Every finding on record at His Grace Home Healthcare, Inc

The Emergency Preparedness requirements were evaluated, in conjunction with the recertification survey, on 6/27/24. Standard level deficiencies cited.

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), §485.542(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, REHs at §485.542, 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 a review of the Emergency Preparedness plan and staff interview, it was determined that the Agency failed to conduct the required testing of its Emergency Preparedness plan. This has the potential to affect all patients receiving services from the Agency. Findings include: 1. The Agency's Emergency Preparedness plan was reviewed on 6/24/24. The plan lacked documentation that the Agency conducted or participated in a full-scale exercise, facility-based exercise, or activated the Agency's Emergency Preparedness plan since 2020. 2. During an interview with the Administrator and Director of Nursing on 6/26/24 at 11:30 AM, the Director of Nursing confirmed the above findings.

Recertification Survey conducted on 6/27/24. Standard level deficiencies cited. Abbreviations: MCG = Micrograms ACT = actuation MG = Milligrams AM = Morning PM = Afternoon OASIS = Outcome and Assessment Information Set

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on the review of the Error Summary report and staff interview, it was determined in 8 of 10 reports submitted for the last 12 months, the Agency failed to submit all timely reports, resulting in a warning. Findings include: 1. The Error Summary report for 3/1/23-2/28/24 was reviewed on 6/24/24 at 11:30 AM. The report included "error # -3330" for 8 of 10 late submissions, which was 80% of the OASIS reports submitted, were more than 30 days after the M0090. 2. During an interview with the Administrator and Director of Nursing on 6/26/24 at 1:30 PM, the Administrator confirmed that the error occurred.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on a review of clinical records, and staff interviews, it was determined in 3 of 3 (Patients. #1, 2, and 3) clinical records reviewed, the Agency failed to ensure patients were informed in writing of the frequency of visits provided by each discipline. Findings include: 1. The following clinical records were reviewed on 6/24/24 and 6/26/24: Patient #1. Start of care 3/13/24. Patient #2. Start of care 9/14/23. Patient #3. Start of care 9/14/23. Each record contained documentation that Patients #1, 2 and 3 recieved skilled nursing services only. The Agency's consent forms were signed by the patient, and dated the start of care date indicated above. During the initial visit, the Agency required the skilled nurse to enter the "Anticipated services and frequencies". The forms lacked the anticipated frequencies for the SN services. 2. During an interview with the Administrator and Director of Nursing conducted on 6/26/24 at 1:30 PM, the above findings were confirmed.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on record review, policy review and interview, it was determined that for 2 of 2 (Patients #2 and #3) closed clinical records reviewed, the Agency failed to ensure that the Plans of Care included all the medications ordered by the Physician. Findings include: 1. Patient #2 was admitted for skilled home health on 9/14/23 with the Diagnosis of Polyosteoarthritis. The clinical record was reviewed on 6/26/24 and included the document “Home Visit Encounter” which contained orders signed by the Physician on 9/5/23. Patient #2’s Plan of Care for the certification period of 9/14/23 to 11/12/23 lacked documentation of the following medications listed on the Physician Encounter note: Acetaminophen 500 MG – take 1 tablet by mouth every 6 hours as needed, Albuterol Sulfate 108 (90 Base) MCG/ACT Inhalation Aerosol Solution - 2 puffs inhaled orally every 6 hours as needed, Amlodipine Besylate 10 MG oral tablet - take one a day, Aspirin 81 MG tablet Delayed Release - take 1 tablet by mouth daily, Gabapentin 100 MG oral capsule - take 1 capsule by mouth twice daily, Lisinopril 20 MG oral tablet - take 1 table by mouth daily. 2. Patient #3 was admitted for skilled home health on 9/14/23 with the Diagnosis of Other Chronic Pain. The clinical record was reviewed on 6/26/24 and included the document “Home Visit Encounter” which contained orders signed by the Physician on 9/5/23. Patient #3’s Plan of Care for the certification period of 9/14/23 to 11/12/23 lacked documentation of the following medications listed on the Physician Encounter Note: Albuterol Sulfate 108 (90 Base) MCG/ACT Inhalation Aerosol Solution, use as directed, Budesonide-Formoterol Fumarate Dihydrate 160 -4.5 MCG/ACT Inhalation Aerosol, use as directed, Clopidogrel Bisulfate 75 MG oral tablet – take 1 tablet by mouth daily, Enalapril Maleate 20 MG oral tablet – take 2 tablets by mouth (40MG) daily, Sildenafil Citrate 100 MG oral tablet – take 1 tablet by mouth daily as needed, Tramadol Hydrochloride 50 MG oral tablet – take 1 tablet by mouth 2 times daily. 3. The Agency Policy “Drugs and Biologicals” was reviewed on 6/26/24 and required: “The agency will maintain guidelines for all patient drugs and biological agents through accurate information gathering, assessing, teaching, documenting, obtaining orders and reviewing the mediation regime…1. At the time of admission, the clinical shall document all current prescription and over the counter medications...” 4. During an interview with the Administrator and Director of Nursing conducted on 6/26/24 at 1:30 PM, the Director of Nursing stated that all medications that were ordered should be reflected on the Plan of Care. During the same interview, the above findings were confirmed.

