVN 2 within normal distance and without the speaker having to increase the volume.

During an interview with Patient 8 on 5/14/2025 at 11:25 a.m., Patient 8 stated that she had been visited by a nurse (LVN 1) and by a physical therapist from the HHA once a week. Patient 8 stated she was a published author. Patient 8 showed the surveyor and LVN 2 one of her books that was recently published. 

 

2.

During a review of Patient 9’s SOC Worksheet, the SOC Worksheet indicated that Patient 9 was an eighty one-year-old female, who was admitted to the HHA on 4/7/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose), essential hypertension (high blood pressure where the cause is not definitively known), and Alzheimer’s disease (a progressive, irreversible brain disorder that destroys nerve cells and damages the brain, which causes a gradual decline in memory, thinking, and behavior).

On 5/13/2025, during a review of Patient 9’s Home Health Certification and Plan of Care, for the certification episode of 4/7/2025 to 6/5/2025, the Home Health Certification and Plan of Care was not completed. The sections for the patient’s diagnosis, medications, DME (Durable Medical Equipment, any medical equipment used in the home to aid in a better quality of living) and supplies, safety measures, nutritional requirements, allergies, mental status, prognosis, orders for disciplines and treatments including amount/frequency/duration, and goals/rehabilitation potential/discharge plans were blank. There was no nurse’s signature and no physician’s signature to indicate that a Registered Nurse received the physician’s orders, and a physician reviewed the Home Health Certification and Plan of Care.

During a review of Patient 9’s clinical records on 5/13/2025, the Nurses Notes section in the electronic health record indicated there were 0 (zero) notes entered for the certification episode of 4/7/2025 to 6/5/2025. The Nurses Notes section indicated “empty category.”

During a review of Patient 9’s OASIS Start of Care Assessment, dated 4/7/2025, the OASIS Start of Care Assessment was not signed.

During a concurrent interview and record review with the OW on 5/15/2025, at 2:05 p.m., the OW reviewed the OASIS Start of Care Assessment for Patient 8 and Patient 9. The OW stated that she was the one who documented the OASIS Start of Care for Patient 8 and Patient 9 with the help of Consultant 1.  The OW stated that neither she nor Consultant 1 had seen Patient 8 and Patient 9. The OW stated that she based the information that she put in the OASIS Start of Care Assessment on the Registered Nurse (RN) who admitted the patients and conducted the comprehensive assessment. The OW stated that she and Consultant 1 were not RNs. The OW was not able to provide the full name, contact information, or contract/agreement she had for Consultant 1. The OW stated that Consultant 1 “only worked for a week.” The OW stated she did not know Consultant 1’s full name.

When the OW was requested to provide the surveyor with the comprehensive assessment done by the RN for Patient 8 and Patient 9, the OW was not able to provide the RN assessment for Patient 9. The OW stated that RN 2, who conducted the start of care assessment for Patient 9, was currently on vacation and was unavailable. The OW stated that RN 2 had Patient 8’s start of care assessment with her, as it was paper based.

During a review of an untitled document, with Patient 8’s name on it, who the OW stated was the start of care assessment done by RN 1, the document indicated the completion date was 4/3/2025. The document was not signed to indicate it was completed by RN 1. The document indicated that Patient 8 was alert, oriented, disoriented, and forgetful (all boxes were checked). The document did not indicate that Patient 8 had impaired vision or impaired hearing. There was no other assessment of Patient 8’s body system.

On 5/15/2025, at 11:25 a.m., RN 1 stated he had to leave the HHA’s office because he had to see patients and therefore, he was not able to review Patient 8’s Start of Care Assessment. The survey  requested RN 1 to rejoin the survey the following day. The OW stated that RN 1 was not available the following day since he had to visit patients.

 

3.

During a review of Patient 10’s SOC Worksheet, the SOC Worksheet indicated that Patient 10 was admitted to the HHA on 3/28/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose).

 

A record review on 5/13/2025 of Patient 10’s OASIS start of care assessment, dated 3/28/2025, indicated the assessment was completed by a Registered Nurse. Further review of the record indicated the OW signed the document. On 5/13/2025, there was only 1 OASIS assessment (start of care assessment). No other OASIS assessment was in Patient 10’s records.

