Every finding on record at Sharon Home Care Services LLC

Based on the findings of an onsite unannounced Medicare recertification survey completed April 18, 2024, Sharon Regional Health System Home Health was found to be in compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies – Emergency Preparedness.

Based on the findings of an onsite unannounced Medicare recertification survey completed April 18, 2024, Sharon Regional Health System Home Health was found not to be in compliance with the following requirement(s) of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

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 review of clinical records (CR), agency policy, and staff (EMP), the agency failed to ensure the comprehensive assessment included a review of all medications the patient was 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 for one (1) of two (2) clinical records with a venous access device (CR8). Findings included: Review of agency policy on April 18, 2024, at 12:40 p.m., "MONITORING MEDICATIONS ... PURPOSE: To provide a process to ensure continuous monitoring of medications in the patient's home ... POLICY: A drug regimen review will be performed on all patients in conjunction with all comprehensive assessments. Additionally, all clinicians will participate in medication review and reconciliation throughout the episode. ... PROCEDURE: 1. The discipline responsible for the drug regimen review will: a. Compare medication list obtained from the facility from which the patient was transferred and/or physician orders to actual medications patient is taking ... b. Review all medications including over the counter (OTC) medications, vitamins, herbs and herbal products, creams and topical ointments, and medical marijuana ... to identify issues such as: i. Potential adverse effects and drug reactions; ii. Ineffective drug therapy; iii. Significant side effects; iv. Drug allergies; v. Contraindicated medications ... 4. The completed medication list will be provided and communicated to any authorized service provider ... The agency will provide the patient or the transferring or accepting organization a complete reconciled medication list upon discharge or transfer." Review of agency policy on April 18, 2024, at 12:45 p.m., "PATIENT ASSESSMENT, INITIAL AND REASSESSMENT ... PURPOSE: To describe the process of patient assessments POLICY: All patients admitted to the agency will receive an initial assessment ... PROCEDURE: 1. Upon admission and reassessments, the qualified clinician performs the following assessment activities and collects the following data: ... e. Review of all medications patient is currently using in order to identify any potential adverse effects and drug reactions." Review of CR8 on April 16, 2024, at 12:30 p.m. showed the registered nurse completed the comprehensive reassessment on 2/12/2024. The physician ordered plan of care showed the patient was recertified from 2/17/2024 to 4/16/2024. Orders included skilled nursing (SN) to see the patient once a week for lab draws via patient's Mediport (venous access device) every visit using 10 milliliters (ml) of normal saline (a medication) and 5 milliliters of heparin (a medication that prolongs the time it takes blood to clot), "FLUSH WITH 10 ML NORMAL SALINE and 5ML of HEPARIN AFTER SPECIMEN DRAW." The patient received skilled nursing visits on the following dates for lab draws when his/her Mediport was flushed with normal saline and heparin: 2/19, 2/26, 3/4, 3/11, 3/25, 4/8, and 4/15/2024. A review of CR8's medication list did not show that normal saline or heparin had been reconciled to check for significant side effects, significant drug interactions, or duplicate drug therapy. Interview with EMP1 (administrator), and EMP2 (clinical manager) on April 18, 2024, at 11:30 a.m. confirmed findings. During a phone interview with EMP10 (home health survey and performance improvement manager) on April 18, 2024, at 12 p.m. he/she asserted that normal saline and heparin are not required to be reconciled on the medication list because the FDA (food and drug administration) no longer considers them medications. According to the National Institute of Health (NIH), reviewed on April 18, 2024, at 3:30 p.m., heparin can cause a potentially fatal condition known as heparin-induced thrombocytopenia (HIT), "NIH National Library of Medicine ... Last Update: May 16, 2023 ... Heparin-Induced Thrombocytopenia ... Heparin-induced thrombocytopenia (HIT) is a severe complication that can occur in patients exposed to any form or amount of heparin products. A fall in platelet counts and a hypercoagulable state characterize HIT. Patients who experience HIT may also develop thromboembolic complications [when a blood clot forms and travels to a different part of the body that can cause a stroke etc.] that are associated with significant morbidity and mortality. This is a significant burden since heparin is widely used for treatment and prophylaxis of thromboembolism, line flushes, and heparin-coated catheters." Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK482330/