Recertification and FIC Survey conducted on 6/10/21. 42 CFR 484.80 (f)(3): Eligible training and competency evaluating organizations. Determination has been made that this Agency is not in compliance with the Conditions of Participation for: 42 CFR 484.50 Patient Rights 42 CFR 484.70 Infection Prevention and Control 42 CFR 484.110 Clinical Records Therefore, the Agency is precluded from conducting aide training and/or competency evaluations for 24 months effective 6/10/21. This applies even if the agency is not currently conducting aide training and/or competency evaluation. Abbreviations: Pt./Pts. = Patient/Patients POC = Plan of Care SOC = Start of Care AM = Morning PM = Afternoon/Evening REC = Recertification ROC = Resumption of Care SUPV = Supervision RV = Re-Visit DC = Discharge PRN = As Needed PHI = Protected Health Information E = Employee SN = Skilled Nurse RN = Registered Nurse po = By Mouth BP = Blood Pressure MD = Medical Doctor > = Greater Than ML/ml = Milliters FBS = Fasting Blood Sugar RBS = Random Blood Sugar QV = Every Visit QW = Every Week HHCCN = Home Health Change of Care Notice MEQ = Milliequivalent cm = Centimeters IDPH = Illinois Department of Public Health COVID-19 = Coronavirus Disease 2019

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: . A. Based on a review of clinical records, staff interviews, IDPH Agency License Renewal application, observation and interview during home visit, Pt. admission folder review, Agency policy review, and staff interview, it was determined the Agency failed to ensure the Pt. is informed and/or participated in the frequency of visits provided by each discipline; failed to ensure confidentiality is maintained for documents, related to Pt. services; and failed to provide Pts. the Agency's policies relative to transfer and discharge. This has the potential to affect all Pts. that receive services from the Agency. Findings include: 1. In 1 of 7 clinical records reviewed, the Agency failed to ensure the Pt. is informed and/or participated in the frequency of visits provided by each discipline (G434). 2. The Agency failed to ensure confidentiality is maintained for documents, related to Pt. services (G438). 3. In 7 of 7 clinical records reviewed, the Agency failed to provide Pts. the Agency's policies relative to transfer and discharge (G452). The cumulative effect of these systemic practices resulted in Agency's inability to ensure Pts rights for confidentiality and care planning.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: . A. Based on a review of clinical records and staff interview, it was determined the Agency failed to ensure the Pt. is informed and/or participated in care. This was found in 1 of 7 (Pt. #1) clinical records reviewed. Findings Include: 1. Pt. #1. SOC 3/25/21. Primary Diagnosis: Primary Generalized (Osteo) Arthritis. The clinical record was reviewed on 6/7/21 at 2:40 PM. The record contained the form titled, "Admission Service Agreement" completed by the RN and dated 3/25/21. The form required the SN to document "Anticipated services and frequencies". This section lacked the service to be provided and the frequency, prior to providing Pt. care and services. 2. During an interview with the Administrator and Director of Nursing on 6/8/21 at 2:05 PM, the Administrator and Director of Nursing confirmed the above findings.

Have a confidential clinical record CFR(s): 484.50(c)(6) Have a confidential clinical record. Access to or release of patient information and clinical records is permitted in accordance with 45 CFR parts 160 and 164. This ELEMENT is not met as evidenced by: . A. Based on staff interview, IDPH Agency License Renewal application and Agency policy review, it was determined the Agency failed to ensure confidentiality is maintained for documents, related to Pt. services. This has the potential to affect all Pts. that receive services from the Agency. Findings include: 1. An interview was conducted with E #1( Licensed Practical Nurse) on 6/7/21 at 1:36 PM. During the interview, E #1 stated sometimes paperwork is dropped-off at the "...Medical Center. I drop-off paperwork... it is more convenient for me to go to... Medical Center verses the office." 2. An interview was conducted with the Administrator on 6/9/21 at 9:30 AM. During the interview the Administrator stated that completed "Patient Activity Log" forms are dropped-off at "... Medical Center". The "Patient Activity Log" form contained columns identifying: "Date, Patient Name, (Patient's) Signature, Type of Visit (SOC/REC/ROC/SUPV/RV/DC/PRN)" The Administrator stated the forms are picked-up by a courier not employed by the Agency. The Administrator stated, the courier drop-off the paperwork at the Agency during the operating hours (Monday through Friday, 9:00 AM to 5:00 PM). When the agency is closed, the courier drop-off the paperwork to "... Laboratory"(a nearby business), where the documents are kept until the Administrator pick-up the documents and take them to the Agency. As of 6/9/21, the Agency does not have a written contractual agreement with the courier, the Medical Center and/or Laboratory to address privacy and confidentiality of Agency documents pertaining to Pt. services. 3. The IDPH Agency's Licensure Renewal application, signed by the Administrator and dated 1/5/21 was reviewed on 6/7/21 at 11:00 AM. The application lacked any information pertaining to written contractual agreements for transporting and/or maintaining Pt. documents off-site. The application does not identify these locations as associated to the HHA. 4. The Agency policy titled, "Compliance With The Health Insurance Portability and Accountability Act" was reviewed on 6/10/21 at 9:46 AM. The policy required "...Confidentiality of Patient Information 1. The Agency will protect the Protected Health Information (PHI) of all patients. The agency shall take precautions to avoid improper... or inadvertent disclosures of ... records, or documents... 5. Disclosures of PHI outside the agency will be restricted to only authorized persons or entities..." 5. During an interview with the Administrator and Director of Nursing on 6/9/21 at 9:30 AM, the Administrator stated the Laboratory and the Medical Center are not authorized sites associated with the Agency. During the same interview the Administrator confirmed the Agency lacked a written contractual agreement with the Medical Center and Laboratory to handle/transport Pt. protected and confidential documents.