 

During an interview on 5/13/2025 at 2:55 p.m., the OW added Patient 10 to the census. The OW stated she had just added Patient 10 to the census because she was discharged from the hospital on 5/11/2025.

 

During an interview on 5/12/2025, at 3:21 p.m., the OW stated Patient 10 had agreed for a home visit on 5/14/2025.

 

During an interview on 5/13/2025, at 9:24 p.m., the OW stated the home visit for 5/14/2025 was cancelled because Patient 10 was in a rehabilitation unit since 5/11/2025.

 

During an interview on 5/15/2025 at 11:12 a.m. RN 1 reviewed the paper documents for Patient 10. RN 1 stated none of those documents were a start of care assessment because there was no information about mobility and DME (durable medical equipment). RN 1 stated he did an assessment for Patient 10 on 4/3/2025.

 

During a concurrent interview and record review, on 5/15/2025, at 11:15 a.m., RN 1 reviewed the SOC paper documents and OASIS-start of care assessment, dated 3/28/2025. The OASIS indicated the assessment was done on 3/28/2025.  RN 1 stated the OASIS had components that were incorrect such as vital signs and immunizations. Further record reviews of the documents indicated discrepancies with the paper document and the OASIS. This included insulin. The paper document mentioned the dose of 13 units, but there was no name of the medication. The OASIS indicated the name of the medication Novolog, but no additional information was documented. The paper document indicated Patient 10 needed SN (skilled nurse) services twice a week for 2 weeks (2w2), followed by 5 times a week for 1 week (5w1), PT (physical therapy) services, and Medical Social Work (MSW) services. The OASIS did not reflect the need for MSW. The OASIS indicated SN and PT services, but no frequency was mentioned. The OASIS indicated all interventions were to be based on doctor’s orders.

 

During an interview on 5/15/2025, at 1:35 p.m., the OW stated Patient 10’s start of care OASIS assessment was done on 3/28/2025, not 4/3/2025. The OW stated RN 1’s assessment date was wrong.

 

4a.

During a review of Patient 11’s SOC Worksheet, the SOC Worksheet indicated that Patient 11 was admitted to the HHA on 4/7/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose).

 

A record review on 5/13/2025 of Patient 11’s OASIS start of care assessment, dated 4/7/2025, indicated the assessment was completed by an RN. There was no signature on the document to specify the RN who did the assessment. On 5/13/2025, there was only 1 OASIS assessment (start of care assessment). No other OASIS assessment was in Patient 11’s records.

 

During an interview on 5/15/2025, at 3:15 p.m., the OW stated she did not have paper documents that the nurse did for the start of care assessment for Patient 11, to indicate the accuracy of the OASIS assessments. The OW stated she documented the information on the OASIS based on doctor’s orders and the information sent by the doctor.

 

During an interview on 5/13/25 at 3:20 p.m., the OW stated Patient 11 was hospitalized, and unable to do home visit.

4b.

A record review of Patient 11’s medical records on 5/15/25 indicated the presence of an additional OASIS assessment. This document was an OASIS transfer without discharge assessment, dated 5/8/2025. The document indicated the visit date was on 5/8/2025, but the assessment was completed on 5/7/2025. Further review of the document indicated the RN completed the assessment. The document was signed by the OW. The document indicated the reason Patient 11 was hospitalized was due to pneumonia (a condition that makes breathing difficult).

 

During an interview on 5/15/2025 at 1:56 p.m., the OW stated she had documented on the OASIS transfer assessment based on what the nurse and consultant told her.

 

5.

During a review of Patient 12’s SOC Worksheet, the SOC Worksheet indicated that Patient 12 was admitted to the HHA on 4/9/2025, with diagnosis of chronic pain syndrome.

 

During a record review, Patient 12’s OASIS-start of care assessment, dated 4/9/2025, indicated the OW, who is not a licensed nurse, completed the assessment.

 

During an interview on 5/15/2025, at 3:15 p.m., the OW stated she did not have paper documents that the nurse did for the start of care assessment for Patient 11, to indicate the accuracy of the OASIS assessments.

