Every finding on record at Aspen Home Healthcare, LLC

Extended Substantial Allegation Survey Substantial Allegation 62459 and 62393 An entrance conference was conducted with administrative staff on 03/22/22 at 10:20 AM, and an exit conference was completed with the administrative staff on 03/24/22 at 5:39 PM On 03/24/22 at 12:33 PM the Administrator and Director of Operations was informed a determination of Immediate Jeopardy was made under Infection Control. On 03/24/22 it was determined 50.7 % of the agency staff were unvaccinated against COVID-19 creating a likelihood of serious harm. An action plan was received on 03/24/22 and approved on 03/24/22 at 4:45 PM. On 03/24/22 at 5:39PM, the Administrator, Director of Operations, Director of Nursing was informed the Immediate Jeopardy under Infection Control was removed. The following deficiencies are based on the Federal Vaccine Mandate QSO 22-09- All review, completed on 03/24/22 at Aspen Home Healthcare, LLC 368395. No deficiencies were issued in regard to allegations contained in substantial allegation 62459 and 62393 investigated concurrently.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on review of QSO memo 22-09-ALL Attachment G, review of facility COVID-19 vaccination records, staff interview, and review of the facility policy, the facility failed to ensure 100% of the staff were vaccinated within 60 days or have been granted a qualifying exemption, or are identified as having a temporary delay as recommended by the Centers for Disease Control and Prevention (CDC). The cumulative effect of these systemic practices resulted in the agency's inability to ensure that the patients' infection control needs would be met. (G687)

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on review of QSO memo 22-09-ALL Attachment G, review of facility COVID-19 vaccination records, staff interview, and review of the facility policy, the facility failed to ensure 100% of staff were either vaccinated or have been granted a qualifying exemption, or are identified as having a temporary delay as recommended by the Centers for Disease Control and Prevention (CDC) within 60 days from the effective date of the healthcare worker vaccine mandate. The agency’s percentage of unvaccinated staff for COVID-19 was 50.7%. This affected 35 of 69 staff members (Home Health Aide #1, #3, #4, #6, #9, #13, #14, #16, #17, #22, #23, #24, #28, #29, #33, #34, #36, #37, #41, #43, #45, #49, #50, #57, #59, #60, #61, #62, #63, #65, #66, #67, and #68, and Nurse #20 and #34). Thirty five patients were receiving care from the 35 unvaccinated staff. The agency census was 70. Findings include: Review of QSO memo 22-09-ALL Attachment G, dated 01/14/22, revealed within 60 days of issuance of this memorandum, 100% of staff have received the necessary doses to complete the vaccine series (i.e., one dose of a single-dose vaccine or all doses of a multiple vaccine series) or have been granted a qualifying exemption, or are identified as having a temporary delay as recommended by the Centers for Disease Control and Prevention (CDC),. Review of the agency policy titled, “Covid-19 Vaccination Mandate Policy,” approved 01/10/22, revealed staff were to have received one dose of the COVID-19 vaccine prior to 02/14/22 and a second dose of the COVID-19 vaccine no later than 03/15/22. The policy also revealed the agency must demonstrate 100% compliance with the vaccination mandate. Review of staff vaccination records with Staff A, Staff Band Staff C on 03/24/22 at 9:20 AM revealed there were no COVID-19 vaccinations or exemptions on file for the following employees who provided direct patient care: Home Health Aide #1, #3, #4, #6, #9, #13, #14, #16, #17, #22, #23, #24, #28, #29, #33, #34, #36, #37, #41, #43, #45, #49, #50, #57, #59, #60, #61, #62, #63, #65, #66, #67, and #68, and Nurse #20 and #34. Interview with the administrative staff on 03/24/22 at 11:07 AM confirmed the staff identified above had not received the COVID-19 vaccination or had an exemption on file. Staff B stated the agency plan, according to the policy, was that 100% of employees would be vaccinated by 03/15/22 or have exemptions on file. Staff C further stated if staff had not started the vaccination series or received an exemption, they would be terminated or removed from the schedule. Staff B also stated those with exemptions who would not receive the vaccination would be tested weekly and wear N-95 masks when in patients’ homes. The agency identified thirty-five patients were receiving care from the 35 unvaccinated staff members.