Affinity Home Health Care Services, Inc.

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure the comprehensive assessments for six of seven patients reviewed were accurate and complete with patient’s current health status, past medical history, psychosocial, and cognitive status, which included the patient’s ability to understand and participate in his or her plan of care (Patients 1, 2, 3, 4, 5, and 6). This failure had the potential for the agency not to develop a patient centered plan of care towards the achievement of goals and measurable outcomes identified for Patients 1, 2, 3, 4, 5, and 6. 3. On July 30, 2024, Patient 3’s record was reviewed. Patient 3 was admitted to the agency with the SOC of February 20, 2023, with diagnoses which included stage 2 (two) pressure ulcers (damage to the skin and underlying tissue due to prolonged pressure) to the left and right buttocks. The comprehensive assessment dated, June 12, 2024, for the certification period from June 16, 2024, to August 12, 2024, did not include the following: - The skin condition section of Patient 3’s mental condition for pressure score risk assessment scale; - Advance Directives which indicated Patient 3’s code status, POA information, Living Will, and Funeral Arrangements Made; and - The DME. The “No” box was checked under Patient 3’s skin condition for a presence of unhealed pressure ulcer/injury at stage 2, while the wound assessment section indicated Patient 3 had stage 2 pressure ulcers to the left and right buttocks. On July 31, 2024, at 10 a.m., a home visit was conducted with LVN 2 for Patient 3 at the ALF. Patient 3 ambulated to the living room with use of a rollator (a device used to assist with walking). Patient 3 was observed to have stage 2 pressure ulcers to the left and right buttocks. On July 31, 2024, at 11:10 a.m., LVN 2 was interviewed. LVN 2 stated Patient 3 had stage 2 pressure ulcers on his left and right buttocks, and they were chronic. 4. On July 30, 2024, Patient 4’s record was reviewed. Patient 4 was admitted to the agency with the SOC date of July 3, 2024, with diagnoses which included hypertension. The comprehensive assessment dated July 8, 2024, for the certification period from July 3, 2024, to August 31, 2024, did not include the advance directives information that would indicate Patient 4’s code status, Power of Attorney information, Living Will, and Funeral Arrangements. The RN did not sign the completed comprehensive assessment. 5. On July 30, 2024, Patient 5’s record was reviewed. Patient 5 was admitted to the agency with the SOC date of July 3, 2024, with diagnoses which included hypertension (high blood pressure) and chronic obstructive pulmonary disease (a lung disease). The comprehensive assessment dated July 8, 2024, for the certification period from July 3, 2024, to August 31, 2024, did not include the advance directives information that would indicate Patient 5’s code status, Power of Attorney information, Living Will, and Funeral Arrangements. 6. On July 30, 2024, at 10:03 a.m., Patient 6’s record was reviewed. Patient 6 was admitted to the agency with the SOC date of May 11, 2023, with diagnoses which included Alzheimer’s disease (memory loss and confusion). The comprehensive assessment dated May 11, 2023, for the certification period from May 11, 2023, to July 9, 2023, did not include the advance directives information that would indicate Patient 6’s code status, POA information, Living Will, and Funeral Arrangements. The RN did not sign the completed comprehensive assessment. On August 1, 2024, at 11:20 a.m., a concurrent interview and record review was conducted with the DOPCS. The DOPCS stated she was responsible for reviewing for accuracy and completeness of the comprehensive assessment. She stated the comprehensive assessment should be accurate and complete for the formulation of the patient’s plan of care. A review of the agency’s undated policy and procedure titled, “INITIAL AND COMPREHENSIVE ASSESSMENT,” indicated “…An initial patient assessment will be performed and documented in the patient’s medical record…including the following information…The patient’s medical and psychosocial history…Presence of any Advance Directives for care or discussions with patient and, as appropriate, family/caregiver, regarding the withholding of resuscitative services or the withdrawal of life-sustaining treatment…Wishes regarding care, treatment, and end-of-life decisions…Equipment presently in the home and potentially needed by patient…Cultural and religious practices...Immunizations when appropriate…” 