Transfer and discharge CFR(s): 484.50(d) Standard: Transfer and discharge. The patient and representative (if any), have a right to be informed of the HHA's policies for transfer and discharge. The HHA may only transfer or discharge the patient from the HHA if: This STANDARD is not met as evidenced by: . A. Based on review of the Agency's Pt. admission folder, clinical record review, observation and interviews during home visits, and patient/staff interview, it was determined the Agency failed to provide Pts. the Agency's policies relative to transfer and discharge. This was found in 7 of 7 (Pts. #1, 2, 3, 4, 5, 6 and 7) clinical records reviewed. Findings include: 1. The Agency's admission folder was reviewed on 6/7/21 at 10:15 AM. As of 6/7/21, the folder lacked information pertaining to the Agency's transfer and discharge policies. 2. The clinical records of the following Pts. were reviewed from 6/7/21 at 1:10 PM to 6/8/21 at 10:00 AM: Pt. #1. SOC 3/25/21. Pt. #2. SOC 2/17/21. Pt. #3. SOC 2/1/21. Pt. #4. SOC 1/11/21. Pt. #5. SOC 3/9/21. Pt. #6. SOC 10/14/20 Pt. #7. SOC 9/25/20. The records lacked information pertaining to the Agency's transfer and discharge policies. 3. The following home visits were conducted on 6/8/21 at 9:00 AM and 10:00 AM: Pt. #1. SOC 3/25/21. Pt. #2. SOC 2/17/21. Pt. #3. SOC 2/1/21. During the home visits, the Pt. admission folders were observed and lacked documentation of the Agency's transfer and discharge policies. During the same home visits, an interview was conducted with the Pts. that stated, they were not aware of the Agency's transfer and discharge policies. 4. During an interview with the Administrator and Director of Nursing on 6/8/21 at 2:05 PM and 6/9/21 at 10:30 AM, the Director of Nursing confirmed the Agency does not provide information to Pts. pertaining to transfer and discharge policies.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: . A. Based on clinical record review and staff interview, it was determined the Agency failed to follow the plan of care as ordered by the physician. This was found in 3 of 7 Pts. (Pts. #4, 5, and 6) clinical records reviewed. Findings include: 1. Pt. #4. SOC 1/11/21. Primary Diagnosis: Essential (Primary) Hypertension. The clinical record was reviewed on 6/8/21 at 12:00 PM. The record contained the POC for the certification period of 3/12/21 to 5/10/21, which contained the Physician's order "SN to notify MD for diastolic BP greater than (>) 90." The record also included the SN visit note dated 4/13/21, which documented Pt. #4's blood pressure was 141/97; however, the record lacked documentation Pt. #4's Physician was made aware of the 97 diastolic BP. 2. Pt. #5. SOC 3/9/21. Primary Diagnosis: Essential (Primary) Hypertension. The clinical record was reviewed on 6/7/21 at 2:00 PM. The record contained the POC effective 5/8/21, which contained the Physician's order "SN to notify MD for systolic BP greater than (>) 160...and diastolic BP greater than (>) 90." The record also included the SN visit note dated 6/1/21, which documented Pt. #5's BP was 181/98. The record also included the SN visit note dated 6/4/21, which documented Pt. #5's blood pressure was 180/82. The record lacked documentation Pt. #5's Physician was notified of the 6/1/21 or 6/4/21 blood pressure readings. 3. Pt. #6. SOC 10/14/20. Primary Diagnosis: Unspecified Atrial Fibrillation. The clinical record was reviewed on 6/8/21 at 2:10 PM. The record contained the POC effective 2/11/21, which contained the Physician's order "SN to notify MD for systolic BP greater than (>) 160...and diastolic BP greater than (>) 90." The record also included the SN visit note dated 2/13/21, which documented Pt. #6's blood pressure was 147/92. The record also contained the SN visit note dated 3/4/21, which documented Pt. #6's blood pressure was 155/96. The record also included the SN visit note dated 3/24/21, which documented Pt. #6's blood pressure was 155/97. The record also contained the SN visit note dated 3/31/21, which documented Pt. #6's blood pressure was 152/96. The record lacked documentation Pt. #6's Physician was notified of the 2/13/21, 3/4/21, 3/24/21, and 3/31/21 blood pressure readings. 4. During an interview with the Administrator and the Director of Nursing on 6/9/21 at 10:20 AM, the Director of Nursing confirmed the above findings, and stated the SN should notify the Physician when vital signs are not within the parameters set by the Physician, as required on the POC.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: . A. Based on clinical record review and staff interview, it was determined the Agency failed to ensure the POC contained relevant diagnosis, treatment and goals. This was found in 1 of 4 (Pt. #2) clinical records reviewed, whereas Diabetes management is required. Findings include: 1. Pt. #2. SOC 2/17/21. Primary Diagnosis: Primary Generalized (Osteo) Arthritis. The clinical record was reviewed on 6/7/21 at 3:40 PM. The record contained the SOC comprehensive assessment completed by the RN and dated 2/17/21; weekly SN visit notes from 3/1/21 to 4/7/21 and 4/20/21 to 5/26/21; and the recertification comprehensive assessment dated 4/14/21. The comprehensive assessments contained the Pt. has "Diabetes: Blood Sugars Performed By: Patient" with FBS results ranging from 171 to 225 and RBS results ranging from 135 to 227; Pt. requiring "Diabetic Management... Insulin Administration...by Patient". The weekly SN visit notes from 4/20/21 to 5/26/21 included the Pt. checks their own blood sugar with results ranging from 101 (FBS) to 240 (RBS). The POC for the certification period for 2/17/21 to 4/21/21 and POC effective 4/18/21 lacked a diagnosis of Diabetes, diabetes management/interventions, goals pertaining to Diabetes and Diabetes medication (insulin). 2. During an interview with the Administrator and Director of Nursing on 6/8/21 at 3:02 PM, the Administrator and Director of Nursing confirmed the PsOC for Pt. 2 were incomplete.

