Every finding on record at Trinity Home Health Services

This Agency was determined to be in Immediate Jeopardy which was identified on 8/8/22 at 2:28 p.m. A plan to remove the Immediacy was submitted, reviewed by the State Authority and accepted. The Immediate Jeopardy was removed on 8/8/22 at 5:42 p.m. The Condition and Standard level deficiencies were identified during a Medicare authorized Complaint Investigation (MI00071398) conducted by the Michigan Department of Licensing and Regulatory Affairs on 8/4/22 through 8/8/22 at: St. Joseph Mercy Home Care & Hospice (Trinity at Home Health) 34505 W. Twelve Mile Rd., Suite 100 Farmington Hills, MI 48331 This Agency had no additional branch locations. Clinical records reviewed for this survey included: 2 active records without home visits, 1 active record without home visit (Patient on hold), and 1 discharged record, for a total of 4 records reviewed. At the conclusion of this survey, the Agency was determined to be non-compliant with the Conditions of Participation at sub part 42 CFR Home Health Agencies. The following Conditions were Identified: 42 CFR §484.70 Infection Prevention and Control. The Agency's Vice President of Virtual Operations (Administrator) and Regional Director of Operations were notified of the Immediate Jeopardy on 8/8/22 at 3:12 p.m. The Immediate Jeopardy was removed on 8/8/22 at 5:42 p.m. upon receipt of an acceptable Plan to Remove the Immediacy. As a result of the Condition level noncompliance, the Agency is prohibited for 2 years from offering a Home Health Aide training and competency evaluation or a competency evaluation program as specified in 42 CFR §484.80(f)(3).

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 record review and interview, the Agency failed to ensure its disciplines implemented effective Infection Control measures including wearing appropriate personal protective equipment during the provision of care, and refraining from providing patient care when ill, for 2 (MR's #1, 4) of 2 patients who contracted Covid-19 after receiving care from the Occupational Therapist, who also, subsequently tested positive for Covid-19, from a total of 4 sampled records reviewed, resulting in MR #1 contracting Covid-19 with resultant hospitalization, MR #4 contracting Covid-19, and the potential for the ongoing development and spread of infection to the 7 remaining patients who were seen by the Occupational Therapist during this time frame, as well as all staff and the 1050 patients currently serviced by this Agency. This resulted in Immediate Jeopardy (IJ) to the health and safety of MR #1 as a result of the entity's failure to utilize the required personal protective equipment when providing care and staff providing care when not feeling well (G682); failed to provide documented evidence to ensure that all disciplines who were granted clinical privileges were pre-screened for the Covid-19 virus prior to the provision of care and services for 2 (MR #1, 4) of 2 patients, from a total of 4 sampled records reviewed, resulting in both patients contracting Covid-19 with resultant hospitalization for MR #1 (G684). The cumulative effect of these systemic problems resulted in the Agency's inability to ensure the provision of Quality Health Care in a safe environment for the Condition of Participation 42 CFR §484.70 Infection Prevention and Control.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on record review and interview, the Agency failed to ensure its disciplines implemented effective Infection Control measures including wearing appropriate personal protective equipment during the provision of care, and refraining from providing patient care when ill, for 2 (MR's #1, 4) of 2 patients who contracted Covid-19 after receiving care from the Occupational Therapist, who also, subsequently tested positive for Covid-19, from a total of 4 sampled records reviewed, resulting in MR #1 contracting Covid-19 with resultant hospitalization, MR #4 contracting Covid-19, and the potential for the ongoing development and spread of infection to the 7 remaining patients who were seen by the Occupational Therapist during this time frame, as well as all staff and the 1050 patients currently serviced by this Agency. Findings include: Policy: "COVID-19 Prevention" July 8. 