Every finding on record at Astra Health Care Inc

A complaint survey prompted by #CO27424, #CO27435, #CO27436, #CO27465, and #CO27487 was completed on 6/28/21. Interview and record review revealed the agency failed to provide Soliris (a time sensitive medication used to prevent the destruction of red blood cells) via intravenous (IV) infusion as ordered by the physician every 12 days and coordinate with the physician for two patients, resulting in the one patient administering his own infusion three days late and another patient not receiving services following a hospitalization. On 6/22/21 at 12:25 p.m. the agency was advised these failures created an immediate jeopardy situation for all patients being served by the agency and the agency was directed to compose a plan to immediately address the provision of services as ordered by the physician and coordination with the physician regarding the provision of services. On 6/24/21 at 2:46 p.m. the agency submitted a final plan to address the immediate jeopardy situation. According to the plan, the agency would review all patient records specific to the provision of care as ordered by the physician and coordination with the physician. A spreadsheet was developed to monitor all patients receiving time sensitive care and was monitored twice daily. The agency updated its missed visit policy and created a new discharge checklist to ensure proper coordination. All staff were trained and educated on the agency's new processes and procedures. On 6/28/21 at 12:27 p.m. implementation of the agency's plan was evaluated and at 3:58 p.m. the agency was advised the circumstances of the immediate jeopardy were removed. However, deficient practice with Condition level findings remained. One Condition level deficiency was cited: 484.60 - Care Planning, Coordination, Quality of Care Additionally, three Standard level deficiencies were cited. Refer to CFR 484.36(a)(2)(i) guidelines. An agency, which has a Condition of Participation out of compliance with any of the requirements, is precluded from conducting (if approved) or applying to conduct a Nurse Aide Training Program or Competency evaluation for two (2) years from the exit date.

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 the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation 484.60, CARE PLANNING, COORDINATION, QUALITY OF CARE was out of compliance. A total of 28 clinical records and a focus sample of 4 records were reviewed for compliance with the Condition and Standards for Care Planning, Coordination and Quality of Care. Interview and record review revealed the agency failed to provide care as ordered by the physician and coordinate care with the physician for 2 of 6 patients receiving intravenous (IV) care. These failures resulted in one patient administering his own time sensitive medication infusion three days late and another patient discharging from a hospitalization without services in place. The following standard level deficiencies were also cited. G572 - Standard: Plan of Care - The agency failed to ensure each patient received home health services in accordance with the written plan of care established and periodically reviewed by a physician for 1 of 6 patients reviewed who received skilled nursing (SN) for IV care (Patient #7). G602 - Standard: Communication with all Physicians - The agency failed to coordinate care with the physician in order to meet the needs of the patient for 2 of 6 patients reviewed who received SN for IV care (Patients #6 and #7). G608 - Standard: Coordinate Care Delivery - The agency failed to coordinate care delivery with the patient and involve the patient, representative and caregiver in the coordination of care activities in order to meet the needs of the patient for 2 of 6 patients reviewed who received SN for IV care (Patients #6 and #7).

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 agency failed to ensure each patient received home health services in accordance with the written plan of care established and periodically reviewed by a physician for 1 of 6 patients reviewed who received skilled nursing (SN) for intravenous (IV) care (Patient #7). Findings included: 1. The clinical record for Patient #7 was reviewed on 6/18/21. The Plan of Care for the certification period dated 4/15/21 to 6/13/21 revealed a start of care date of 4/15/21; diagnoses included paroxysmal nocturnal hemoglobinuria (PNH),autoimmune hemolytic anemia, acute embolism and thrombosis, chronic obstructive pulmonary disease, pulmonary embolism, long term use of anticoagulants and dependence on supplemental oxygen. Plan of Care orders included SN visits every twelve days for eculizumab (Soliris) 900 mg IV infusion. a) The agency failed to provide Patient #7's Soliris infusion every 12 days as outlined on the physician ordered Plan of Care. During an interview on 6/24/21 at approximately 1:15 p.m., Patient #7 reported he was diagnosed with PNH which requires Soliris 900 mg intravenously every twelve days for anticoagulation. He reported that in 2005-2007 he participated in an Soliris clinical trial at Stanford University. During the trial he experienced episodes of hemolysis (the destruction of red blood cells) on day 13 or 14 after