Influenza and pneumococcal vaccines CFR(s): 484.60(b)(2) Influenza and pneumococcal vaccines may be administered per agency policy developed in consultation with a physician, physician assistant, nurse practitioner, or clinical nurse specialist, and after an assessment of the patient to determine for contraindications. This ELEMENT is not met as evidenced by: . A. Based on clinical record review, and staff interview, it was determined the Agency failed to assess Pts. Influenza and Pneumococcal vaccine status at the SOC as per policy, and/or follow up with a Pt. request to receive the Influenza and Pneumococcal vaccines. This was found in 6 of 7 (Pts. #3, 4 5, 6, 1, and 2) records reviewed. Findings include: 1. Pt. #3. SOC 2/1/21. Diagnoses: Other Sequelae of Cerebral Infarction and Type 2 Diabetes Mellitus with Hyperglycemia. The clinical record was reviewed on 6/7/21 at 2:50 PM. The record lacked documentation Pt. #3 was assessed for the status of influenza and pneumococcal vaccines at the SOC. 2. Pt. #4. SOC 1/11/21. Primary Diagnosis: Essential (Primary) Hypertension. The clinical record was reviewed on 6/8/21 at 12:00 PM. The record lacked documentation Pt. #4 was assessed for the status of influenza and pneumococcal vaccines at the SOC. 3. Pt. #5. SOC 3/9/21. Primary Diagnosis: Essential (Primary) Hypertension. The clinical record was reviewed on 6/7/21 at 2:00 PM. The record contained documentation that at the SOC, Pt. #5 requested to receive both the Influenza and Pneumococcal vaccines. The record lacked documentation Pt. #5 received these vaccines, or was referred to a Physician or other source who could administer these vaccines. 4. Pt. #6. SOC 10/14/20. Primary Diagnosis: Unspecified Atrial Fibrillation. The clinical record was reviewed on 6/8/21 at 2:10 PM. The record lacked documentation Pt. #6 was assessed for the status of influenza and pneumococcal vaccines at the SOC. 5. Pt. #1. SOC 3/25/21. Primary Diagnosis: Primary Generalized (Osteo) Arthritis. The clinical record was reviewed on 6/7/21 at 2:40 PM. The record contained the SOC comprehensive assessment completed by the RN and dated 3/25/21. The assessment lacked an Influenza and Pneumococcal Pneumonia vaccine inquiry, as required by the Agency. 6. Pt. #2. SOC 2/17/21. Primary Diagnosis: Primary Generalized (Osteo) Arthritis. The clinical record was reviewed on 6/7/21 at 3:40 PM. The record contained the SOC comprehensive assessment completed by the RN and dated 2/17/21. The assessment lacked an Influenza and Pneumococcal Pneumonia vaccine inquiry. 7. During an interview with the Administrator and Director of Nursing on 6/8/21 at 2:05 PM and 6/9/21 at 10:30 AM, the Director of Nursing confirmed Agency staff failed to assess Pts. for the Influenza and Pneumococcal Pneumonia vaccines at the SOC and/or follow-up with the Patient's request to receive the vaccines. The Director of Nursing stated the RN should assess the Patient's Influenza and Pneumococcal vaccine status at the SOC. This should then be documented in the Patient's medical record. If the Pt. requests to receive the Influenza vaccine, the Agency SN can administer it. If the Pt. requests to receive the pneumococcal vaccine, the Pt. is referred to their Physician for follow up. This should also be documented in the Patient's medical record.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: . A. Based on clinical record review, observation and interview during a home visit, Agency policy review and staff interview, it was determined the Agency failed to ensure the Physician was notified regarding changes in the patient's condition that may warrant a change in the POC. This was found in 4 of 7 (Pt.#1, #4, #5 and #6) clinical records reviewed. Findings include: 1. Pt. #1. SOC 3/25/21. Primary Diagnosis: Primary Generalized (Osteo) Arthritis. The clinical record was reviewed on 6/7/21 at 2:40 PM. The record contained the SN recertification comprehensive assessment completed by the RN and dated 5/20/21. The assessment contained a section titled "Integumentary Status" which included "skin intact". The next SN (RN) visit was conducted on 5/27/21, the SN visit note included documentation the Pt. had developed a skin lesion/wound measured at 3.5 cm by 1 cm to the right leg, and a skin lesion to the left toe measured at 1 cm by 0.5 cm. The SN cleaned the wounds with "normal saline". A home visit was conducted with the DON on 6/8/21 at 10:00 AM. During the home visit, observed an ace bandage to the left lower leg and an interview was conducted with the Pt. that stated, "The doctor said I don't have to change it every day, so I change it every 1 to 1 1/2 days... the nurse change it when she is here...we clean it with normal saline, put Silvadene cream on it, cover it with dry bandages and ace bandage." The SN visit note dated 5/27/21 and/or the record lacked documentation the SN notified the Physician that the Pt. developed wounds to the bilateral extremities, until 6/4/21 when the RN wrote the Physician order: "Please schedule wound Doctor visit for assessment of both legs..." 2. Pt. #4. SOC 1/11/21. Primary Diagnosis: Essential (Primary) Hypertension. The clinical record was reviewed on 6/8/21 at 12:00 PM. The record contained the POC for the certification period of 3/12/21 to 5/10/21, which contained the Physician's order "SN to notify MD for diastolic BP greater than (>) 90." The record also included the SN visit note dated 4/13/21, which documented Pt. #4's blood pressure was 141/97; however, the record lacked documentation Pt. #4's Physician was made aware of the 97 diastolic BP. 3. Pt. #5. SOC 3/9/21. Primary Diagnosis: Essential (Primary) Hypertension. The clinical record was reviewed on 6/7/21 at 2:00 PM. The record contained the POC effective 5/8/21, which contained the Physician's order "SN to notify MD for systolic BP greater than (>) 160...and diastolic BP greater than (>) 90." The record also included the SN visit note dated 6/1/21, which documented Pt. #5's BP was 181/98. The record also included the SN visit note dated 6/4/21, which documented Pt. #5's blood pressure was 180/82. The record lacked documentation Pt. #5's Physician was notified of the 6/1/21 or 6/4/21 blood pressure readings. 4. Pt. #6. SOC 10/14/20. Primary Diagnosis: Unspecified Atrial Fibrillation. The clinical record was reviewed on 6/8/21 at 2:10 PM. The record contained the POC effective 2/11/21, which contained the Physician's order "SN to notify MD for systolic BP greater than (>) 160...and diastolic BP greater than (>) 90." The record also included the SN visit note dated 2/13/21, which documented Pt. #6's blood pressure was 147/92. The record also contained the SN visit note dated 3/4/21, which documented Pt. #6's blood pressure was 155/96. The record also included the SN visit note dated 3/24/21, which documented Pt. #6's blood pressure was 155/97. The record also contained the SN visit note dated 3/31/21, which documented Pt. #6's blood pressure was 152/96. The record lacked documentation Pt. #6's Physician was notified of the 2/13/21, 3/4/21, 3/24/21, and 3/31/21 blood pressure readings. 5. The Agency policy titled, "Medial Supervision" was reviewed on 6/8/21 at 4:00 PM. The policy required: "...7. The Agency provides for the physician... c. Timely notification of change in condition..." 6. During an interview with the Administrator and Director of Nursing on 6/8/21 at 2:05 PM, the Director of Nursing confirmed the RN failed to notify the Physician regarding changes in the patient's condition 7. During an interview with the Administrator and the Director of Nursing on 6/9/21 at 10:20 AM, the Director of Nursing confirmed the above findings, and stated the SN should notify the Physician when vital signs are not within the parameters set by the Physician, as required on the POC.