 

A record review of the HHA’s undated document, titled Governing Body indicated, “Simple Touch Home Health shall maintain an active Governing Body with full legal authority and responsibility for the management, oversight, and operation of the agency. The Governing Body shall define the organization’s mission, ensure the provision of quality care, approve policies, and oversee fiscal and administrative operations. Composition: The Governing Body may include the agency’s owners, executives, Administrator, Director of Patient Care Services (DPCS), and other appointed members as appropriate.”

A record review of the HHA’s undated document titled, Job Description Summary for the Executive Director/Administrator, indicated the job responsibilities included ensuring organizational compliance with legal, regulatory, and accreditation standards; ensuring program personnel have current clinical information and current practices; assuring appropriate personnel supervision during all operating hours; is responsible for all day-to-day operation of the HHA; ensures that a clinical manager is available during all operating hours; the administrator or a pre-designated person is available during all operating hours.

A record review of the HHA’s undated document titled, Job Description Summary for the Clinical Director/Director of Patient Care Services, indicated the job responsibilities included: oversees the maintenance of patient clinical records, statistics, reports and records for purposes of evaluation and reporting of organization activities; assures proper maintenance of clinical records in compliance with local, state and federal laws; if the DPCS is also acting as the clinical manager: the clinical manager’s oversight must include the following:...coordinating patient care...assuring that patient needs are continually assessed, assuring the development, implementation, and updates of the individualized plan of care.
G1024 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 observation, interview and record review, the Home Health Agency failed to ensure that all clinical record entries were clear, complete, and appropriately authenticated, signed, dated, and timed for five of five sampled patients (Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12).

This failure had the potential for the patients’ clinical records to be lacking validity.


a.

During a review of Patient 8’s SOC Worksheet (Start of Care Worksheet, a document used by the HHA that contains patient’s personal information such as name, date of birth, insurance, primary physician, diagnosis, and the date the patient was admitted to the HHA), the SOC Worksheet indicated that Patient 8 was a fifty five-year-old female, who was admitted to the HHA on 3/27/2025, with diagnosis that included radiculopathy (occurs when a nerve root in the spine is compressed or irritated, which can lead to symptoms like pain, weakness, numbness, or tingling in the area served by the affected nerve), lumbar (the area of the spine between the thoracic [chest] area and the sacrum (a shield-shaped bony structure that is located at the base of the lumbar vertebrae and that is connected to the pelvis) region and hypertensive heart disease (heart problems that occur because of high blood pressure that is present over a long time).

During a review of Patient 8’s OASIS Start of Care Assessment, dated 3/27/2025, the OASIS Start of Care Assessment was signed by the OW and by Consultant 1.

During a review of Patient 8’s Home Health Certification and Plan of Care, for the certification episode of 3/27/2025 to 5/25/2025, the Home Health Certification and Plan of Care had no nurse’s signature and no physician’s signature to indicate that a Registered Nurse received the physician’s orders, and a physician reviewed the Home Health Certification and Plan of Care.

During a review of Patient 8’s clinical records on 5/13/2025, the Nurses Notes section in the electronic health record indicated there were 0 (zero) notes entered for the certification episode of 3/27/2025 to 5/25/2025. The Nurses Notes section indicated “empty category.”

 

b.

During a review of Patient 9’s SOC Worksheet, the SOC Worksheet indicated that Patient 9 was an eighty one-year-old female, who was admitted to the HHA on 4/7/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose), essential hypertension (high blood pressure where the cause is not definitively known), and Alzheimer’s disease (a progressive, irreversible brain disorder that destroys nerve cells and damages the brain, which causes a gradual decline in memory, thinking, and behavior).

During a review of Patient 9’s OASIS Start of Care Assessment, dated 4/7/2025, the OASIS Start of Care Assessment was not signed.

On 5/13/2025, during a review of Patient 9’s Home Health Certification and Plan of Care, for the certification episode of 4/7/2025 to 6/5/2025, the Home Health Certification and Plan of Care was not completed. The sections for the patient’s diagnosis, medications, DME (Durable Medical Equipment, any medical equipment used in the home to aid in a better quality of living) and supplies, safety measures, nutritional requirements, allergies, mental status, prognosis, orders for disciplines and treatments including amount/frequency/duration, and goals/rehabilitation potential/discharge plans were blank. There was no nurse’s signature and no physician’s signature to indicate that a Registered Nurse received the physician’s orders, and a physician reviewed the Home Health Certification and Plan of Care.