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on review of clinical records (CR), agency policy, and staff (EMP) interview, the agency failed to ensure the patient's plan of care was reviewed as frequently as the patient's needs require for two (2) of 13 clinical records (CR5, & CR7). Findings included: Review of agency policy on April 18, 2024, at 12:30 p.m. "COORDINATION OF CARE, FROM ADMIT THROUGH DISCHARGE ... 4. Coordination of care with physician/authorized practitioner: ... throughout care, ... coordination of services is promoted though routine communication with the patient's physician: ... e. When there is need to change the patient's plan of care. PAIN ASSESSMENT ... POLICY: ... A score of 7 or greater on any of the pain assessment tools ... is indicative of severe pain, which will require physician/authorized practitioner notification and patient appropriate interventions." Review of CR5 on April 16, 2024, at 9:30 a.m. showed a physician ordered plan of care with a recertification period from 2/25/2024 to 4/24/2024. Orders included skilled nursing to see the patient for assessment to include, "Skilled nurse to monitor pain." Goals included, "Pain control ... pain levels to be reduced from 8/10 to 5/10 [0-10 scale where 10 is severe pain] by March 9." Review of three (3) consecutive skilled nursing notes from 3/12, 3/20, and 4/10/2024 showed patient's pain was an 8/10. There was no revision to the plan of care to meet the needs of the patient per listed goal. Interview with EMP1 (administrator) and EMP2 (clinical manager) on April 18, 2024, at 10:55 a.m. confirmed findings. Review of CR7 on April 16, 2024, at 10:20 a.m. showed a physician ordered plan of care with an initial certification period from 3/11/2024 to 5/9/2024. Orders included skilled nursing to see the patient for assessment to include, "Skilled nurse to monitor pain." A review of the initial comprehensive assessment completed by the registered nurse on 3/11/2024 showed the patient's pain was rated at an 8/10. The next skilled nursing visit on 3/18/2024 completed by the licensed practical nurse (LPN) showed the patient's pain was an 8/10. The next skilled nursing visit on 3/25/2024 completed by the LPN showed the patient's pain was 8/10. There was no revision to the plan of care to meet the needs of the patient until a subsequent visit on 3/28/2024 when the physical therapist documented, "Pain not improved and is constant Lightheaded after bowel movement ... No appetite ... Can't sleep. Unable to reach [attending physician] via phone requested fax be sent urgent with update on patient status after discussion with [EMP1]." Per agency note from 4/1/2024, the patient was transferred to an inpatient unit for pain management. Interview with EMP1 and EMP2 on April 18, 2024, at 11:15 a.m. confirmed no revision to the plan of care until 3/28/2024 (17 days after the completion of the initial comprehensive assessment).

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on review of clinical records (CR), agency policy, and staff (EMP) interview, the agency failed to alert the physician to changes in the patient's condition that suggest that the plan of care should be altered for two (2) of 13 records (CR1, & CR3). Findings included: "COORDINATION OF CARE, FROM ADMIT THROUGH DISCHARGE ... 4. Coordination of care with physician/authorized practitioner: ... a. When a change occurs in the patient's condition or response to treatment. ... 8. Coordination of Care for Updates to the Plan of Care: a. Revisions to the plan of care due to a change in the patient's condition will be communicated to: ... iv. All physicians ... issuing orders ... The responsible [attending/certifying] physician ... will be notified of orders from other physicians." Review of CR1 on April 16, 2024, at 12:30 p.m. showed a physician ordered plan of care with an initial certification period from 2/17/2024 to 4/16/2024. Orders included skilled nursing to see the patient for wound care once a week. On 3/22/2024, the registered nurse documented, "Left 4th toe is black hard eschar around entire toe ... recommended ER [emergency room] eval today and both [patient and daughter] verbalized understanding ... Did call wound center to report black toe." Per agency note from 3/25/2024, the patient was admitted to the hospital for wound deterioration after the 3/22/2024 visit. Interview with EMP1 (administrator) and EMP2 (clinical manager) on April 18, 2024, at 10:30 a.m. confirmed findings and that CR1's attendings (physician who certified the plan of care for home health) was not notified and that the attending is not associated with the wound center. Review of CR3 on April 16, 2024, at 8:07 a.m. showed a physician ordered plan of care with an initial certification period from 2/17/2024 to 4/16/2024. Orders included skilled nursing to see the patient for care and assessment related to cardiac complications. On 3/11/2024, the licensed practical nurse documented, "CG [caregiver] reports patient has had a steady decline. Overall decrease in strength. Patient has not been able to get up to use BR [bathroom]. Patient has been using urinal when possible. Patient has been having frequent incontinence episodes of bowel. ... CG [...] called PCP [primary care physician] and VA about decline prior to visit. Due to episodes of tachypnea [fast respirations] with mobility educated patient and CG on importance of seeking ER [treatment] if symptoms worsen." Interview with EMP1 and EMP2 on April 18, 2024, at 10:51 a.m. confirmed findings and that there was no documentation to show the LPN notified CR3's attendings concerning patient's decline (change in condition).