1. On July 30, 2024, Patient 1’s record was reviewed. Patient 1 was admitted to the agency with the Start of Care (SOC) date of July 18, 2024, with diagnoses which included open wound left lower leg. The comprehensive assessment dated July 18, 2024, for the certification period from July 18, 2024 to September 23, 2024, did not include the following: The psychosocial section of Patient 1’s educational level, spiritual/cultural implications that impact the care; The description of patient’s mental status, which included the general appearance, behaviors, emotional responses, mental functioning, and overall social interaction; The name of the Assisted Living Facility (ALF), phone number, list of contact information; The accurate functional status and abilities as observed during home visits; Advance Directives which indicate Patient 1’s Code Status (type of emergent treatment a person would and would not if their heart or breathing were to stop), Power of Attorney (POA) information Living Will, and Funeral Arrangements; Immunizations information; Prior hospitalization; Pertinent History and Others (specify); Cardiopulmonary which include breath sounds, and edema. Patient 1’s primary reason for home health service was “...patient has a cellulitis infection to her left lower extremity, which is edematous with + 3 pitting (type of edema when an indentation remains after pressing swollen skin); and The Durable Medical Equipment (DME). On July 31, 2024, at 8:30 a.m., a home visit was conducted with Licensed Vocational Nurse (LVN) 1 for Patient 1 at the Assisted Living Facility (ALF). Patient 1’s Family Member (FM) was present during the visit. Patient 1 was observed sitting in the ALF’s dining room. Patient 1 was brought in to her room by the ALF staff using a wheelchair. Patient 1 was assisted by the two ALF staff to transfer from the wheelchair to her bed. Patient 1 was alert and able to answer LVN 1’s simple questions. Patient 1 needed two ALF staff to be pulled up from the sitting position at the foot of the bed to a lying position. Patient 1’s left leg pitting edema was present, with minimal redness around the wound. Patient 1’s bathroom was observed with shower chair and high riser over the toilet seat. A walker was observed at the side of her room. On July 31, 2024, at 9 a.m., Patient 1’s FM was interviewed. The FM stated Patient 1 had blackish blisters on the middle areas of both legs. The FM stated Patient 1 was brought to the urgent care center and was hospitalized on June 6, 2024, for skin infection. The FM stated Patient 1 had received two kinds of antibiotics for the infection, and the right leg blister was healed. The FM stated Patient 1 had frequent falls and recurrent urinary tract infections that needed 24 hours care and treatment of her left leg wound. The FM stated she was not the Power of Attorney (POA) for Patient 1. She stated another FM had Patient 1’s Advance Directive and POA. 2. On July 30, 2024, Patient 2’s record was reviewed. Patient 2 was admitted to the agency with the SOC date of July 1, 2024, with diagnoses which included hypertension (high blood pressure) and urinary frequency. The initial comprehensive assessment dated July 1, 2024, for the certification period from July 1, 2024 to August 29, 2024, was reviewed. The comprehensive assessment did not include the following: The psychosocial section of Patient 2’s educational level, the spiritual/cultural implications that impacts the care; The description of Patient 2’s mental status which included the general appearance, behaviors, emotional responses, mental functioning, social interactions during visit; The name of the ALF, the phone number of ALF, list of other contact information; The Home Safety Assessment of ALF; Advance Directives which included the POA, Code Status; Immunizations’ dates; and Hospitalization Risk Assessment which included notification of appropriate persons in case of hospitalization. On July 31, 2024, at 1:30 p.m., a home visit was conducted with Registered Nurse (RN) for Patient 2 at the ALF. Patient 2 resides at the ALF alone. Patient 2 was ambulatory using her four prong cane, alert, oriented and able to verbalized her needs. Patient 2’s prescription containers were observed on top of her dining table. Patient 2 was observed with a call light device around her neck. She stated she used the device to call the ALF staff for assistance. Patient 2 stated she was at the independent living facility for three years and was transferred at the ALF on May 2024. Patient 2 stated she had seven children, and one had