During a review of Patient 9’s clinical records on 5/13/2025, the Nurses Notes section in the electronic health record indicated there were 0 (zero) notes entered for the certification episode of 4/7/2025 to 6/5/2025. The Nurses Notes section indicated “empty category.”

During a telephone interview with Licensed Vocational Nurse 1 (LVN 1) on 5/15/2025, at 2:04 p.m., LVN 1 stated she was the visiting nurse for Patient 8 and Patient 9. According to LVN 1, she visited both patients once a week. LVN 1 stated that she documented her visit notes on paper, and she would later upload them to the electronic health record, depending on how busy she was. LVN 1 stated she had access to the electronic health record.

During a concurrent interview and record review with the OW on 5/15/2025, at 2:05 p.m., the OW reviewed the OASIS Start of Care Assessment for Patient 8 and Patient 9. The OW stated that she was the one who documented the OASIS Start of Care for Patient 8 and Patient 9 with the help of Consultant 1.  The OW stated that neither she nor Consultant 1 had seen Patient 8 and Patient 9. The OW stated that she based the information that she put in the OASIS Start of Care Assessment on the Registered Nurse (RN) who admitted the patients and conducted the comprehensive assessment. The OW stated that she and Consultant 1 were not RNs. The OW was not able to provide the full name, contact information, or contract/agreement she had for Consultant 1. The OW stated that Consultant 1 “only worked for a week.” The OW stated she did not know Consultant 1’s full name.

When the OW was requested to provide the surveyor with the comprehensive assessment done by the RN for Patient 8 and Patient 9, the OW was not able to provide the RN assessment for Patient 9. The OW stated that RN 2, who conducted the start of care assessment for Patient 9, was currently on vacation and was unavailable. The OW stated that RN 2 had Patient 9’s start of care assessment with her, as it was paper based. RN 2 was not listed in the staff list provided to the survey team.

During a review of clinical records on 5/13/2025, there were no nursing visit notes available for Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12 on the electronic health record.

During an interview with the OW on 5/15/2025 at 3:05 p.m., the OW that Licensed Vocational Nurse 1 (LVN 1) endorsed to her (OW) the patient’s   information over the phone, which the OW then transcribed into the nursing visit note. The OW stated that has always been the practice of the HHA. Per OW, she entered the nursing visit notes for Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12. The OW acknowledged she was not a clinician.

 

c.

During a review of Patient 10’s SOC Worksheet, the SOC Worksheet indicated that Patient 10 was admitted to the HHA on 3/28/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose).

A record review on 5/15/2025 of Patient 10’s records indicated the presence of an OASIS assessment. The OASIS E1 transfer document indicated Patient 10 was hospitalized for the reason of dehydration, and an RN had completed the assessment on 5/10/2025. Further review of the record did not indicate a signature to indicate who had completed the document.

A record review on 5/15/2025 of Patient 10’s records indicated the presence of an unsigned plan of care titled, Home Health Certification and Plan of Care, for certification period 3/28/2025 to 5/26/2025.

A record review of Patient 10’s nursing visit notes indicated visits were made on 4/2/2025, 4/9/2025, 4/16/2025, 4/23/2025, 4/30/2025, and 5/7/2025. None of these visit notes were signed by the author of the note.

 

During an interview on 5/15/2025, at 1:56 p.m., Licensed Vocational Nurse 1 (LVN 1) stated she had all of Patient 10’s nursing notes at her home. LVN 1 stated she wrote her visit notes on paper, then put them in the EMR. LVN 1 stated she tried to put the notes in the EMR the same day or the next day the latest. LVN 1 stated she thought she had entered Patient 10’s notes into the EMR,  but would have to double check.

 

d.

During a review of Patient 11’s SOC Worksheet, the SOC Worksheet indicated that Patient 11  was admitted to the HHA on 4/7/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose).