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on review of agency policy, documentation during home visits, and staff (EMP) interview, the agency failed to provide the patient and or caregiver with a visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA; patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA; and any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services for three (3) of three (3) home visits of patients who had a completed comprehensive assessment and physician approved plan of care (CR9, CR10, & CR12). Findings included: Review of agency policy on April 18, 2024, at 12:30 p.m., "COORDINATION OF CARE, FROM ADMIT THROUGH DISCHARGE ... 7. Coordination of care with the patient and caregiver: Written information obtained from the plan of care will be provided to the patient and caregiver outlining: a. a visit schedule including frequency of visits by agency staff and contract workers b. Medication schedule/instructions including: medication name, dosage and frequency, and which medications will be administered by agency staff and/or contract workers c. Treatments to be administered by staff or contract workers, including therapy services d. Pertinent instructions related to the patient's care and treatments that the agency will provide, specific to the patient's need." Review of CR9 on April 16, 2024, at 3 p.m. showed a physician ordered plan of care with an initial certification period from 4/6/2024 to 6/4/2024. The patient's comprehensive assessment was completed on 4/6/2024 by the registered nurse (RN). The patient's diagnosis was aftercare following joint replacement. The physician approved the plan of care on 4/7/2024 with orders for weekly skilled nursing (SN) visits to assess and educate patient concerning medications and when CR9's staples were to be removed. Physical therapy (PT) was to see the patient three times per week for therapeutic exercise. Review of CR9's patient information packet/folder during a home visit on April 17, 2024, at 8:30 a.m. with EMP1 (administrator) and CR9's wife revealed the patient had not received written information from the agency concerning visit schedule, medication schedule, and treatments or other pertinent instructions related to the patient's care. Further review of CR9 on April 18, 2024, at 12:30 p.m. showed the patient received SN services on 4/6, and 4/11/2024; and physical therapy (PT) services on 4/7, 4/10, 4/15, and 4/17/2024. Review of CR10 on April 16, 2024, at 3:15 p.m. showed a physician ordered plan of care with an initial certification period from 4/6/2024 to 6/4/2024. The patient's comprehensive assessment was completed on 4/6/2024 by the RN. The patient's admitting diagnosis was Parkinson's disease. The physician approved the plan of care on 4/7/2024 with orders for skilled nursing to provide wound care, and education concerning the disease process and his/her medications. PT and occupational therapy (OT) were to provide therapeutic exercises twice a week. Review of CR10's patient information packet/folder during a home visit on April 17, 2024, at 10 a.m. with EMP1 revealed the patient had not received written information from the agency concerning medication schedule, or information concerning treatments or other pertinent instructions related to the patient's care. Further review of CR10 on April 18, 2024, at 12:45 p.m. showed the patient received SN services on 4/6, and 4/8, and 4/17/2024; PT services on 4/10, 4/10 and 4/15; and OT services and 4/10, and 4/16/2024. Review of CR12 on April 16, 2024, at 3:30 p.m. showed a physician ordered plan of care with an initial certification period from 3/29/2024 to 6/4/2024. The patient's comprehensive assessment was completed on 3/29/2024 by the RN. CR12's admitting diagnosis was stroke. The physician approved the plan of care on 3/31/2024 with orders for skilled nursing once a week to provide care and assessment related to medications and disease process, wound care, and education concerning the disease process and his/her medications; PT/OT 1-2 times per week to provide therapeutic exercise; and speech therapy (ST) weekly for evaluation and assessment. Review of CR12's patient information packet/folder during a home visit on April 17, 2024, at 2 p.m. with EMP1 revealed the patient had not received written information from the agency concerning visit schedule, medication schedule, or information concerning treatments or other pertinent instructions related to the patient's care. Further review of CR12 on April 18, 2024, at 12:55 p.m. showed the patient received SN services on 3/29, 4/5, 4/9, and 4/16/2024; PT services on 4/1, 4/4 and 4/8, 4/11, and 4/17; OT services and 4/2, 4/12, and 4/17/2024; and ST on 4/2, 4/9, 4/11, and 4/16/2024. Interview with EMP1 during home visits on April 17, 2024, and again on April 18, 2024, at 1 p.m. confirmed above findings.