Intense Home Health Inc.

“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 place of residence) failed to ensure one of seven sampled patients (Patient 1) plan of care was followed as ordered. This deficient practice resulted in the physician not being aware of the missed services to the patient by the HHA and the patients not receiving their ordered treatments. During a record review of Patient 1’s Home Health Certification and Plan of Care for certification period 5/30/2025 to 7/28/2025, indicated a primary diagnosis of Poly osteoarthritis (multiple joints get stiff, causing pain and/or discomfort). During a concurrent interview and record review on 7/3/2025, at 2:21 p.m., the Director of Patient Care Services (DPCS) reviewed the skilled nursing visit notes for 6/2/2025, 6/6/2025, 6/10/2025, 6/14/2025, 6/17/2025, 6/24/2025, 7/1/2025, and the plan of care (POC), for certification period 5/30/2025 to 7/28/2025. The DPCS stated Patient 1 was receiving HHA services for pain management and medication teaching. The DPCS reviewed the nursing visit notes and stated Patient 1 did not receive pain management education during her visits. The DPCS stated the POC indicted medication and disease management, but the nurse visits did not indicate that Patient 1 received medication management education. The DPCS stated the importance of pain management education was to prevent overdose of medication, prevent organ failure by not taking too much or too little medication. Patients can have other complications depending on the medication being taken. Medication management teaching was very important. During a record review of the HHA’s undated document titled, Plan of Care, the document indicated, “The care will be provided in compliance with the therapeutic and diagnostic orders and accepted standards and practice”.”

“Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This Standard is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure patient health records were safeguarded for seven of seven sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 5, Patient 6, and Patient 7). This failure resulted in an unqualified and unknown person had access to patients’ confidential clinical records. During a general observation of nursing visit notes on 7/2/2025, at 12 p.m., it was observed that the notes were typed and manually signed by a nurse with a date and time. During an interview on 7/2/2025, at 12 p.m., the Office Manager 1 (OM 1) stated the HHA did not have an electronic medical record (EMR). The OM 1 stated all the nursing visit notes were written and placed in the patient’s chart. During an interview on 7/7/2025, at 12:05 p.m., Licensed Vocational Nurse 1 (LVN 1) stated she used a template using Word (a type of computer software) on her personal computer for nursing visit notes. LVN 1 stated she typed her notes using a keyboard on her computer, which she would print, manually sign and turn into the office. During an interview on 7/7/2025, at 12:28 p.m., Licensed Vocational Nurse 3 (LVN 3) stated she used a template, obtained from the HHA, on her personal computer for nursing visit notes. LVN 3 stated she printed and signed the notes and turned them in to the HHA. During an interview on 7/7/2025, at 1:42 p.m., the Director of Patient Care Services (DPCS) stated she agreed that personal computers may not be safeguarded against hacking or unauthorized use. However, other health care organizations have had their EMR hacked, so it can happen with any computer system. During a concurrent interview and record review on 7/7/2025, at 1:58 p.m., the OM 1 reviewed the agencies document titled, “Electronic Clinical Documentation Submission”, dated 1/5/2025. The record indicated, “All patient visit notes, and other required clinical documentation must be completed and submitted electronically in the agency’s EMR Synergy…This includes but is not limited to: Skilled Nursing Visit Notes…All documentation must be submitted through the agency’s designated Synergy platform. Paper or handwritten notes are not accepted unless under pre-approved emergency circumstances.” OM 1 stated the policy did not apply because the HHA never went EMR. The policy was in place in case the agency adopts an EMR system. OW 1 stated, “we are in a grey area right now”. During an observation on 7/2/2025 at 10 a.m. at the HHA, three females and one male were noted in the agency. The females introduced themselves