My Home Care LLC

“Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This Condition is not met as evidenced by: Based on record review, document review, policy review and interview, it was determined the Home Health Agency (HHA) failed to notify the physician of missed doses of medication as ordered on the Plan of Care. The cumulative effect of this deficient practice has the potential to place patients at risk for harm due to the agency’s inability to coordinate and complete the ordered Plan of Care. Findings Include: 1. The Home Health Agency failed to coordinate patient care services by not communicating with and informing the physician of pertinent assessment findings, that included missed doses of medication, which prevented the current Plan of Care to be implemented. (Refer to G0718)”

“Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This Element is not met as evidenced by: Based on record review, document review, policy review, and staff interview, the agency failed to coordinate patient care services by not communicating with and informing the physician of pertinent assessment findings, that included missed doses of medication, which prevented the current Plan of Care (POC) to be implemented for 1 (Patient 1) of 5 sample patients reviewed. This failure places all patients at risk of adverse outcomes and potential failure to have all care needs met. Findings Include: Review of an undated agency policy titled, “Pharmacy Refills,” showed, “. . . to ensure care coordination between physician/nurse/pharmacy and patients so that patient medications are available to be administered as ordered.” The policy showed, “follow up with pharmacy if not delivered within 2 days of request,” and confirmed, “primary care provider will be notified of such missed dosage by the 2nd day of missed dose.” Patient 1 Review of Patient 1’s clinical record, “Plan of Care,” (POC) showed, a start of care date of 10/05/23 and a certification period from 07/31/24 to 09/28/24. The primary diagnosis showed, anoxic brain damage, not elsewhere classified. Orders on the POC confirmed the Skilled Nurse (SN) visit frequency as three times per day, for 60 days (3xD/60D.) Review of agency skilled visit documentation showed three skilled nursing visits completed on 09/23/24 as ordered, however the valproic acid was not administered as ordered, due lack of available medication. Review of Patient 1’s POC medications showed, “Valproic Acid (medication to prevent seizures) Oral, 250 mg/5ml, 15 ml per peg tube (tube inserted in the stomach to assist with nutrition and medication),” was ordered to be administered three times per day, but did not specify orders or instructions that indicated if agency nursing staff or residential home plus staff would administer the medication. The POC medications showed that the patient was also receiving Keppra (medication to prevent seizures) 500 mg twice a day. An untitled agency document, dated 09/20/24, showed lab work for the patient, obtained by the agency on 09/19/24 for diagnostic testing and confirmed a valproic acid level of 96.4 mg/L (Normal Range 50.0 - 100.0 mg/L.) The same document showed a Keppra level of 15.9 ug/mL (Normal Range 6.0 - 46.0 ug/mL.) During an interview on 10/29/24 at 3:00 PM, Staff A, Administrator, stated the patient lived in a residential home plus and all patient medications are given by the residential home plus medication aide except the valproic acid, which the Home Health Agency’s skilled nurses administer, three times per day, as ordered. Staff A explained that the residential home plus will not allow their medication aides to administer this medication because it required measurements in milliliters. Staff A confirmed that when the medication is running low, the SN notifies the medication aide to request a refill. Staff A explained the process of notifying the medication aide, who then notifies the pharmacy of the needed medication refill. Staff A confirmed that the pharmacy comes to the residential care home weekly to refill medications. Review of a residential home plus document titled, “Medication Administration Record (MAR),” dated 09/01/24, for the month of September, showed that the patient missed 18 doses of Valproic Acid between 09/19/24 through 09/24/24. Review of a document titled, “Refill Request Long Term Care, “ used by the residential care home to fax medication requests to pharmacy, showed that a request for the valproic acid had been faxed on 09/17/24, the same day the SN notified the medication aide of the need for a refill of the medication. There was no documentation to support the agency’s SN contacted the pharmacy to inquire about the status of the medication refill, prior to being out of the medication. There was no documentation to support the agency’s SN notified the physician that the patient was out of the medication or the missed valproic acid doses. Document review of untitled agency self-reported incident information regarding the missed medication doses, showed that Patient 1 missed doses of valproic acid on 09/20/24, 09/21/24, 09/22/24, and 09/23/24. The document showed that Staff B, Registered Nurse (RN) contacted the pharmacy on 09/23/24 at 8:36 AM, during the skilled nurse visit, to inquire about the medication refill. Staff B documented, “Out of valproic acid contacted pharmacy and they will send out later today.” The documentation showed Staff B made a visit on 09/23/24 at 5:00 PM to administer the valproic acid, however, the medication had not been delivered by the pharmacy. On 09/24/24, upon arrival to administer the morning dose of the valproic acid, Staff B found the patient was having a seizure and called 911. The patient was taken to the hospital via ambulance. Review of the same document showed the agency created a policy on missed medication doses and pharmacy refills, that included required notification of the primary provider (physician) by the 2nd day of any missed medication. The new policy required the agency to follow up with pharmacy if medication was not delivered within 2 days of request. The document included a plan for the agency to complete weekly audits of 10% of all active charts to ensure required reporting to the doctor and follow up with the pharmacy was completed. There was no documentation to support the agency completed weekly audits of active patient records to ensure the effectiveness of the agency’s corrective action plan and staff compliance with the new policy. During an interview on 10/29/24 at 4:00 PM, Staff B, Registered Nurse confirmed contact of the pharmacy on 09/23/24 to question when the valproic acid would be sent out and was told that it would be sent out that day. When questioned as to why Staff B had not contacted the pharmacy earlier, Staff B stated that the residential home plus had faxed the request to the pharmacy. During an interview on 10/30/24 at 10:30 AM, Staff A, Administrator, stated that due to this incident, the agency had developed a policy, which previously the agency had not had in place, titled, “Pharmacy Refills.” Staff A confirmed the agency failed to communicate with the physician related to the missed doses of valproic acid, ordered on the plan of care, prior to the patient having a seizure. Staff A confirmed the patient missed three doses of valproic acid, per day, from 09/19/24 through 09/24/24. Staff A confirmed skilled nursing visits continued three times per day during that time, to monitor the patient, the patient’s blood sugars and to administer insulin as ordered.”