Every finding on record at American Institute of Medical Solutions, LLC

Extended Substantial Allegation Survey Substantial Allegation 62162 An entrance conference was conducted with administrative staff on 04/04/22 at 9:45 AM, and an exit conference was completed with the administrative staff on 04/05/22 at 4:30 PM The following deficiencies are based on the Substantial Allegation Survey completed on 04/05/22. Bluegreen Home Health Care 368479 is not in compliance with regulations at CFR Part 484, Subpart B, C for Home Health Agencies in regard to allegations contained in substantial allegation 62162.. On 04/04/22 at 3:37 PM the Administrator and Office Manager were informed a determination of Immediate Jeopardy was made under Infection Control. On 04/04/22 it was determined only 4.9% of the agency staff were vaccinated against Covid-19 creating a likelihood of serious harm. In addition, the agency did not have a contingency plan in place for unvaccinated staff and did not have a process in place for tracking employee vaccination status, medical/religious exemptions and/or and temporary delay according to CDC guidelines. An action plan was received on 04/05/22 and approved on 04/05/22 at 2:38 PM. On 04/05/22 at 3:44 PM, the Administrator and Office Manager was informed the Immediate Jeopardy under Infection Control was removed. Bluegreen Home Health Care is precluded from offering its own aide training and/or competency evaluation program for a period of two years from the exit date of this survey.

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 home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. 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 issuance of the memo. The agency’s percentage of vaccinated staff for COVID-19 was 4.9%. Additionally, the agency did not have a contingency plan in their policy for unvaccinated staff to prevent the spread of COVID-19 and the agency did not develop a process for tracking COVID-19 vaccination status and/or exemption status. This affected 176 staff members (144 Home Health Aides, 6 Registered Nurses, 13 Licensed Practical Nurses, 1 Office Staff, and 4 Drivers). The agency active census was 129 patients. Findings include: Review of QSO memo 22-09-ALL Attachment D, 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 CDC. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. The policies and procedures must include a process for tracking and securely documenting the COVID-19 vaccination status of all staff, 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, 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, and contingency plans for staff who are not fully vaccinated for COVID-19. Review of the agency policy titled, “Covid-19 Vaccination Program,” revealed the agency has established a COVID-19 vaccination program for patient care staff, contract staff, and licensed independent practitioners. All employees are required to receive vaccinations as determined by CMS, unless a reasonable accommodation is approved. Employees not in compliance with this policy will be placed on unpaid leave until their employment status is determined by the human resource department. An interview was conducted with the Staff C on 04/04/22 at 10:05 AM who reported the agency did not receive the QSO-09-22 -ALL memorandum issued on 01/14/22 with regard to the COVID-19 vaccine requirements. The agency had employees that were vaccinated; however, not everyone had turned in their vaccine card. Staff C confirmed the agency did not have a contingency plan for unvaccinated employees and/or a system in place for tracking the COVID -19 vaccination status or exemptions for employees. Review of the staff vaccination records with the Staff C on 04/04/22 revealed there were no COVID-19 vaccinations or exemptions on file for the following employees who provided direct patient care: 144 Home Health Aides, 6 Registered Nurses, 13 Licensed Practical Nurses, 1 Office Staff, and 4 Drivers. The agency had a total of 185 employees with 9 vaccinated employees for a vaccination rate of 4.9%. Interview with Staff A on 04/04/22 at 3:37 PM confirmed the staff identified above had either not received or submitted their COVID-19 vaccination status or did not have an exemption on file. The agency was unaware of the COVID-19 vaccine memorandum issued 01/14/22. The agency would work to get into compliance for this requirement. The agency plan was that 100% of employees would be vaccinated by 04/15/22 or have exemptions on file. Further, if staff had not started the vaccination series or received an exemption, they would be terminated or removed from the schedule. Those with exemptions who would not receive the vaccination would be required to wear N-95 masks when in patients' homes. This deficiency substantiates Substantial Allegation 62162.