2021 stated, "Any Employee who has received an approved exemption for either medical or religious reasons, should be instructed to follow this guidance to prevent transmission of the virus to patients, coworkers, or others in their work environment: If possible, based on required job duties, consider scheduling the exempted Employee on an alternate shift when there is less contact with others..., Screening for newly identified infection, symptoms or close contact exposure to someone with COVID-19 is completed for all Employees, including those with approved exemption, prior to each shift worked in the clinical setting..., "If the exempted Employee develops any symptoms consistent with COVID-19, they should report to their supervisor and arrange to immediately leave the premises and be tested." Policy: "Infection Prevention and Control" - 12/9/2021 stated, "COVID-19 Vaccinations: In appropriate circumstances, Trinity Health will permit an exemption for either medical contraindications or as a religious accommodation, and those personnel exempted must take the precautions of wearing an N95 mask during the period designated for prevention of the spread of COVID-19 as defined by their affiliated Ministry." Policy: "Job Aid: N95" Pages 26-27 of PPE handbook that reviews wear time, donning and doffing pages" stated, CDC recommends limiting the number of reuses to no more than five uses (five donnings) for each N95 respirator used by an individual colleague; A colleague participating in a limited reuse program must discard their disposable respirator, e.g. N95, and obtain a new one when any of the following criteria are met: Once the respirator has been doffed a total of five (5) times." A complaint on file alleged that the Occupational Therapist (OT #1) was not wearing the required PPE (personal protective equipment) during a visit to the patient's (MR #1) home during the week of 6/26/22. The complaint stated that OT #1 had on a red cloth mask instead of the required N95 mask to which she (OT #1) said a friend makes for her. During the visit, OT #1 was alleged to have stated to the patient's wife that she (OT #1) had many cloth masks and would get her (patient's wife) one. It was further reported that during the home visit, the patient's wife was sitting next to OT #1 and was able to observe her cloth mask closely. OT #1 saw the patient on 6/27/22 reportedly wearing a red cloth mask. The OT was scheduled to make another visit to see the patient on 6/29/22 but called in sick, 2 days after being in the patient's home. It was alleged that OT #1 had reported not feeling well that same day (6/27/22), and subsequently tested positive for Covid-19. The complaint further reported that the patient began experiencing symptoms (weakness, lethargic) on Wednesday evening (6/29/22) and Thursday morning (6/30/22). On Friday 7/1/22, the patient was transferred to the hospital Emergency Room where he tested positive for Covid-19 and was subsequently hospitalized for 10 days. Further review of the complaint on file revealed that the patient's wife became symptomatic and also tested positive for Covid-19 within days of OT #1's visit to their home. On 8/4/22 at 10:15 a.m., during the onsite investigation, an interview was conducted with the Administrative Assistant (AA #1) who reported that all staff receive standard supplies upon hire. AA #1 confirmed that this does not include N95 masks. AA #1 went on to state that the disciplines can order their own necessary Personal Protective Equipment (PPE) equipment via the Agency's online ordering system (Cardinal). When asked if there were any orders for N95 masks placed by OT #1, AA #1 and an unidentified staff person stated, "No." On 8/4/22, a request was made to review the Agency's Complaint Log. A document titled, "Concern Report" dated 7/21/22 documented, "All staff knew that the patient and family were very nervous about getting Covid. This was discussed by the wife with all the clinicians. The patient and the wife wore a cloth mask while the staff were in the home. Clinical Manager (CM #2) interviewed all staff involved in the case regarding the complaint made. Below are the results of those interviews. OT #1 - last visit make [sic] on Monday 6/27..., On Monday 6/27 OT #1 had a headache..., While working on Monday (6/27) and Tuesday (6/28) OT #1 wore a surgical mask with a cloth mask over the surgical mask. This matches the report that the cloth mask was worn... On Wednesday 6/29/22 OT #1's symptoms worsened so she called in sick to work and went to see her health care provider where she tested positive for COVID..., Opportunities: When OT #1 had a headache and was testing for COVID each day she could have chosen to wear an N-95 mask as a precautionary measure vs (versus) the surgical mask with a cloth mask over the surgical mask. OT #1 should not wear any cloth masks. If she wanted to double mask it should be two surgical masks instead. Contact tracing was not completed timely prior to family calling to inquire... Plan: Educate staff to wear an N-95 mask if they have new onset of any symptoms as a precautionary measure..." This logged complaint was signed by the Regional Director of Home Care Operations (RD #1) on 7/18/22. The Agency acknowledged that OT #1 was not wearing the proper PPE during the provision