the Soliris infusion. Stanford University obtained Federal Drug Administration (FDA) approval for Patient #7 to receive Soliris infusion every twelve days instead of the manufacturer's recommended fourteen day regimen due to the increased risk of blood clots, hospitalization or death. Continued interview revealed, Patient #7 reported on 6/13/21 Nurse #7 came to his home to complete a recertification assessment. Patient #7 reported Nurse #7 was at his home for approximately ten minutes and only took his blood pressure, pulse oximetry and asked if he was on any medications. Patient #7 reported that the nurse did not inquire about names, doses or times of medications. The nurse told Patient #7, a nurse would call before the scheduled 6/14/21 infusion, however, a nurse did not call or come to his home for care on 6/14/21. Continued interview revealed, Patient #7 reported the agency called him on 6/14/21 at 2:49 p.m., to schedule the infusion for 6/15/21 at 10:00 a.m. He stated no nurse came to his home as scheduled for the infusion on 6/15/21. Patient #7 called the agency at 4:00 p.m. and was told the nurse had an emergency. There was no infusion on 6/15/21 and the visit was not rescheduled. Further interview revealed, Patient #7 reported he had the Soliris medication and infusion supplies in his home. On 6/17/21 a family member assisted Patient #7 with the infusion, three days after the scheduled dose was to be administered by the agency nurse. The clinical record for Patient #7 revealed an original start of care date of 2/14/21. Review of SN visit notes revealed completed nursing visits with the provision of the Soliris infusion on 2/14, 2/26, 3/10, 3/22, 4/3, 4/15, 4/27, 5/9, 5/21 and 6/2/21. A SN visit was completed on 6/13/21 for recertification; however, no Soliris infusion was provided at the 6/13/21 nursing visit. The next nursing visit was scheduled for 6/14/21. Review of a communication note dated 6/14/21 signed by the Director of Clinical Services (DCS) revealed a missed nursing visit on 6/14/21 and a new visit scheduled for 6/15/21 at 10:00 a.m. There was no evidence the agency had coordinated care with Patient #7's physician. Review of an agency communication note dated 6/15/21 revealed Patient #7 called the agency at 4:30 p.m. reporting the nurse had not been to the home to administer the infusion. The note stated the DCS drove to Patient #7's home to provide the service but he was not there. Record review failed to reveal further attempts to schedule the infusion. There was no evidence the agency had coordinated care with Patient #7's physician. During an interview with the DCS on 6/18/21 at approximately 3:15 p.m., the DCS stated the regular nurse (Nurse #3) was suspended on 6/10/21 and terminated employment with the agency on 6/14/21. Nurse #3's termination of employment resulted in changes in staffing Patient #7's infusion. Continued interview revealed, the DCS stated she went to Patient #7's home the evening of 6/15/21 but the patient did not answer the door and she was unable to communicate with him regarding his care. As of 6/18/21, the DCS was not sure if Patient #7 had received the eculizumab infusion. Review of email communication to Patient #7 from the Agency Administrator on 6/21/21 at 3:56 p.m., seven days after the scheduled infusion, stated that the nurse scheduled on 6/14/21 was "very distraught" due to a "critical family emergency" and was unable to provide care as scheduled. The email further read " we contacted your doctor and per your MD you did not receive your IV infusion in their office. You definitely need your infusion as soon as possible". Review of agency communication notes failed to reveal any communication with Patient #7's physician to discuss how to proceed with patient care regarding missed time sensitive medication administration.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to coordinate care with the physician in order to meet the needs of the patient for 2 of 6 patients reviewed who received skilled nursing (SN) for intravenous (IV) care (Patients #6 and #7). Findings include: 1. The clinical record for pediatric Patient #6 was reviewed on 6/18/21. The Plan of Care for the certification dated 4/21 through 6/19/21 revealed a start of care date of 12/22/20; diagnoses included preterm newborn-29 weeks gestational, gastrostomy, intestinal malabsorption, moderate protein malnutrition and chronic respiratory disease. Plan of Care orders included SN visits one time a week for sterile (peripherally inserted central catheter) PICC line dressing changes and lab draws. a) The agency failed to coordinate with Patient #6's physician following a hospitalization to ensure Patient #6 received his PICC line dressing change and lab work. Clinical record review revealed Patient #6 was hospitalized on 5/31/21 for fever and possible sepsis. The agency received resumption of care orders from the hospital on 6/10/21. Review of a communication note dated 6/10/21 revealed the agency Intake Coordinator (Employee #8) called the hospital case manager and the original referring agency case manager to communicate that the agency was unable to resume care because the previous nurse was no longer with the agency and the agency did not