POA. On July 31, 2024, at 2:50 p.m., a concurrent interview, and review of Resident 2’s comprehensive assessment dated July 1, 2024, was conducted with the RN. The RN stated the initial assessment should be complete and accurate. She stated she missed to enter multiple important information in the initial comprehensive assessment for Patient 2. On August 1, 2024, at 12:02 p.m., a concurrent interview and record review was conducted with the Director of Patient Care Services (DOPCS). The DOPCS stated the comprehensive assessment of the RN was reviewed and validated by her. She stated the initial comprehensive assessment should be accurate and complete for the formulation of patient’s plan of care.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure the medications listed in patient’s current medication profile and current Plan of Care (POC) were updated, accurate, and complete for one of three patients reviewed (Patient 2). This failure had the potential for Patient 2, the Assisted Living Staff (ALF) staff, and Family Member (FM) not to be able to identify the significant drug interactions, ineffective drug therapy and non-compliance with prescribed medications. On July 30, 2024, Patient 2’s record was reviewed. Patient 2 was admitted to the agency with the Start of Care (SOC) date of July 1, 2024, with diagnoses which included hypertension (high blood pressure). The physician’s order dated July 1, 2024, indicated “...Skilled Nursing (SN) visit 3w1 (three times a week for week one) and 2w4 (two times a week for four weeks)...SN to teach / validate patient / PCG (primary care giver) signs and symptoms, risk factors...knowledge and management of medications, actions, side effects...” The medication profile dated July 1, 2024, written by the RN during the initial visit included the following: “...Lisinopril - Hydrochlorothiazide (medication used for high blood pressure) 20-25 milligram (MG - a unit of measurement) 1 tablet oral daily for hypertension...and Red Yeast Rice (a supplement) 1200 mg, 2 tabs (tablets) oral daily...” The POC and the current medication profile for the certification period from July 1, 2024 to August 29, 2024, were reviewed. The POC and the current medication profile included the medications Lisinopril - Hydrochlorothiazide 20-25 mg one tablet oral daily and the supplement Red Yeast Rice was transcribed as 600 mg 2 tabs oral daily. On July 31, 2024, at 1:30 p.m., a home visit was conducted with the RN for Patient 2 at the ALF. Patient 2 was alert, oriented, and able to verbalized her needs. Patient 2 stated she managed her own medications. On July 31, 2024, at 2:12 p.m., a concurrent medication reconciliation and interview was conducted with Patient 2 and the RN. The following medications were observed: Lisinopril- Hydrochlorothiazide, 20-12.5 mg. two tablets daily oral; Oxybutynin Chloride ER (medication used to decrease muscle spasm of the bladder and frequent urge to urinate) 5 mg. one tablet daily oral; Red Yeast Rice, 1200 mg 2 tablets daily oral; and Acetaminophen (Tylenol- used for fever or minor aches and pain) 650 mg. one tablet every eight hours. The RN stated the medications Lisinopril 20-12.5 mg two tablets daily and the Oxybutynin Chloride ER 5 mg one tablet daily were new prescriptions for Patient 2. RN 1 stated the medication profile was not updated. She stated she found out about the new medications on July 30, 2024. She stated the Physician Assistant (PA) came to the ALF on July 22, 2024, to visit Patient 2. She stated the new medications were started on July 23, 2024, and the medication profile should have been updated. The RN stated she conducted the initial assessment on July 1, 2024, and did not see the bottle of Tylenol 650 mg. She was not sure about the dosage of the Red Yeast Rice supplement. The current medication profile indicated “Red Yeast Rice 600 mg two tablets oral daily” and the bottle indicated 1200 mg. two tablets oral daily. Patient 2 stated she had taken the new medications since last week. She stated she had been taking the Red Yeast Rice 1200 mg two tablets daily for a long time. She stated she used the Tylenol 650 mg one tablet a day for her shoulder pain. The RN acknowledged the Tylenol 650 mg one tablet every eight hours was not listed in the agency’s current medication profile. The RN stated the medication reconciliation should be done on every home visits by Skilled Nurse (SN). On August 1, 2024, Patient 2’s record was reviewed. The PA’s note dated July 22, 2024, indicated a visit to ALF for Patient 2. The note indicated the following orders: “DC (discontinue) Lisinopril-HCTZ (hydrochlorothiazide) 20- 25 mg one tablet daily on 07/23/24; Lisinopril - HCTZ 20-12.5 2 tabs (tablets) by mouth once a day; and Oxybutin ER 5 mg 1 tab by mouth once a day...” On August 1, 2024, at 12:05 p.m., a concurrent interview and record review was conducted with the Director Of Patient Care Services (DOPCS), the Clinical Compliance Officer and the Care Coordinator. The DOPCS acknowledged Patient 2’s current medication profile was not updated. The DOPCS stated medication reconciliation should be conducted by the SN on every visit for all patients. On August 2, 2024, at 9:05 a.m., a concurrent interview and review of skilled nursing visit notes was conducted with the DOPCS. The notes indicated Patient 2 had LVN visits on July 23, 2024, and July 26, 2024. The DOPCS stated the notes did not indicate any change in Patient 2’s medications. She stated the LVN who visited Patient 2 on July 23, 2024 and July 26, 2024, should have asked the ALF medication technician for new physician’s orders and should have conducted the medication reconciliation. A review of the agency’s undated policy and procedure titled, “MEDICATION PROFILE / DOCUMENTATION,” indicated “...Patients receiving medications will have current, and accurate medication documentation in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications...The RN or LVN (Licensed Vocational Nurse) will inquire about medication changes each visit and record any changes...””

“In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This Element is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure patient’s high blood pressure reading and low heart rate were rechecked during Skilled Nursing visits for one of seven patient’s reviewed (Patient 2). This failure had the potential to place Patient 2 at risk for complications and not to receive the necessary care and services promptly, according to the agency’s best standard of practice. On July 30, 2024, Patient 2’s record was reviewed. Patient 2 was admitted to the agency with the Start of Care (SOC) date of July 1, 2024, with diagnoses which included hypertension (high blood pressure). The physician’s order dated July 1, 2024, indicated “...Skilled Nursing (SN) visit 3w1 (three times a week for week one) and 2w4 (two times a week for four weeks)...SN to perform vital signs (blood pressure, heart rate and respiratory rate)...SN to teach / validate patient / PCG (primary care giver) signs and symptoms, risk factors...knowledge and management of medications, actions, side effects...” The physician’s referral note dated June 26, 2024, indicated an order for “Home health for nursing BP (blood pressure) and safety...” The SN visit/progress notes from July 4, 2024 to July 26, 2024, was reviewed. The SN visit/progress note dated July 10, 2024, indicated Patient 2’s blood pressure was 195/79 and heart rate of 48. There was no documented evidence Patient 2’s blood pressure and heart rate were rechecked by SN during the visit from 10:30 a.m. to 11:10 a.m. The SN visit/progress note dated July 23, 2024, indicated Patient 2’s blood pressure was 190/85. There was no documented evidence Patient 2’s blood pressure was rechecked during the visit from 9:03 a.m. to 9:45 a.m. On July 31, 2024, at 1:30 p.m., a home visit was conducted with the RN for Patient 2 at the Assisted Living Facility. Patient 2 was alert, oriented, and able to verbalize her needs. Patient 2 was observed with multiple electronic blood pressure monitoring devices. Patient 2 showed the RN her recorded blood pressures in a small notebook. Patient 2 stated she took her blood pressure twice a day. On July 31, 2024, at 3:10 p.m., a concurrent interview and record review was conducted with the RN during the home visit for Patient 2 at the ALF. The SN visit/progress notes were reviewed. The RN acknowledged Patient 2’s blood pressures were not rechecked during the LVN visits on July 10, 2024, and July 23, 2024. She stated the LVN should have rechecked Patient 2’s blood pressure before leaving the ALF. On August 1, 2024, at 12:20 p.m., a concurrent interview and review of SN visit notes was conducted with the Director of Patient Care Services (DOPCS). The DOPCS acknowledged Patient 2’s blood pressures on July 10, 2024, and on July 23, 2024, were in high range above normal. She stated the LVN should have rechecked Patient 2’s blood pressure and heart rate before the end of the visits. She stated all SN should observed the agency’s best standard of practice. The DOPCS stated the agency will develop a policy related to the failed practice.”