of care and services. On 8/4/22 at 11:10 a.m., an interview was conducted with the Regional Director (RD #1) regarding the complaint. RD #1 acknowledged being aware of the complaint and reported that the Agency had investigated the matter. When asked if OT #1 had since returned to work, RD #1 stated, "Yes. I think she returned on 7/15/22." When queried as to the employee screening process, RD #1 stated, "The disciplines self-screen." When asked if there was a process in place to ensure disciplines are wearing the proper PPE, RD #1 reported, "We (Clinical Managers) do monthly joint visits to observe the staff." When queried about the last joint visit conducted with OT #1, RD #1 stated, "Let me take a look right quick. (Searching through her laptop). No. I don't see that one was done. The Clinical Manager (CM #2) did 3 joint visits, but none were conducted with OT #1." During a review of OT #1's vaccination status in conjunction with the Agency's Vaccine protocol/policy, it was noted that OT #1 had not been vaccinated and held a medical exemption. Per this Agency's policy, all personnel who have not been vaccinated due to waivers must wear an N95 mask during the provision of care. MR #1: On 8/4/22 at 12:45 p.m., during a review of the clinical record, it was noted that the patient was admitted to home care on 6/19/22 with diagnoses that included Parkinson's Disease, Pressure Ulcers and Diabetes Mellitus. At the time of admission, the patient did not present with a diagnosis of Covid-19. The referral for home care dated 6/16/22 ordered Skilled Nursing (SN), Home Health Aide (HHa), Physical therapy (PT), Occupational Therapy (OT) and Speech Therapy (ST) services to be provided. The patient's Hospital Emergency Room paperwork dated 7/1/22 documented, "patient's wife states that patient had sudden onset of generalized weakness and change in appetite..., patient was febrile (fever) at home today..., Patient was reported to have had loose stools and a temperature of 100.9 prior to arrival to the hospital..., Assessment & Plan: COVID-19 positive. Patient's triply vaccinated. Meets criteria for severe disease. Pulse ox (oxygen) <94% on room air..., Patient placed in isolation] droplet/contact] [sic]." By the end of the day on 8/4/22, RD #1 reported to this writer that she meant to update the complaint investigation documentation dated 7/21/22, to reflect that OT #1 was wearing an N95 mask and not a surgical mask as initially documented. RD #1 stated, "I meant to change it. I don't know what happened. I didn't update my notes. Can I change it?" There was no documented evidence that OT #1 was wearing the proper and required PPE (N95 mask) during the provision of care. On 8/8/22 upon arrival to the Agency at 9:10 a.m., a list of patient's serviced by OT #1 during the week of 6/26/22 was requested. RD #1 replied, "I found some additional information if you'd like to see it." RD #1 submitted a typed "Word" document that was different from the findings within the Agency's initial complaint investigation and stated, "I hope you will consider this." Upon review, the document stated, OT #1 "...wears a N95 and a cloth mask on top." RD #1 then stated, "I know I didn't write this in the initial investigation." When queried about the author of the original investigation, RD #1 acknowledged that she in fact documented the findings/outcome of the Agency's investigation as it was presented to this writer, which confirmed that OT #1 was not wearing the required N95 mask during the home visit with MR #1 on 6/27/22. RD #1 also provided a document titled "Field Supervision Visit Report" dated 7/13/22. When queried as to the nature of the document, RD #1 reported that staff screen each other. RD #1 later reported that the Managers conduct onsite supervisory visits twice a month and stated, "I found that only one supervisory visit was done in June. There were none done in July." RD #1 presented a document titled "Joint Commission Compliance form - Home Care", dated 6/1/22 which had check marks next to subjects such as: Infection control-proper equipment... RD #1 then submitted a list of patients who had received services from OT #1 during the week of 6/26/22 which revealed OT #1 conducted home visits for a total of nine (9) patients during the week in question. During the review, it was discovered that OT #1 also made a home visit to see MR #4 that same day (6/27/22) and continued to see patients on 6/28/22 after complaining of being ill. Although the patient (MR #4) had medical dialysis appointments during that same week, RD #1 reported that he (MR #4) had subsequently tested positive for Covid-19 on the same date, 7/1/22 after receiving care from OT #1 on 6/27/22, who tested positive for Covid-19 herself. Additionally, there was no documented evidence that the