Every finding on record at Family Care Home Health & Hospice, LLC

A Recertification Survey was conducted by Healthcare Management Solutions, LLC on behalf of the Nevada Department of Health and Human Services. The survey conducted from 07/13/2022 to 07/14/2022 resulted in a finding of standard level citations respective to the Emergency Preparedness Program Condition of Participation under 42 CFR 484.102.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on document review, policy review, and interview, the home health agency (HHA) failed to conduct annual exercises to test the emergency plan. The failure to conduct a test of the emergency plan had the potential to affect the ability of the HHA to respond in the event of an emergency or disaster situation and could impact all current patients. Findings include: Review of a binder labelled as "Emergency Preparedness" included a sign-in sheet with three names on it dated March 21. The binder included exercise scenarios identified as coming from the "Department of Homeland Security" and included "Cyber Attack," "Major Earthquake," "Major Hurricane," "Pandemic Influenza," and "Toxic Industrial Chemical." The documentation did not include evidence of which exercise the agency completed, other staff who may have participated, or an analysis of the HHA's response. The Director of Nursing (DON) presented information that showed a tabletop exercise had been completed over two years earlier in 2020. During an interview on 07/14/2022 at 11:15 AM, the DON stated there was no documentation the agency had ever participated in a community-based event to test the agencies plan and ability to respond in an emergency. Review of an agency policy titled, "Emergency Operations Plan," dated 2015, revealed, "The plan will be tested and evaluated annually at each site … The planned exercise will focus on the Agency's response to an emergency that would likely affect the Agency's ability to continue to serve patients in the event of an emergency."

A Recertification Survey was conducted by Healthcare Management Solutions, LLC on behalf of The State of Nevada Department of Health and Human Services. The survey conducted from 07/13/2022 to 07/14/2022 resulted in a finding of substantial compliance respective to the applicable Condition of Participation (CoP) under 42 CFR 484 Subparts A through C with the following standard-level deficiencies listed below. The agency census was 155.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review, policy review, and interview, the home health agency (HHA) failed to ensure staff performed the initial comprehensive assessment within 48 hours of the referral or discharge from the hospital for one (Patient (P) 5) of seven patient records reviewed. This deficient practice had the potential to affect any patient admitted to the HHA for home health services. Findings include: Review of the undated policy titled "Reassessments/Update of the Comprehensive Assessment," obtained by the agency from the "Policies and Procedures Manual for Home Health Care 2000 MED-PASS, Inc. [incorporated] (Revised 2014)," indicated ". . . Minimally, the comprehensive assessment must be updated and revised: After inpatient stay (Resumption of Care): within 2 calendar days of the facility discharge date or knowledge of patient's return home. . ." Review of P5's electronic medical record (EMR) indicated under the "Referral" tab, there was a referral dated 03/30/2022 for skilled home health services due to "decline in patient condition due to hospitalization." Review of P5's "Physician Order," located under the "Orders" tab in the EMR and dated 04/04/2022, indicated "Patient is being admitted to home health. SN2wk21w7" [skilled nurse two times a week for 2 weeks then one time a week for seven weeks]. There was no documentation of a physician order to delay the start of care to 120 hours after discharge from the hospital. Review of P5's "Home Health Certification and Plan of Care," located under the "Orders" tab in the EMR, indicated P5's start of care date was 04/04/2022. In an interview on 07/13/2022 at 1:40 PM, Director of Nursing (DON) confirmed there was no physician order obtained to delay the admission for home health services for P5.

