EMERGENCY PREPAREDNESS SURVEY At the time of the emergency preparedness survey completed on 03/14/22, Peace and Serenity Home Health Care is in compliance with the provisions of 42 CFR Part 484.102, Conditions of Participation for Home Health Agencies.
Every finding on record at Sanctuary Skilled Home Healthcare, LLC
Ashtabula, Ohio · CCN 368497
7 findings across 1 survey, in the inspector's own words.
The inspector’s own words from form CMS-2567, unedited, including CMS’s own spacing. Names and some dates are redacted by CMS.
Survey of March 14, 2022
7 findingsExtended Recertification Survey An entrance conference was conducted on 03/07/22 at 10:00 AM with the Administrator, an exit conference was conducted on 03/14/22 at 2:00 PM with the Administrator. The following deficiencies are based on the extended recertification survey completed 03/14/22. Peace and Serenity Home Health Care 368497, is not in compliance with the requirements found at 42 CFR Part 484, Subpart B, C for Home Health Agencies. Peace and Serenity Home Health Care is precluded from providing its own home health aide training and competency testing or competency evaluation program for a period of two years from the date of the receipt of the deficiency report (2567) for 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 the Centers for Medicare & Medicaid Services (CMS) memorandum QSO-22-09-ALL Attachment D, record review and staff interview, 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 the Centers for Medicare & Medicaid Services (CMS) memorandum QSO-22-09-ALL Attachment D, record review and staff interview, the agency failed to ensure at least 100% of staff have received at least one dose of COVID-19 vaccine or have a pending request for, 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 30 days from the effective date of the healthcare worker vaccine mandate. The agency's percentage of vaccinated staff for COVID-19 was 83.3%. Additionally, the agency failed to develop a process to track and document vaccine status of all staff and staff with boosters per CDC, failed to develop a process to track and document information provided by staff requesting exemptions and who agency has granted, failed to develop a process to ensure all documentation confirms clinical contraindications, supports staff request for medical exemptions and must be signed and dated by the Physician, failed to develop a process to document and evaluate religious exemptions, and failed to develop a process to track and document staff where vaccine is delayed, as recommended by the Centers for Disease Control and Prevention (CDC) and vaccine status of contracted staff. The census was 35. Findings include: Review of QSO memo 22-09-ALL Attachment D, dated 01/14/22, revealed within 30 days of issuance of this memorandum, 100% of staff have received at least one dose of COVID-19 vaccine or have a pending request for, or have been granted a qualifying exemption, or are identified as having a temporary delay as recommended by the CDC. Review of the form titled, "Sample Employee COVID-19 Vaccination Tracking Form" revealed the facility had a total of 12 employees. There were nine employees vaccinated for COVID-19, one with an approved exemption, and two employees who had not received any doses of the COVID-19 revealing a staff vaccination rate of 83.3%. Review of agency policy titled, "Peace and Serenity Home Health Mandatory Vaccination Policy," with no effective date, revealed all employees covered by this policy are required to be fully vaccinated as a term and condition of employment at Peace and Serenity. Employees not in compliance with this policy will be subject to discipline up to and including termination. Employees who are unvaccinated and report to the workplace at least once every seven days must be tested for COVID-19 at least once every seven days; and must provide documentation of the most recent COVID-19 test result to [the supervisor] no later than the seventh day following the date on which the employee last provided a test result. If an employee does not provide documentation of a COVID-19 test result as required by this policy, they will be removed from the workplace until they provide a test result. Review of the agency policy revealed no process to track and document vaccine status of all staff and staff with boosters per CDC, a process to track and document information provided by staff requesting exemptions and who agency has granted, a process to ensure all documentation confirms clinical contraindications, supports staff request for medical exemptions and must be signed and dated by the Physician, a process to document and evaluate religious exemptions, or a process to track and document staff where vaccine is delayed, as recommended by the Centers for Disease Control and Prevention (CDC) and vaccine status of contracted staff. Review of the agency form titled "Sample Employee COVID-19 Vaccination Tracking Form" revealed Staff K was not vaccinated, however only "Letter received" was documented. Further review of the "Sample Employee COVID-19 Vaccination Tracking Form" revealed Staff A and L were not vaccinated. Staff A had not worked since 11/22/21 and Staff L had not worked since 10/19/21. Per interview on 03/07/22 at 11:59 AM Staff C stated it was an exemption letter (religious). Staff C confirmed there was no process to document or track religious and medical exemptions. Staff C also stated both employees were still capable to work at any time. Staff C stated the agency emailed the two contracted companies they did business with and were waiting for their vaccination status. Staff C confirmed there was no process to document or track the vaccination status of the contracted staff. Per interview on 03/08/22 at 11:06 AM Staff K, who had an exemption from the vaccine, stated he/she "was supposed to" test weekly but had not tested at all. Per interview on 03/08/22 at 11:20 AM Staff C confirmed there was no corrective action taken against Staff K per policy.
Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on record review and staff interview, the agency failed to ensure all services were provided as ordered in the plan of care for three of seven patients reviewed (Patient #2, #3 and #6). The census was 35. Findings include: 1. Review of the medical record for Patient #2 revealed a physician order dated 12/21/21 for Occupational Therapy (OT) to assess/evaluate and treat effective 12/22/21. Further review revealed no documentation OT had made a visit to do the assessment/evaluation. Per interview on 03/10/22 at 12:58 PM Staff C confirmed OT did not do an evaluation per physician order. 2. Review of the medical record for Patient #3 revealed a physician order dated 02/02/22 for Physical Therapy (PT) to provide services two times per week. Review of PT visit sheets revealed a missed visit the week of 02/13/22. There was no documentation the physician was notified services were not provided as ordered. Per interview on 03/10/22 at 2:03 PM Staff C confirmed the PT visit as missed and stated the physician had not been notified. 3. Review of medical record for Patient #6 revealed a physician order dated 12/07/21 for skilled nursing serviced to provide wound care three times per week. Review of skilled nursing visit sheets and the missed visit report revealed missed visits on 12/28/21, 12/31/21, 01/04/22, 01/07/22, 01/11/22, 01/14/22, 01/18/22, 01/21/22, and 01/25/22. There was no documentation the physician had been notified services were not provided as ordered. Per interview on 03/14/22 at 10:00 AM Staff C confirmed this finding.
Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and staff interview, the governing body failed to ensure all policies and procedures had been reviewed and updated annually. The census was 35. Findings include: Review of the agency's policy and procedure manual did not reveal the last time the policies and procedures had been reviewed or updated. Per interview on 03/08/22 at 1:30 PM Staff C was unable to provide documentation the policies and procedures were reviewed or updated annually.
Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This ELEMENT is not met as evidenced by: Based on contract review and staff interview, the agency failed to have a current written agreement with another agency when that entity furnishes services under arrangement to the home health agency's patients. This could potentially affect all patients receiving therapy services at this agency. The census was 35. Findings include: Review of the contract titled, "Supplement Staffing Therapy Services Agreement" between this home health agency and Physical Therapy and Occupational Rehabilitation, Inc. entered into on 11/06/2018 revealed the term of agreement was for one year or further extended pursuant to the provisions of this agreement. Further review revealed a lack of any provisions to extend this agreement. Per interview on 03/07/22 at 2:50 PM Staff C confirmed this therapy agreement being currently used had expired 11/06/2019 without provisions to extend the term of agreement. Staff C also stated the therapy company's name had changed in 2019.
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