have an alternate nurse in the patient's geographic area to provide services. There was no record of any follow-up to ensure Patient #6 had services set up following the hospitalization. Furthermore, there was no evidence the agency had communicated with Patient #6's physician regarding their inability to continue services. Clinical record review revealed no evidence of coordinating care with Patient #6's primary care physician upon admission to the hospital, during hospitalization or discharge from the hospital. Review of a communication note dated 6/14/21 revealed, Patient #6's mother inquired "where the nurse was" to provide care. The agency notified Patient #6's mother that the hospital had sent a referral to another homecare agency to provide services. Record review revealed no evidence the agency had coordinated with Patient #6's physician regarding the inability to continue providing care. Furthermore, the agency had not contacted the physician to get discharge orders. During an interview on 6/21/21 at approximately 12:56 p.m. Patient #6's mother stated the patient was discharged from the hospital on 6/10/21. She was expecting Nurse #3 on 6/14/21 to draw labs and change the PICC line dressing. In a phone call with the Director of Clinical Services (DCS) on 6/14/21 the mother was informed that Nurse #3 was no longer with the agency and the hospital had referred the case to another agency. Patient #6's mother declined the homecare agency assigned by the hospital. She reported Patient #6's labs and PICC line dressing change were now scheduled in a clinic. During an interview on 6/18/21 at approximately 3:15 p.m. the DCS confirmed Nurse #3 was terminated from employment on 6/14/21. She stated the agency did not have another nurse in the geographic location of the patient to resume care. During an interview on 6/21/21 at approximately 1:56 p.m., the DCS stated the agency thought it would be best for Patient #6 care to be provided by a pediatric nurse, which the agency did not have available. After the patient was discharged from the hospital the agency did not call or visit Patient #6 within 48 hours of discharge because they "assumed" care was being provided by another agency. 2. The clinical record for Patient #7 was reviewed on 6/18/21. The Plan of Care for the certification period dated 4/15/21 to 6/13/21 revealed a start of care date of 4/15/21; diagnoses included paroxysmal nocturnal hemoglobinuria (PNH),autoimmune hemolytic anemia, acute embolism and thrombosis, chronic obstructive pulmonary disease, pulmonary embolism, long term use of anticoagulants and dependence on supplemental oxygen. Plan of Care orders included SN visits every twelve days for eculizumab (Soliris) 900 mg IV infusion. a) The agency failed to coordinate care with Patient #7's physician regarding a missed Soliris infusion which left the patient in danger of red blood cell destruction. During an interview on 6/24/21 at approximately 1:15 p.m., Patient #7 reported he was diagnosed with PNH which requires Soliris 900 mg intravenously every twelve days for anticoagulation. He reported that in 2005-2007 he participated in an Soliris clinical trial at Stanford University. During the trial he experienced episodes of hemolysis (the destruction of red blood cells) on day 13 or 14 after the Soliris infusion. Stanford University obtained Federal Drug Administration (FDA) approval for Patient #7 to receive Soliris infusion every twelve days instead of the manufacturer's recommended fourteen day regimen due to the increased risk of blood clots, hospitalization or death. Continued interview revealed, Patient #7 reported on 6/13/21 Nurse #7 came to his home to complete a recertification assessment. Patient #7 reported Nurse #7 was at his home for approximately ten minutes and only took his blood pressure, pulse oximetry and asked if he was on any medications. Patient #7 reported that the nurse did not inquire about names, doses or times of medications. The nurse told Patient #7, a nurse would call before the scheduled 6/14/21 infusion, however, a nurse did not call or come to his home for care on 6/14/21. Continued interview revealed, Patient #7 reported the agency called him on 6/14/21 at 2:49 p.m., to schedule the infusion for 6/15/21 at 10:00 a.m. He stated no nurse came to his home as scheduled for the infusion on 6/15/21. Patient #7 called the agency at 4:00 p.m. and was told the nurse had an emergency. There was no infusion on 6/15/21 and the visit was not rescheduled. Further interview revealed, Patient #7 reported he had the Soliris medication and infusion supplies in his home. On 6/17/21 a family member assisted Patient #7 with the infusion, three days after the scheduled dose was to be administered by the agency nurse. The clinical record for Patient #7 revealed an original start of care date of 2/14/21. Review of SN visit notes revealed completed nursing visits with the provision of the Soliris infusion on 2/14, 2/26, 3/10, 3/22, 4/3, 4/15, 4/27, 5/9, 5/21 and 6/2/21. A SN visit was completed on 6/13/21 for recertification; however, no Soliris infusion was provided at the 6/13/21 nursing visit. The next nursing visit was scheduled for 6/14/21. Review of a communication note dated 