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: . A. Based on a review of clinical records, Agency In-Service, Agency reports and staff interview, it was determined the Agency failed to ensure staff screened Pts. for COVID-19 signs and symptoms prior to providing Pt. care and services; establish a complete Infection Control Surveillance Program relative to COVID-19 that included policies relative to COVID-19 surveillance, Pt. and Physician notification of suspected/confirmed exposure to COVID-19. This has the potential to affect all Pts. who receives services provided by the Agency. Findings include: 1. In 7 of 7 clinical records reviewed, the Agency failed to ensure staff screened Pts. for COVID-19 signs and symptoms (G682). 2. In 1 of 1 closed clinical record reviewed of a Pt. tested COVID-19 positive, the Agency failed to establish a complete Infection Control Surveillance Program relative to COVID-19 that included policies relative to COVID-19 surveillance, Pt. and Physician notification of suspected/confirmed exposure of COVID-19 (G684). The cumulative effect of these systemic practices resulted in the Agency's inability to ensure infection control practices and prevention was maintained by the staff.

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: . A. Based on a review of clinical records, Agency In-Service, and staff interview, it was determined the Agency failed to ensure staff screened Pts. for COVID-19 signs and symptoms prior to providing Pt. care and services. This was found in 7 of 7 (Pts. #3, 4, 5, 6, 1, 2, and 7) clinical records reviewed. Findings include: 1. Pt. #3. SOC 2/1/21. Diagnoses: Other Sequelae of Cerebral Infarction and Type 2 Diabetes Mellitus with Hyperglycemia. The clinical record was reviewed on 6/7/21 at 2:50 PM. The record contained documentation the SN provided service to Pt. #3 on 5/28/21. The record lacked documentation Pt. #3 was screened for signs and symptoms of COVID-19 prior to this visit. The record included documentation the Home Health Aide provided service to Pt. #3 twice weekly from 4/12/21 to 6/4/21. The record lacked documentation the Home Health Aide screened Pt. #3 for signs and symptoms of COVID-19 prior to these visits. The record contained documentation the PT and PTA provided service on 4/16/21, 4/21/21, 4/23/21, 4/26/21, 5/3/21, 5/5/21, and 5/15/21. The record lacked documentation the PT and PTA screened Pt. #3 for signs and symptoms of COVID-19 prior to these visits. 2. Pt. #4. SOC 1/11/21. Primary Diagnosis: Essential (Primary) Hypertension. The clinical record was reviewed on 6/8/21 at 12:00 PM. The record contained documentation the SN provided service on 5/7/21. The record lacked documentation the SN screened Pt. #4 for signs and symptoms of COVID-19 prior to this visit. 3. Pt. #5. SOC 3/9/21. Primary Diagnosis: Essential (Primary) Hypertension. The clinical record was reviewed on 6/7/21 at 2:00 PM. The record contained documentation the SN provided weekly service from 4/20/21 to 5/18/21. The record lacked documentation the SN screened Pt. #5 for signs and symptoms of COVID-19 prior to these visits. 4. Pt. #6. SOC 10/14/20. Primary Diagnosis: Unspecified Atrial Fibrillation. The clinical record was reviewed on 6/8/21 at 2:10 PM. The record contained documentation the SN provided service on 2/10/21 and 4/8/21. The record lacked documentation the SN screened Pt. #6 for signs and symptoms of COVID-19 prior to these visits. The record included documentation the PT provided service on 2/17/21, 2/22/21, 2/24/21, 3/3/21, 3/5/21, and 3/8/21. The record lacked documentation the PT screened Pt. #6 for signs and symptoms of COVID-19 prior to these visits. 5. Pt. #1. SOC 3/25/21. Primary Diagnosis: Primary Generalized (Osteo) Arthritis. The clinical record was reviewed on 6/7/21 at 2:40 PM. The record contained the SN recertification comprehensive assessment dated 5/20/21, indicating service was provided. The record lacked documentation the SN screened the Pt. for COVID-19 symptoms, prior to the visit indicated above, as required by the Agency. 6. Pt. #2. SOC 2/17/21. Primary Diagnosis: Primary Generalized (Osteo) Arthritis. The clinical record was reviewed on 6/7/21 at 3:40 PM. The record contained the SN visit notes dated 5/19/21 and 5/26/21, indicating service was provided. The record lacked documentation the SN screened the Pt. for COVID-19 symptoms, prior to the visits indicated above. 7. Pt. #7. SOC 9/25/20. Primary Diagnosis: COVID-19. The closed clinical record was reviewed on 6/7/21 at 1:10 PM. The record contained the SOC comprehensive assessment completed by the SN and dated 9/25/20; SN visit notes dated 10/6/20, 10/13/20 and 10/27/20, indicating service was provided. The record lacked documentation the SN screened the Pt. for COVID-19 symptoms, prior to the visits indicated above. 8. The Agency's In-service dated 4/27/21 which included: "Agenda - Continue with COVID-19 prescreening before you arrive to your patient's home. Has the patient or anyone in the family (household) tested positive for COVID-19?..." 9. During an interview with the Administrator and Director of Nursing on 6/8/21 at 3:02 PM, the Director of Nursing stated: "Field staff ask the screening questions before entering the patient's home and include the findings in their narrative." During the same interview, the Administrator and the Director of Nursing confirmed staff failed to screen Pts. for COVID-19, prior to providing Pt. care and service.