as the Office Manager (OM1), the Director of Patient Care Services (DPCS), and the office worker 2 (OW2). During a concurrent observation, interview, and record review, on 7/2/2025 at 12:45 p.m. in the HHA with the DPCS and OW2 of Patient 5 and Patient 6’s medical records, the DPCS was requested to provide copies of Patient 5 and Patient 6’s plan of care, medication list, and most current comprehensive nursing assessment. The DPCS handed Patient 5 and Patient 6’s medical records to OW2. The OW2 opened and started looking in Patient 5 and Patient 6’s medical records for the requested documents. OW2 was asked her position/title in the HHA. OW2 stated she did not work at the HHA and that she (OW2) was there to help out only. During an interview on 7/2/2025 at 12:50 p.m., with OM1 stated that OW2 was hired on 7/2/2025. OM1 stated that the HHA hired OW2 on 7/2/2025 because OW2 was familiar with their computer system. OW2’s employee file was requested. The DPCS and the OM1 stated that OW2 did not have an employee file because she (OW2) was just hired. OW2’s employment application was requested. The DPCS and the OM1 stated OW2 did not fill out an employment application. During an interview on 7/2/2025 at 1:34 p.m., with OW2 stated she did not fill out an HHA employment application or discussed her pay thus far with the DPCS or OM1. OW2 stated OM1 called her to ask for her help with the survey. OW2 stated she logged into the HHA computer system with the log in information provided by OM1. OW2 stated she (OW2) did not know whose log in information she was using. During a record review of the HHA’s undated document titled “Safeguarding/Retrieval of Clinical/Service Record” undated indicated “only authorized personnel will have access.” During a record review of the HHA’s undated document titled “Clinical/Services Data Collection”, indicated “Entries to the clinical/service record will be made only by organization personnel and/or by contract personnel who have a written agreement with the organization.””

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to review and document all the medications the patient was currently using for two of seven sample patients (Patient 5, and Patient 7). This deficient practice placed the patients at risk of drug-to-drug interaction and harm by not knowing which medications the patients were taking. 1. During a record review of Patient 5’s medical record form titled “Home Health Certification and Plan of Care” dated from 5/7/2025 to 7/5/2025, indicated a start of care date of 3/8/2025 with a primary diagnosis of other intervertebral disc degeneration. The Home Health Certification and Plan of Care form also indicated Skilled Nurse (SN) were to visit 1wk1 (once a week for one week), 2wk1, and 1wk7. SN to continue to perform every visit: 3. Assess/monitor for medications effectiveness, possible adverse effects, and medication duplications. During a record review of Patient 5’s medical record form titled “Drug Regimen Review” dated 5/3/2025, indicated Meloxicam and Aspirin were being taken once a day. During a concurrent interview and record review on 7/3/2025 at 9 a.m., with Patient 5’s medical record form titled “Drug Regimen Review” dated 5/3/2025, Patient 5 stated she has not taken Meloxicam for about 10 days. Patient 5 stated she takes Aspirin EC (enteric coated – does not dissolve in the stomach). Patient 5 stated she (Patient 5) used medication patch for pain to the right lower back. During a concurrent interview and record review on 7/3/2025 at 9 a.m., with License Vocational Nurse 2 (LVN2) of Patient 5’s medication labels indicated, Patient 5’s Aspirin medication label did not indicate the Aspirin was EC. The Aspirin label did not indicate the route, dose, or frequency. LVN2 stated she did not realize Patient 5’s Aspirin medication bottle label did not indicate the route, dose, or frequency. LVN2 stated the medication labels should have all the components for patient safety reasons. LVN2 was not observed asking Patient 5 for any information regarding Patient 5’s pain patch medication. LVN2 stated it was important to list all Patient 5’s medications to prevent medication errors and for safety. LVN2 stated she did not know if Patient 5 had any expired medications. LVN2 stated if Patient 5 takes expired medication the medication will not be effective. 