remaining 7 patients who received services from OT #1 were notified of a possible Covid-19 exposure. On 8/8/22 at 10:26 a.m., an interview was conducted with the Clinical Manager (CM #2) during the interview CM #2 stated, "RD #1 notified me and asked me to interview all the staff that were assigned to MR #1. I documented who I spoke to." CM #2 confirmed an interview was conducted with OT #1 who acknowledged wearing a surgical mask underneath a cloth mask. On 8/8/22 at 10:11 a.m., during a telephone interview, the patient's wife (complainant) reported, "The Manager (RD #1) called me to fill me in about the complaint. She said they talked to all the Therapists about the issue and stated that OT #1 was wearing a surgical mask underneath her cloth mask." On 8/8/22 at 12:21 p.m., an interview was conducted with the Agency's Clinical Educator (CE #1). During the interview CE #1 reviewed a document used to indicate when the disciplines were fit tested for the N95 mask and how many mask were provided. It was revealed that OT #1 received 3 N95 masks on 4/22/21. A date of 11/26/21 was listed but did not include the amount of masks provided. CE #1 stated, "She (OT #1) would have received 3 masks." When queried about the projected use of the N95 masks, CE #1 reported, "The disciplines are only to use the masks up to 5 times each or wear the masks for 5 hours. At that time, the discipline is to place the mask in a brown paper bag and dispose of it." This information was reflected in the Agency's policy. There was no documented evidence that OT #1 was in possession of the required PPE in light of the quantity of masks provided on the dates listed in addition to the disposal requirement. The Agency failed to ensure the disciplines (OT #1) implemented Infection Control Measures, (specifically the use of the required N95 mask) during the provision of care which resulting in increased exposure to and contracting of the Covid-19 virus. These findings were reviewed with and acknowledged by the Administrator (VP #1) and the Regional Director (RD #1) during an interview on 8/8/22 at 3:12 p.m.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on interview, the Agency failed to provide documented evidence to ensure that all disciplines who were granted clinical privileges were screened for the Covid-19 virus prior to the provision of care and services for 2 (MR #1, 4) of 2 patients, from a total of 4 sampled records reviewed, resulting in both patients contracting Covid-19 with resultant hospitalization for MR #1. Findings include: Policy: "COVID-19 Prevention" July 8. 2021 stated, "Screening for newly identified infection, symptoms or close contact exposure to someone with COVID-19 is completed for all Employees, including those with approved exemption, prior to each shift worked in the clinical setting." MR #1: The patient's start of care (SOC) was 6/19/22 with diagnoses that included Parkinson's Disease, Pressure Ulcers and Diabetes Mellitus. During the clinical record review on 8/4/22 at 12:45 p.m., it was noted that the referral for home care ordered Skilled Nursing (SN), Physical Therapy (PT), Home Health Aide (HHa), Speech Therapy (ST) and Occupational Therapy (OT) services to be provided. Further review of the clinical record revealed that the patient was transferred to the hospital on 7/1/22 and was diagnosed with Covid-19. A review of a complaint on file documented that the Occupational Therapist (OT #1) complained of not feeling well on 6/27/22 which is the date OT #1 visited the patient's home. It was later revealed that OT #1 was also diagnosed with Covid-19. On 8/4/22 at 3:32 p.m., an interview was conducted with the Regional Director (RD #1). When queried about the Covid-19 screening process for staff who provide patient care, RD #1 reported, "The staff screen themselves." When asked if there was any documented evidence of staff self screenings, RD #1 stated, "No." The Agency failed to provide documented evidence that all disciplines who were granted clinical privileges were screened for Covid-19 prior to the provision of care. MR #4: The patient's SOC was 6/17/22 with diagnoses that included Rotator Cuff Tear, Chronic Atrial Fibrillation and Congestive Heart Failure. During the record review on 8/8/22, it was noted that the patient was ordered to receive SN, PT and OT services. It was further noted that OT #1 also provided therapy services for this patient on 6/27/22. During an interview on 8/8/22, the Regional Director (RD #1) reported that this patient was diagnosed with Covid-19 on 7/1/22 and had received therapy services from OT #1, who was also diagnosed with Covid-19. The Agency failed to provide documented evidence that all disciplines who were granted clinical privileges were pre-screened for Covid-19 prior to the provision of care.