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: . A. Based on clinical record review, review of the Agency reports and staff interview, it was determined the Agency failed to establish a complete Infection Control Surveillance Program relative to COVID-19 that included, policies relative to COVID-19 surveillance, Pt. and Physician notification of suspected/confirmed exposure to COVID-19. This was found in 1 of 1 (Pts. #7) closed clinical records reviewed, wherein the Pt. tested COVID-19 positive, and this has the potential to affect all Pts. who receives services provided by the Agency. Findings include: 1. Pt. #7. SOC 9/25/20. Primary Diagnosis: COVID-19. The closed clinical record was reviewed on 6/7/21 at 1:10 PM. The record contained documentation that E #2 provided service to the Pt. on 11/3/20. The Pt. was transferred to an inpatient facility on 11/8/20 with a diagnosis of COVID-19. As of 6/7/21, the Agency lacked any documentation of COVID-19 surveillance of E #2 due to the exposure to COVID-19. 2. The report titled "COVID-19 Case" included 3 Pts. that tested COVID-19 positive. This form was reviewed on 6/7/21 at 1:00 PM and contained documentation that E#2 provided service to Pt #7 on 11/3/20. On 11/8/20, E #2 received a phone call to report Pt. #7 was hospitalized and tested COVID-19 positive. The Agency lacked any documentation of COVID-19 surveillance of E #2 and Pt. #7 exposure to COVID-19. 3. The report dated "06/08/2021" included the name of E #2 and documentation that E #2 provided service to fourteen (14) Pts. from 11/2/20 to 11/13/20. The Agency lacked any documentation that E #2 self-quarantine, Pts. were notified of their potential exposure to COVID-19, surveillance of the 14 Pts. potentially exposed to COVID-19, or the patient's Physicians were notified regarding the potential exposure to COVID-19. 4. As of 6/7/21, the Agency lacked any policies pertaining to COVID-19 surveillance for staff and Pts. 5. During an interview with the Administrator and Director of Nursing on 6/8/21 at 2:05 PM, the Administrator and Director of Nursing confirmed the Agency lacked surveillance of staff exposed to COVID-19, and COVID-19 surveillance policies.

Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient's condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA's policies and procedures. This ELEMENT is not met as evidenced by: . A. Based on clinical record review, Agency policy, and staff interview, it was determined the Agency failed to ensure the Home Health Aide report Pt. refusals of care tasks to the RN. This was found in 1 of 1 (Pt. #3) Pt., wherein Home Health Aide services were provided. Findings include: 1. Pt. #3. SOC 2/1/21. Diagnoses: Other Sequelae of Cerebral Infarction and Type 2 Diabetes Mellitus with Hyperglycemia. The clinical record was reviewed on 6/7/21 at 2:50 PM. The record included the Home Health Aide Care Plan dated 4/2/21 to 5/31/21, and the Home Health Aide Care Plan dated 6/1/21 to 7/30/21. Both of these care plans contained the instructions for "oral care QV, shampoo hair QW, and hair comb/hair brush QV." The record contained twice weekly Home Health Aide visit notes from 4/12/21 to 6/4/21. These notes included documentation Pt. #3 refused oral care on 4/15/21, 4/22/21, 4/26/21, 4/29/21, 5/3/21, 5/6/21, 5/10,21, 5/13/21, 5/17/21, 5/20/21, 5/24/21, and 5/27/21. The notes also contained documentation Pt. #3 refused a weekly shampoo for the weeks of 5/9/21 to 5/15/21, 5/16/21 to 5/22/21, and 5/23/21 to 5/27/21. The notes also included documentation Pt. #3 refused a hair comb/hair brush on 5/24/21, 5/27/21. These notes lacked documentation under the "comments" section as to why Pt. #3 refused these tasks, or that the Nurse was notified of Pt. #3's refusal. 2. The Agency policy titled " Home Health Aide Documentation" was reviewed on 6/8/21 at 1:45 PM. The policy required: "...The Home Health Aide shall follow the care plan left in the patient's home when providing all patient care services and observations...If a patient refuses an ordered service, the Home Health Aide shall indicate this in the comments section...The Registered Nurse Case Manager and the Nursing Supervisor will review the Home Health Aide documentation to assure that the care plan is being followed..." 3. During an interview with the Administrator and the Director of Nursing on 6/9/21 at 10:30 AM, the Director of Nursing stated that if a pt. refuses a task listed on the Home Health Aide Care Plan, the Home Health Aide should document the reason on the "comments" section of the visit note, and notify the patient's Nurse. Quality Assurance reviews Home Health Aide documentation. If a patient is consistently refusing certain tasks, The Home Health Aide Care Plan is then changed by the RN case manager accordingly.