A record review on 5/15/2025 of Patient 11’s records indicated the presence of an unsigned plan of care titled, Home Health Certification and Plan of Care, for certification period 4/7/2025 to 6/5/2025.

A record review of Patient 11’s  nursing visit notes indicated visits were made on 4/10/2025, 4/14/2025, 4/17/2025, 4/22/2025, 4/19/2025, and 5/6/2025. None of these visit notes were signed by the author of the note.

 

e.

During a review of Patient 12’s SOC Worksheet, the SOC Worksheet indicated that Patient 12 was admitted to the HHA on 4/9/2025, with diagnosis of chronic pain syndrome.  

 

A record review of Patient 12’s  nursing visit notes indicated visits were made on 4/12/2025, 4/15/2025, 4/18/2025, 4/25/2025, 5/2/2025, and 5/9/2025. None of these visit notes were signed by the author of the note.

 

A record review of the HHA’s undated document titled, Contents of Medical records, indicated, “2. Documentation Standards: Entries must be legible, dated, times, and signed with credentials...Documentation should be completed within 24-48 hours of the visit or service, depending on urgency.”

A record review of the HHA’s undated document titled, Job Description Summary for the Clinical Director/Director of Patient Care Services, indicated the job responsibilities included: oversees the maintenance of patient clinical records, statistics, reports and records for purposes of evaluation and reporting of organization activities; assures proper maintenance of clinical records in compliance with local, state and federal laws.
G1028 Protection of records
CFR(s): 484.110(d)

Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164.


This STANDARD is not met as evidenced by:
Based on interview and record review, the Home Health Agency failed to ensure the safeguarding of clinical records against unauthorized access or loss for five of five sampled patients (Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12).

This failure had the potential to result in the patients’ protected health information (PHI, any information in the medical record or designated record set that can be used to identify an individual and that was created, used, or disclosed in the course of providing a health care service such as diagnosis or treatment) being accessed or used by unauthorized personnels, and loss of clinical records.


a.

During a review of Patient 8’s SOC Worksheet (Start of Care Worksheet, a document used by the HHA that contains patient’s personal information such as name, date of birth, insurance, primary physician, diagnosis, and the date the patient was admitted to the HHA), the SOC Worksheet indicated that Patient 8 was a fifty five-year-old female, who was admitted to the HHA on 3/27/2025, with diagnosis that included radiculopathy (occurs when a nerve root in the spine is compressed or irritated, which can lead to symptoms like pain, weakness, numbness, or tingling in the area served by the affected nerve), lumbar (the area of the spine between the thoracic [chest] area and the sacrum (a shield-shaped bony structure that is located at the base of the lumbar vertebrae and that is connected to the pelvis) region and hypertensive heart disease (heart problems that occur because of high blood pressure that is present over a long time).

During a review of Patient 8’s OASIS Start of Care Assessment, dated 3/27/2025, the OASIS Start of Care Assessment was signed by the OW and by Consultant 1.

During a review of Patient 8’s clinical records on 5/13/2025, the Nurses Notes section in the electronic health record indicated there were 0 (zero) notes entered for the certification episode of 3/27/2025 to 5/25/2025. The Nurses Notes section indicated “empty category.”

b.

During a review of Patient 9’s SOC Worksheet, the SOC Worksheet indicated that Patient 9 was an eighty one-year-old female, who was admitted to the HHA on 4/7/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose), essential hypertension (high blood pressure where the cause is not definitively known), and Alzheimer’s disease (a progressive, irreversible brain disorder that destroys nerve cells and damages the brain, which causes a gradual decline in memory, thinking, and behavior).

During a review of Patient 9’s OASIS Start of Care Assessment, dated 4/7/2025, the OASIS Start of Care Assessment was not signed.

During a concurrent interview and record review with the OW on 5/15/2025, at 2:05 p.m., the OW reviewed the OASIS Start of Care Assessment for Patient 8 and Patient 9. The OW stated that she was the one who documented the OASIS Start of Care for Patient 8 and Patient 9 with the help of Consultant 1.  The OW stated that neither she nor Consultant 1 had seen Patient 8 and Patient 9. The OW stated that she based the information that she put in the OASIS Start of Care Assessment on the Registered Nurse (RN) who admitted the patients and conducted the comprehensive assessment. The OW stated that she and Consultant 1 were not RNs. The OW was not able to provide the full name, contact information, or contract/agreement she had for Consultant 1. The OW stated that Consultant 1 “only worked for a week.” The OW stated she did not know Consultant 1’s full name.