6/14/21 signed by the Director of Clinical Services (DCS) revealed a missed nursing visit on 6/14/21 and a new visit scheduled for 6/15/21 at 10:00 a.m. There was no evidence the agency had coordinated care with Patient #7's physician. Review of a communication note dated 6/15/21 revealed Patient #7 called the agency at 4:30 p.m. reporting the nurse had not been to the home to administer the infusion. The note stated the DCS drove to Patient #7's home to provide the service but he was not there. Record review failed to reveal further attempts to schedule the infusion. There was no evidence the agency had coordinated care with Patient #7's physician. During an interview with the DCS on 6/18/21 at approximately 3:15 p.m., the DCS stated the regular nurse (Nurse #3) was suspended on 6/10/21 and terminated employment with the agency on 6/14/21. Nurse #3's termination of employment resulted in changes in staffing Patient #7's infusion. Continued interview revealed, the DCS stated she went to Patient #7's home the evening of 6/15/21 but the patient did not answer the door and she was unable to communicate with him regarding his care. As of 6/18/21, the DCS was not sure if Patient #7 had received the Soliris infusion. Review of email communication to Patient #7 from the Agency Administrator on 6/21/21 at 3:56 p.m., seven days after the scheduled infusion, stated that the nurse scheduled on 6/14/21 was "very distraught" due to a "critical family emergency" and was unable to provide care as scheduled. The email further read " we contacted your doctor and per your MD you did not receive your IV infusion in their office. You definitely need your infusion as soon as possible." Review of agency communication notes failed to reveal any communication with Patient #7's physician to discuss how to proceed with patient care regarding missed time sensitive medication administration.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to coordinate care delivery with the patient and involve the patient, representative and caregiver in the coordination of care activities in order to meet the needs of the patient for 2 of 6 patients reviewed who received skilled nursing (SN) for intravenous (IV) care (Patients #6 and #7). Findings include: 1. The clinical record for pediatric Patient #6 was reviewed on 6/18/21. The Plan of Care for the certification dated 4/21/21-6/19/21 revealed a start of care date of 12/22/20; diagnosis included preterm newborn-29 weeks gestational, gastrostomy, intestinal malabsorption, moderate protein malnutrition and chronic respiratory disease. Plan of Care orders included SN visits one time a week for sterile (peripherally inserted central catheter) PICC line dressing changes and lab draws. a) The agency failed to coordinate with the patient's caregiver and external providers involved in the provision of home health services for Patient #6 to ensure collaboration of care and services to meet the patient's needs following a hospitalization. Clinical record review revealed Patient #6 was hospitalized on 5/31/21 for fever and possible sepsis. The agency received resumption of care orders from the hospital on 6/10/21. Review of a communication note dated 6/10/21 revealed the agency Intake Coordinator (Employee #8) called the hospital case manager and the original referring agency case manager to communicate that the agency was unable to resume care because the previous nurse was no longer with the agency and the agency did not have an alternate nurse in the patient's geographic area to provide services. There was no record of any follow-up to ensure Patient #6 had services set up following the hospitalization. Furthermore, there was no evidence the agency had communicated with Patient #6's caregiver regarding their inability to continue services. Review of a communication note dated 6/22/21 revealed the Director of Nursing (DON) documented a phone call with Patient #6's caregiver as a late entry that occurred on 6/10/21. The DON documented the phone call was to find out about care and services received during the hospitalization. There was no evidence the DON had informed Patient #6's caregiver about the agency's inability to continue providing services for Patient #6. Record review failed to reveal the agency communicated to Patient #6's mother that the agency would not resume home care services following discharge from the hospital. Record record revealed communication note dated 6/14/21 Patient #6's mother inquired "where the nurse was" to provide care. The agency notified Patient #6's mother that the hospital had sent a referral to another homecare agency to provide services. During an interview on 6/21/21 at approximately 12:56 p.m. Patient #6's mother stated the patient was discharged from the hospital on 6/10/21. She was expecting Nurse #3 on 6/14/21 to draw labs and change the PICC line dressing. In a phone call with the Director of Clinical Services (DCS) on 6/14/21 the mother was informed that Nurse #3 was no longer with the agency and the hospital had referred the case to another agency. Patient #6's mother declined the homecare agency assigned by the hospital. She reported Patient #6's labs and PICC line dressing change were now scheduled in a clinic. During an interview on 6/18/21 at approximately 3:15 p.m. the DCS confirmed Nurse #3 was terminated from employment on 6/14/21. She stated the agency did not have another nurse in the geographic location of the patient to resume care. During an interview on 6/21/21 at approximately 1:56 p.m, the DCS stated the agency thought it would be best for Patient #6 care to be provided by a pediatric nurse, which the agency did not have available. After the patient was discharged from the hospital the agency did not call or visit Patient #6 within 48 hours of discharge because they "assumed" care was being provided by another agency. 