2. During a record review of Patient 7’s medical record form titled “Home Health Certification and Plan of Care” dated from 4/15/2025 to 6/13/2025, indicated a start of care date of 4/15/2025 with a primary diagnosis of cervicalgia (neck discomfort). The Home Health Certification and Plan of Care form also indicated Skilled Nurse (SN) was to visit 2W2 (twice a week for two weeks), and 1W7. SN to continue skilled observation and assessment on all body systems with emphasis on medication compliance and effectiveness. During a record review of Patient 7’s medical record form titled “Drug Regimen Review” dated 4/15/2025, indicated Patient 7 was taking six different medications. The Drug Regimen Review also indicated there was no diagnosis or classifications listed for each medication. During a concurrent interview and record review on 7/7/2025 at 2 p.m., with the Director of Patient Care Services (DPCS) of Patient 7’s medical record form titled “Drug Regimen Review” dated 4/15/2025, the DPCS stated Patient 7’s medication list was not complete because it was missing the medication classifications. The DPCS stated each medication should list their classifications for the patient to know what the medications are for. The DPCS provided an example, as follows. The DPCS stated that Metoprolol (high blood pressure medication) and Meclizine (dizziness medication), both start with an M. If a patient does not know what either medication is for, they can mistakenly take the blood pressure medication thinking it was for dizziness, the patient can have low blood pressure, which may cause hospitalization. During a record review of the HHA’s undated document titled “Medication Reconciliation” the Medication Reconciliation form indicated “Medication reconciliation should be completed at every skilled visit and any changes should be documented both in the home medication profile and in the MD order.” During a record review of the HHA’s undated document titled “Medication Reconciliation”, the Medication Reconciliation form indicated “The admitting nurse will initiate a medication profile to document the current mediation regimen, including name dose, strength, route, frequency, date and time of administration and a diagnosis, condition, or indication for use for each medication ordered.””

“Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s internal policies. (4) When services are provided on the basis of a physician or allowed practitioner’s verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA’s policies, must document the orders in the patient’s clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA’s internal policies. This Element is not met as evidenced by: Based on interview and record review the Home Health Facility (HHA) staff failed to ensure there was physician’s order to perform wound care treatment for one of seven sampled patients (Patient 4). This failure resulted in HHA staff performing wound care treatment to the patient’s wound without a physician’s order. During a record review of Patient 4’s Home Health Certification and Plan of Care for certification period 7/11/2024 to 9/8/2024, indicated a primary diagnosis of chronic venous hypertension (high blood pressure in the leg veins). During an interview on 7/7/2025, at 12:19 p.m., Patient 4’s caregiver (CGV 1) stated Patient 4 received nursing services for wound care to the right ankle. During a concurrent interview and record review on 7/7/2025, at 12:45 p.m., the Director of Patient Care Services (DPCS) reviewed Patient 4’s medical records., to include the plan of care (POC) for certification period 7/11/2024 to 9/8/2024, and the nursing visit notes. The DPCS stated wound care was done to Patient 4’s right ankle on the nursing visit of 7/14/2024. The DPCS stated there was no physician’s order for wound care. A physician’s order was important because the order validates what needs to be assessed and what treatment the patient needs. During a record review of the HHA’s undated document titled, Plan of Care, the document indicated, “The attending physician (or other authorized licensed independent practitioner) will participate in the care planning process by initiating, reviewing and revising therapeutic and diagnostic orders...Physician, dentist, podiatrist or any other licensed practitioner within his or her scope of practice orders will be individualized, based on patient’s needs and include...B. Treatments and/or procedures needed, included type, frequency, duration, and goals.””

“Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This Element is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure a contracted agency who provided patient care communicated concerns and a change of condition for one of seven sampled Patients (Patient 4). This failure resulted in the HHA staff performing wound care without consultation of the Podiatrist (a doctor who specialized in feet). During a record review of Patient 4’s Home Health Certification and Plan of Care, for certification period 7/11/2024 to 9/8/2024, indicated a primary diagnosis of chronic venous hypertension (high blood pressure in the leg veins). During an interview on 7/7/2025, at 12:19 p.m., Patient 4’s caregiver (CGV 1) stated Patient 4 received nursing services for wound care to the right ankle. During a concurrent interview and record review on 7/7/2025, at 12:45 p.m., the Director of Patient Care Services (DPCS) reviewed Patient 4’s medical records., to include the plan of care (POC) for certification period 7/11/2024 to 9/8/2024, and the nursing visit notes. The DPCS stated wound care was done to Patient 4’s right ankle on the nursing visit of 7/14/2024. The DPCS stated there was no doctor’s order for wound care. A doctor’s order was important because the order validates what needs to be assessed and what treatment the patient needs. During a concurrent interview and record review on 7/7/2025, at 1:06 p.m., the DPCS reviewed Patient 4’s record titled, Comprehensive Adult Nursing Assessment”, dated 7/11/2023. The record indicated, “MD (doctor) ordered HHC (Home Health Agency) to await orders for wound care from DPM” (Podiatrist-foot doctor). The DPCS stated the HHA was supposed to coordinate with the DPM regarding wound care orders. The DPCS stated there was no coordination notes or doctor’s order for wound care. During a record review of the HHA’s undated document titled, Plan of Care, the document indicated, “12...All other physicians...should be made aware of the services being provided to the patient. The referring physician will be informed of the involvement of additional consulting physicians, when applicable.””

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on interviews and record review the Home Health Agency (HHA) failed to ensure clinical records included clinical nursing notes needed to accurately reflect the care for one of seven sampled patients (Patient 6). This failure resulted in an incomplete clinical record. On 7/2/2025 at 12:45 p.m., Patient 6’s current plan of care, medication list, and recertification nursing assessment were requested and provided by the Director of Patient Care Services (DPCS). During a record review of Patient 6’s medical record form titled “Home Health Certification and Plan of Care” dated from 4/18/2025 to 6/16/2025, indicated a start of care date of 2/17/2025 with a primary diagnosis of diabetes type II (high blood sugar). During a record review of Patient 6’s medical record form titled “Drug Regimen Review” dated 4/14/2025, indicated list was documented on 4/14/2025. During a record review of Patient 6’s medical record form titled “Recertification/Follow-Up Assessment” dated 4/14/2025, indicated Patient 6 was assessed and deemed eligible for home health services on 4/14/2025. During a concurrent observation and interview on 7/7/2025 at 12:15 p.m., with Office Manager (OM1) of Patient 6’s medical records, OM1 was requested to provide Patient 6’s current plan of care, medication list, and recertification nursing assessment. OM1 was observed taking Patient 6’s recertification nursing assessment and medication list out of a black cardboard box. OM1 stated that visiting nurses document their visit notes on their computers. Then when they go to the agency the nurses print and turn in their visit notes. The notes are placed inside the black cardboard box waiting to be transcribed. OM1 stated she then transcribes the nurses’ notes into their computer system, prints them out, then files the notes into the patient’s medical record. OW1 stated that Patient 6’s recertification nursing assessment, medication list, and plan of care should have been placed in Patient 6’s medical record seven days after it was completed, by 6/21/2205. During a concurrent interview and record review on 7/7/2025 at 2 p.m., with the Director of Patient Care Services (DPCS) of Patient 6’s medical record, the DPCS stated Patient 6’s medical record did not have her (Patient 6) plan of care or recertification nursing assessment. The DPCS stated Patient 6’s plan of care or recertification nursing assessment should have been placed in her (Patient 6) medical record within 7 days of the assessment, by 6/21/2025. The DPCS stated that it was important to have patients’ medical records complete and current because the medical record holds the most current physician orders, and the nurses need to follow the physician orders. The DPCS also stated that the medical record, particularly the recertification nursing assessment, will indicate what the patient needs are. During a record review of the HHA’s undated document titled “Clinical/Services Data Collection”, indicated “A clinical record… will include at a minimum: C. physician orders… D. Changes in the plan of care. F. Patient response to care and services… I. Current patient status and progress toward goals.” The Clinical/Services Data Collection form also indicated “Entries into the clinical/services record will be made on the day are/services is provided to the patient. All documentation will be turned into the office at the end of the workday.””