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on record review, policy review, observation, and interview, the home health agency (HHA) failed to ensure: 1. Verbal orders were signed in accordance with agency policy for three (Patient (P) 1, P2, P4) of seven patient records reviewed and 2. A tracking system was developed for tracking verbal orders that were sent to physicians for signature in accordance with the agency's policy. These deficient practices had the potential to affect the current 155 patients and any future patient admitted for home health services. Findings include: 1. Review of the undated policy titled "Physician Orders – Verbal Orders," obtained by the agency from the "Policies and Procedures Manual for Home Health Care 2000 MED-PASS, Inc. [incorporated] (Revised 2014)," indicated ". . . 1. Orders for patient care are obtained from the physician, either verbally or in writing. . . All verbal orders must be subsequently signed by the physician. 2. When a verbal order is received, the order must be written down, read back to verify order and receive confirmation from individual who gave order. A record of this order is documented on a physician's supplemental order form. . .3. The original order is submitted to the Agency within three (3) business days after receipt(s). The original order is mailed or taken to the physician for signature. A copy will remain in the patient's record until the signed order is returned and a copy will be placed in the tracking file (see Physician Orders and Tracking System Policy) . . ." Review of the undated policy titled "Physician Orders and Tracking System," obtained by the agency from the "Policies and Procedures Manual for Home Health Care 2000 MED-PASS, Inc. (Revised 2014)," indicated ". . . Physician orders are signed and returned to the Agency for placement in the patient's medical record within 30 – 60 days of the day they are written. . ." a. Review of P1's electronic medical record (EMR) indicated P1's "Home Health Certification and Plan of Care" for the certification period of 04/20/2022 to 06/18/2022, located under the "Orders" tab in the EMR, had not been signed by P1's physician. Further review indicated it had been more than 60 days since the order was received and written. b. Review of P2's EMR indicated physician orders, located under the "Orders" tab in the EMR and dated 04/11/2022 and 05/11/2022, had not been signed by P2's physician. P2's "Home Health Certification and Plan of Care" for the certification period of 05/11/2022 to 07/09/2022, located under the "Orders" tab in the EMR, had not been signed by P2's physician. Further review indicated it had been more than 60 days since the orders and the plan of care order had been received and written. c. Review of P4's EMR indicated a physician order, located under the "Orders" tab in the EMR and dated 04/08/2022, had not been signed by P4's physician. Further review indicated it had been more than 60 days since the order had been received and written. In an interview on 07/13/2022 at 2:00 PM, the Director of Nursing (DON) confirmed the physician order that was in P4's EMR dated 04/08/2022 had not been signed. In an interview on 07/14/2022 at 9:00 AM, the Administrative Assistant was responsible for getting physician orders and plans of care signed by the physician. The Administrative Assistant confirmed the above-listed physician orders and plans of care for P1, P2, and P5 had not been signed within 60 days of the orders being received. 2. Review of the undated policy titled "Physician Orders and Tracking System," obtained by the agency from the "Policies and Procedures Manual for Home Health Care 2000 MED-PASS, Inc. (Revised 2014)," indicated ". . . 1. The Agency will designate a person to be responsible for sending out orders, maintaining a tracking file and receiving the signed orders. . . 3. The original copy of the order is sent to the physician for signature. A copy will be maintained on the patient's medical record until the signed order is returned. 4. The tracking file is numbered 1 – 31, corresponding to the dates of the month. When an order is sent out, a copy of the order is placed in the number ten days after the date the order was written. 5. The tracking file is checked every day and if there are overdue orders in the file, the physician's office is called to verify if indeed the order was received and if a second copy needs to be sent. . . 6. When following up on a late order, document the action taken including the name of the person following up, the date and to whom spoken. 7. When signed orders are received in the office, the unsigned copies in the tracking file and on the patient's medical record are pulled. The signed copy then goes into the patient's medical record. 8. If the order has not been returned by the 20th day, a copy is placed in the appropriate file for the Director of Clinical Services (for further action) and the tracking copy is placed in the front of the tracking file. . ." Observation on 07/14/2022 at 9:00 AM revealed there was no tracking file that had been developed for tracking outstanding unsigned physician orders in accordance with the agency's policy. In an interview on 07/14/2022 at 9:00 AM, the Administrative Assistant confirmed the agency did not have a system in place to know which orders were outstanding and awaiting a physician's signature. The Administrative Assistant confirmed the agency did not have a tracking file developed like the one described in the agency's policy.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, policy review, and interview, the home health agency failed to provide the patient with a copy of the medication list for three of three patients (Patient (P)1, P2, P3) observed during home visits. The failure to provide the patient with a list of medications could result in medication errors and affect the health and well-being of all patients receiving home health services. Findings include: During a patient visit at the home of P1 on 07/13/2022 at 1:00 PM, Licensed Practical Nurse (LPN)1 was observed setting up P1's medication box and reviewing each medication by showing P1 each bottle and asking the time it was to be taken. During the visit P1's admission folder was reviewed, and it was noted that it did not include a list of P1's medications. The medication list provided prior to the visit was compared to the medications LPN1 was setting up in the medication boxes and noted discrepancies. When asked, LPN1 stated the medication list in the medical record must not have been updated. LPN1 confirmed P1 did not have a medication list provided by the HHA. During a patient visit at the home of P2 with Home Health Aide (HHA)1 on 07/14/2022 at 10:30 AM, revealed the agency admission folder did not include a medication list. P2 did not know where a medication list from the agency was. During a patient visit at the home of P3 with the Occupational Therapist (OT)1 on 07/14/2022 at 1:00 PM, revealed the agency admission folder did not include a medication list. P3 did not know if there was a medication list. OT1 did not know about a medication list but did open the folder each visit to document the patient vital signs. During an interview on 07/14/2022 at 2:00 PM, the Director of Nursing (DON) stated a list of the patient's current medication should be kept in the folder in the patient home and updated when there is a change in medications. Review of an agency policy titled, "Medication Reconciliation," dated 2014, "At time of admission, the admitting RN, PT, or SLP will create and document a complete list of medications that patient is taking at home, including dose, route, and frequency." The policy does not specifically address providing a copy to the patient at the time of admission as indicated in the regulation.