2. The clinical record for Patient #7 was reviewed on 6/18/21. The Plan of Care for the certification period dated 4/15/21 to 6/13/21 revealed a start of care date of 4/15/21; diagnoses included paroxysmal nocturnal hemoglobinuria (PNH),autoimmune hemolytic anemia, acute embolism and thrombosis, chronic obstructive pulmonary disease, pulmonary embolism, long term use of anticoagulants and dependence on supplemental oxygen. Plan of Care orders included SN visits every twelve days for eculizumab 900 mg intravenous infusion. a) The agency failed to coordinate with the patient and external providers involved in the provision of home health services for Patient #7 to ensure collaboration of care and services to meet the patient's needs. During an interview on 6/24/21 at approximately 1:15 p.m., Patient #7 reported he has a diagnosis of chronic PNH which requires eculizumab 900 mg intravenously every twelve days for anticoagulation. He reported that in 2005-2007 he participated in an eculizumab clinical trial at Stanford University. During the trial he experienced episodes of hemolysis at day 13 or 14 after the eculizumab infusion. Stanford University obtained Federal Drug Administration (FDA) approval for Patient #7 to receive eculizumab infusion every twelve days instead of the manufacturer's recommended fourteen day regimen due to the increased risk of blood clots, hospitalization or death. Patient #7 reported on 6/13/21 Nurse #7 came to his home for recertification of care. He reported Nurse #7 was at his home for approximately ten minutes. Patient #7 reported the nurse took a blood pressure, pulse oximetry and asked if he was on any medications. Patient #7 reported that the nurse did not inquire about names, doses or times of medications. The nurse told the patient a nurse would call before the 6/14/21 eculizumab infusion. However, a nurse did not call or come to his home for care on 6/14/21. Patient #7 reported the agency called him on 6/14/21 at 2:49 p.m., to schedule the infusion for 6/15/21 at 10:00 a.m. He stated no nurse came to his home as scheduled for the infusion on 6/15/21. He called the agency at 4:00 p.m. and was told the nurse had an emergency. There was no infusion on 6/15/21 and the visit was not rescheduled. Patient #7 reports he had the eculizumab medication and infusion supplies in his home. On 6/17/21 a family member assisted Patient #7 with the eculizumab infusion, three days after the scheduled dose was to be administered. The clinical record for Patient #7 revealed original start of care 2/14/21. Further review of the SN visit notes revealed completed nursing visits on 2/14/21, 2/26/21, 3/10/21, 3/22/21, 4/3/21, 4/15/21, 4/27/21, 5/9/21, 5/21/21 and 6/2/21. A SN visit was completed on 6/13/21 for recertification. No infusion was given at the 6/13/21 nursing visit. The next nursing visit was scheduled 6/14/21. Review of a communication note dated 6/14/21 signed by the Director of Clinical Services (DCS) revealed a missed nursing visit on 6/14/21 and a new visit scheduled for 6/15/21 at 10:00 a.m. Review of an agency communication note dated 6/15/21 revealed Patient #7 called the agency at 4:30 p.m. reporting the nurse had not been to the home to administer the infusion. The note stated the DCS drove to Patient #7's home to provide the service but he was not there. Record review failed to reveal further attempts to schedule the infusion. During an interview with the DCS on 6/18/21 at approximately 3:15 p.m., the DCS stated the regular nurse (Nurse #3) was suspended on 6/10/21 and terminated employment with the agency on 6/14/21. Nurse #3 termination of employment resulted in changes in staffing Patient #7's care. The DCS stated she went to Patient #7's home the evening of 6/15/21 but the patient did not answer the door and she was unable to communicate with him regarding his care. As of 6/18/21, the DSC was not sure if Patient #7 had received the eculizumab infusion. Email communication to Patient #7 from the Agency Administrator on 6/21/21 at 3:56 p.m., seven days after the scheduled infusion, stated that the nurse scheduled on 6/14/21 was "very distraught" due to a "critical family emergency" and was unable to provide care as scheduled. This email also stated " we contacted your doctor and per your MD you did not receive your IV infusion in their office. You definitely need your infusion as soon as possible. Review of agency communication notes failed to reveal any communication with Patient #7's physician to discuss how to proceed with patient care regarding missed time sensitive medication administration.