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: . A. Based on clinical record review, observations and interviews during home visits, Agency policy review and staff interview, it was determined the Agency failed to ensure the medications listed in the clinical record were complete and accurate; forward a copy of the discharge summary to the physician; ensure clinical record documentation was complete and/or accurate; and prevent unauthorized access of Pt. information. This has the potential to affect all Pts. that receive services from the Agency. Findings Include: 1. In 3 of 7 clinical records reviewed, the Agency failed to ensure the medications listed in the clinical record were complete and accurate (G1014). 2. In 1 of 2 closed clinical records reviewed, the Agency failed to forward a copy of the discharge summary to the Physician (G1022). 3. In 2 of 7 clinical records reviewed, the Agency failed to ensure clinical record documentation was complete and/or accurate (G1024). 4. The Agency failed to prevent unauthorized access of Pt. information (G1028). The cumulative effect of these systemic practices resulted in Agency's inability to maintain accuracy and protection of clinical records, and to ensure physicians receive a Pt. discharge summary.

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: . A. Based on clinical record reviews, observation and interviews during home visits, Agency policy review and staff interview, it was determined the Agency failed to ensure the medications listed in the clinical record were complete and accurate. This was found in 3 of 7 (Pts. #1, 2, and 3) clinical records reviewed. Findings include: 1. Pt. #1. SOC 3/25/21. Primary Diagnosis: Primary Generalized (Osteo) Arthritis. The clinical record was reviewed on 6/7/21 at 2:40 PM. The record contained the "Medication Profile" form completed by the RN for the certification period effective 5/24/21. The form contained: "Omeprazole 40 MG oral delayed release capsule 1 tab daily, Tramadol 50 mg twice a day as needed for pain po, Lisinopril 20 MG oral tablet 1 tab daily po, Fluticasone 0.5 MG/2 ML inhalation suspension 1 spray daily po." A home visit was conducted with the Director of Nursing on 6/8/21 at 10:00 AM. During the home visit, the patient's medications were observed and an interview was conducted with Pt. #1 that included: Omeprazole 40 MG oral delayed release capsule 1 tab is taken two times a day (not daily), the Pt. stated she had taken Omeprazole "two times a day for years"; Tramadol was discontinued 1 1/2 years ago; Lisinopril 20 MG oral tablet 1 tablet is taken two times a day (not daily), the prescription bottle was dated 4/29/21, the Pt. stated she had taken Lisinopril "twice a day for years"; Fluticasone 0.5 MG/2 ML inhalation suspension 1 spray is taken as needed (not daily), the Pt. stated she had taken Fluticasone "as needed for years". Other medications were observed, but not included on the Medication Profile: Humulin 70/30 20 units every morning subcutaneous (Pt. stated "taken for years"), Collagen 1000 mg tablets take 3 tablets daily po (Pt. stated "taken for the past 1 1/2 months), Levocetirizine Dihyd 5 mg per tablet take 1 tablet po daily at night as needed (Pt. stated "taken for quite a while"). Pt. #1 stated, the RN was aware of the current medications, and how often they are taken. As of 6/7/21, the Medication Profile for Pt. #1 was inaccurate. 2. Pt. #2. SOC 2/17/21. Primary Diagnosis: Primary Generalized (Osteo) Arthritis. The clinical record was reviewed on 6/7/21 at 3:40 PM. The record contained the "Medication Profile" form completed by the RN for the certification period effective 4/18/21. The form contained: Metolazone 2.5 mg Oral Tablet 1.5 Take 1.5 tablet by mouth every other day By mouth (PO), Potassium Chloride 20 MEQ/15 ML oral liquid 7.5 ml Take one time daily By mouth (PO), Lasix 80 mg 1 tab daily By mouth (PO), Pantoprazole 40 MG Oral Delayed Release Tablet 1 cap daily By mouth (PO), Metolazone 2.5 MG Oral Tablet weekly By mouth (PO), Vitamin D3 5000 INTL Units (125 MCG) Oral Tablet Take one tablet daily By mouth (PO). A home visit was conducted with the E #1 on 6/8/21 at 9:00 AM. During the home visit, the patient's medications were observed with E #1, and interviews were conducted with Pt. #1 and E #1 which included: The Metolazone 2.5 mg Oral Tablet 1.5 Take 1.5 tablet by mouth every other day was discontinued "about 3 to 4 weeks ago; Potassium Chloride 20 MEQ/15 ML, Pt. takes 15 ml (not 7.5 ml) daily; Lasix 80 mg is taken 2 times a day since 2005 (not daily), Pantoprazole was discontinued in 2020, Metolazone 2.5 MG Oral Tablet weekly is taken only as needed, Vitamin D3 5000 INTL Units was discontinued about 4 to 5 months ago. The medication "Montelukast 10 mg take 1 tablet by mouth every day was observed. This medication was not included on the Medication Profile. The date on the prescription bottle was 5/11/21. E#1 stated "I'm aware" of the patient's current medications and dosages listed above. 3. Pt. #3. SOC 2/1/21. Diagnosis: Other Sequelae of Cerebral Infarction and Type 2 Diabetes Mellitus with Hyperglycemia. The clinical record was reviewed on 6/7/21 at 2:50 PM. The record included a Medication Profile, completed by the RN for the certification period effective 6/1/21. A home visit was conducted on 6/8/21 at 10:00 AM, along with E #3. During this home visit, Pt. #3's Caregiver presented Pt. #3's medications, which were observed and compared to Pt. #3's Medication Profile. Pt. #3's Caregiver presented a bottle of Bethanechol Chloride 25 mg tablets, which contained the instruction to take 2 tablets (50 mg) three times daily, 1 hour before or 2 hours after meals. Pt. #3's Caregiver then presented a bottle of Escitalopram 10 mg, which contained the instruction to take one tablet daily. Both the Bethanechol Chloride and the Escitalopram where not listed on Pt. #3's Medication Profile, although Pt. #3's Caregiver stated Pt. #3 had been taking both of these medications "for 2 to 3 years." Pt. #3's Caregiver also presented a bottle of Ibuprofen 600 mg tablets, which included the instruction to take one tablet three times a day, as needed. Ibuprofen was not listed on Pt. #3's Medication Profile, although Pt. #3's Caregiver stated Pt. #3 has been taking this medication "for a year and a half." Pt. #3's Medication Profile also contained a Physician's order for Tresiba Insulin 10 units subcutaneous by injection daily. Pt. #3's Caregiver stated Pt. #3 is given 10 units daily only if Pt. #3's blood glucose level is below 174, and if Pt. #3's blood sugar level is 175-200, then 20 units subcutaneous is administered to Pt. #3. If Pt. #3's blood sugar level is above 200, then Pt. #3's Caregiver is to call Pt. #3's Physician. Pt. #3's Caregiver stated Pt. #3 has been on this Tresiba dosing protocol "for quite awhile." The Medication Profile was inaccurate. 4. The Agency policy titled "Drugs and Biologicals" was reviewed on 6/8/21 at 12:30 PM. The policy required: "The Agency will maintain guidelines for all Patient drugs and biologicals through accurate information gathering, assessing, teaching, documenting, obtaining orders, and reviewing the medication regime...The clinician will review all medications with the Patient...If Patients do not have an ordered medication, the clinician shall notify the Physician..." 5. During interviews with the Administrator and Director of Nursing on 6/8/21 at 2:05 PM and on 6/9/21 at 10:30 AM, the Director of Nursing confirmed the Medication Profiles of the above Pts. were inaccurate, and stated if a Pt. reports a change in medication, the SN should notify the Physician. Any new orders are then written, and the Patient's Medication Profile is updated with the changes.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: . A. Based on clinical record review and staff interview, it was determined the Agency failed to forward a copy of the discharge summary to the Physician. This was found in 1 of 2 (Pt. #7) closed clinical records reviewed. Findings include: 1. Pt. #7. SOC 9/25/20. Primary Diagnosis: COVID-19. The closed clinical record was reviewed on 6/7/21 at 1:10 PM. The record contained the Agency's "SN Discharge Summary" completed by the RN and dated 3/23/21. The form included documentation the Agency had discharged the Pt. The form/record lacked documentation a copy of the "Discharge Summary" was sent to the Physician. 2. During an interview with the Administrator and Director of Nursing on 6/8/21 at 3:02 PM, the Director of Nursing confirmed a copy of the Agency's discharge summary was not sent to the Physician.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: . A. Based on clinical record reviews, Agency policy, and staff interview, it was determined the Agency failed to ensure clinical record documentation was complete and/or accurate. This was found in 2 of 7 (Pts. #5 and 1) records reviewed. Findings include: 1. Pt. #5. SOC 3/9/21. Primary Diagnosis: Essential (Primary) Hypertension. The clinical record was reviewed on 6/7/21 at 2:00 PM. The record contained a document titled "Home Health Change of Care Notice (HHCCN)," which was signed by Pt. #5 on 3/9/21, indicating that on 3/9/21, "Your home health care is going to change." The sections "Items/services," and "Reason for change," as well as "Your home health Agency is giving you this information" were all left blank. The record included a document titled "Request for Transfer of Home Health Services," signed by Pt. #5 on 3/9/21. The Agency Pt. #5 was being transferred from was left blank. 2. Pt. #1. SOC 3/25/21. Primary Diagnosis: Primary Generalized (Osteo) Arthritis. The clinical record was reviewed on 6/7/21 at 2:40 PM. The record contained the form titled, "Request For Transfer Of Home Health Services" dated 3/25/21 and signed by the Pt. This form was left blank. The form lacked the name of the Agency that previously provided care and/or service, as required by the Agency's form. 3. The Agency policy titled, "Clinical Records" was reviewed on 6/9/21 at 11:15 AM. The policy required"...Purpose To ensure that a complete and accurate record of patient care is maintained..." 4. During an interview with the Administrator and Director of Nursing on 6/8/21 at 3:02 PM and 6/9/21 at 10:30 AM, the Administrator and Director of Nursing confirmed the clinical records were incomplete.