When the OW was requested to provide the surveyor with the comprehensive assessment done by the RN for Patient 8 and Patient 9, the OW was not able to provide the RN assessment for Patient 9. The OW stated that RN 2, who conducted the start of care assessment for Patient 9, was currently on vacation and was unavailable. The OW stated that RN 2 had Patient 9’s start of care assessment with her, as it was paper based. RN 2 was not listed in the staff list provided to the survey team.

c.

During a review of Patient 10’s SOC Worksheet, the SOC Worksheet indicated that Patient 10 was admitted to the HHA on 3/28/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose).

During an interview on 5/15/2025, at 1:56 p.m., Licensed Vocational Nurse 1 (LVN 1) stated she had all of Patient 10’s nursing notes at her home. LVN 1 stated she wrote her visit notes on paper and then put them in the EMR. LVN 1 stated she tried to put the notes in the EMR the same day or the next day the latest.

d.

During a review of Patient 11’s SOC Worksheet, the SOC Worksheet indicated that Patient 11  was admitted to the HHA on 4/7/2025, with diagnosis that included type 2 diabetes mellitus (a chronic condition that occurs when the body cannot use insulin correctly and glucose [sugar] builds up in the blood) with hyperglycemia (excessively high blood glucose).

On 5/13/2025, 5/14/2025, and 5/15/2025, there was no evidence of paper documents used by the nurse for the start of care of Patient 11.  There was no paper consents present at the HHA.

e.

During a review of Patient 12’s SOC Worksheet, the SOC Worksheet indicated that Patient 12 was admitted to the HHA on 4/9/2025, with diagnosis of chronic pain syndrome.

 

On 5/13/2025, 5/14/2025, and 5/15/2025, there was no evidence of paper documents used by the nurse for the start of care for Patient 12. There was no paper consents present at the HHA.

During an interview with the Owner (OW) on 5/13/2025, at 12:53 p.m., when the OW was asked how the HHA maintained the patients’ clinical records, the OW stated there were no paper documents in the HHA’s office for Patient 8, Patient 9, Patient 10, Patient 11, and Patient 12. The OW stated that all records were either uploaded into the electronic health records (EMR) or in her e-mail.

During an observation on 5/13/2025 at 12:54 p.m., the OW called Registered Nurse 1 (RN 1) on the cell phone and placed the call on speaker. The OW inquired about the patients’ consent forms. RN 1 told the OW that he had all the consents with him and would bring to the HHA today, 5/13/2025.

During an interview on 5/15/2025, at 10:41 a.m., RN 1 stated he brought the admission paperwork and patients consents to the office within 2 days of the start of care. RN 1 stated he gave the documents to the OW, then someone puts in in the EMR. RN 1 stated he did not know who documents into the patients’ EMR.

During an interview with the OW on 5/15/2025, at 2:55 p.m., the OW stated the plan of care (POC) for Patient 9, Patient 10, and Patient 11 was uploaded to the EMR on the evening of 5/14/2025 with the help of a consultant. The OW stated the consultant gave her the information for the POC by e-mail, which she then transcribed to the EMR of Patient 9, Patient 10, and Patient 11. The OW stated she also received help from her other friends for the POC. The OW stated the consultant was not a Registered Nurse.

A record review of the HHA’s undated document titled, Safeguarding of Medical Records, indicated that the HHA shall maintain all patient medical records in a secure, confidential, and retrievable manner. Medical records shall be protected against loss, unauthorized access, alteration, or destruction and retained in accordance with state and federal laws...Physical Safeguards: Medical records in paper form are stored in locked file cabinets or secured rooms with restricted access...Access is limited to authorized personnel only...Electronic Safeguards: Electronic Health Records (EHRs) are maintained in a secure, encrypted system with role-based access. User IDs and passwords are required for all access to electronic records.