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 policy review, personnel file review, document review, and interview, the home health agency (HHA) failed to ensure the agency's COVID-19 vaccination policy contained all the required content, failed to ensure two staff members (Home Health Aide (HHA)2 and Registered Nurse (RN)1) of 15 staff member’s personnel files reviewed were fully vaccinated or had been granted an exemption, and the agency failed to implement their COVID-19 vaccination policy related to testing for staff who were not fully vaccinated. This deficient practice had the potential to affect the current 155 patients, all current staff, any future patient admitted to the HHA for home health services, and any future staff employed or contracted to provide home health services. Findings include: 1.Review of the undated policy titled "COVID-19 Vaccination of Home Health Agency staff," obtained by the agency from the "Policies and Procedures Manual for Home Health Care 2000 MED-PASS, Inc. [incorporated] (Revised 2014)," indicated ". . . 1. The Organization shall require employees to be fully vaccinated unless the employee falls into one of the following three categories: A. Those for whom vaccination is medically contraindicated. B. Those for whom medical necessity requires a delay in vaccination. C. Those who are legally entitled to a reasonable accommodation under federal civil rights laws because of a disability or sincerely held religious beliefs, practices or observances that conflict with the vaccination requirements. 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. . ." The agency policy, "COVID-19 Vaccination of Home Health Agency staff," did not include the following content required: a. The process for tracking and securely documenting the COVID-19 vaccination status of all staff. b. 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. c. A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law. d. 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. e. 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 (i) 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 (ii) 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. f. 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. In an interview on 07/14/2022 at 10:10 AM, the Office Manager confirmed the agency's COVID-19 vaccination policy did not include the above-listed processes. Review of the agency's list of staff with dates of each staff's COVID-19 vaccination indicated HHA2 had no date(s) listed as having received the COVID-19 vaccination. Review of RN1's "COVID-19 Vaccination Record Card" indicated RN1 received the first dose of the COVID-Moderna vaccine (two doses are required to be fully vaccinated) on 10/11/21. In an interview on 07/14/2022 at 10:10 AM, the Office Manager confirmed there was no documentation that HHA2 had received the COVID-19 vaccine. In an interview on 07/14/2022 at 11:15 AM, the Office Manager revealed RN1 informed the Office Manager that RN1 had a reaction after receiving the first dose of the Moderna vaccine. RN1 informed the Office Manager that RN1 would have to check with RN's doctor about further vaccination. The Office Manager had no documentation whether further vaccination had occurred for RN1. The Office Manager stated the agency did not have a process developed for staff to request medical exemptions. 2.Review of the undated policy titled "COVID-19 Vaccination of Home Health Agency staff," obtained by the agency from the "Policies and Procedures Manual for Home Health Care 2000 MED-PASS, Inc. [incorporated] (Revised 2014)," indicated ". . . 4. Each employee who is not fully vaccinated against COVID-19 shall submit to weekly COVID-19 testing. . . 7. If an employee does not provide documentation of a COVID-19 test result, the organization shall remove that employee from the workplace until the employee provides a test result. . ." Review of documentation of "Earnings Statement" for RN1 indicated RN1 worked from 10/17/2021 through 04/30/2022. There was no documentation of weekly COVID-19 testing being completed for RN1. Review of HHA2's "Employee Paystubs Report" indicated HHA2 worked from 05/01/2022 to 06/30/2022. There was no documentation of weekly COVID-19 testing being completed for HHA2. In an interview on 07/14/2022 at 11:25 AM, the Office Manager confirmed RN1 did not receive weekly COVID-19 testing during the time RN1 worked from 10/17/2021 through 04/30/2022 which was required by agency policy. In a telephone interview on 07/18/2022 at 5:57 PM, the Director of Nursing (DON) confirmed HHA2 did not receive weekly COVID-19 testing while the agency had no documentation that HHA2 was fully vaccinated.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on record review, policy review, and interview, the Home Health Agency (HHA) failed to monitor, manage, and maintain the equipment used to access the web-based electronic medical record (EMR). The use of staff owned personal computers and cell phones to access the EMR had the potential to compromise personal patient information and could affect all patients currently receiving services from the HHA, and all patients who have received past services. Findings include: Review of an agency policy titled, "Computer Key/Password," dated 2014 revealed, "At time of employment each individual who is authenticating medical record entries by computer will sign a statement that no one else will be allowed to use his/her computer key/password. This statement will be filed in the Agency's administrative offices. The individual employee is responsible for maintaining the security of his/her computer key/password.” On 07/13/2022 at 11:00 AM, surveyor was provided a log in and password to access the EMR and observed that it was possible to save the password and download patient information to the desktop. During an interview on 07/13/2022 at 1:00 PM, Licensed Practical Nurse (LPN)1 used a personal cell phone or computer at home to document patient information using the web based EMR. During an interview on 07/13/2022 at 2:45 PM the Director of Nursing (DON) stated it was the DON’s understanding that since the staff had to use a log-in and password to access the EMR and signed a confidentiality statement it would ensure security and meet the requirement for maintaining patient confidentiality. The DON confirmed the agency would not know if a staff person saved the password or downloaded patient information to their personal computer or cellphone.