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: . A. Based on staff interview, and policy review, the Agency failed to prevent unauthorized access of Pt. information. This has the potential to affect all Pts. that receive services from the Agency. Findings Include: 1. An interview was conducted with E #1 on 6/7/21 at 1:36 PM. During the interview, E #1 stated sometimes paperwork is dropped-off at the "...Medical Center. I drop-off paperwork... it is more convenient for me to go to... Medical Center verses the office." 2. An interview was conducted with the Administrator on 6/9/21 at 9:30 AM. During the interview the Administrator stated that completed "Patient Activity Log" forms are dropped-off at "... Medical Center". The Administrator stated the forms are picked-up by a courier not employed by the Agency. The Administrator stated, the courier drop-off the paperwork at the Agency during the operating hours. When the agency is closed, the courier drop-off the paperwork to "... Laboratory"(a nearby business), where the documents are kept until the Administrator pick-up the documents and take them to the Agency. As of 6/9/21, components of the clinical record was accessed by unauthorized individuals. 3. The Agency policy titled, "Compliance With The Health Insurance Portability and Accountability Act" was reviewed on 6/10/21 at 9:46 AM. The policy required "...Confidentiality of Patient Information 1. The Agency will protect the Protected Health Information (PHI) of all patients. The agency shall take precautions to avoid improper... or inadvertent disclosures of ... records, or documents... 5. Disclosures of PHI outside the agency will be restricted to only authorized persons or entities..." 4. During an interview with the Administrator and Director of Nursing on 6/9/21 at 9:30 AM, the Administrator confirmed the above findings.