Every finding on record at Good Neighbor HHC of Brainerd

A survey for compliance with CMS Appendix Z Emergency Preparedness Requirements, was conducted on 12/16/24 and 12/17/23, during a recertification survey. The facility is in compliance with the Appendix Z Emergency Preparedness Requirements.

On 12/16/24 and 12/17/24, a recertification survey was conducted. This resulted in a partial extended survey at Goon Neighbor HHC of Brainerd. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure provision of quality of care. Unduplicated census previous 12 months: 149 Total home visits conducted: 03 List Parent Location visit. Good Neighbor HHC of Brainerd 7111 Forthun Drive STE 100 Baxter MN 56425 No Branch Offices List Hours of Operation: 8:00 a.m. - 4:30 p.m. List total number of records reviewed: 07

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 interview and document review the agency failed to encode and electronically transmit completed OASIS assessments to the Center of Medicare and Medicaid (CMS) system within 30 days of completing the assessment of the patient for 9 of 9 (P1, P2, P3, P4, P5, P6, P7, P8, P9) patients reviewed. The Center of Medicare and Medicaid (CMS) Outcome and Assessment Information Set (OASIS) Error Detail Report dated 1/1/24 through 12/12/24, identified eleven patients whose OASIS assessment records were submitted more than 30 days after the assessment had been completed. P1's plan of care (POC) identified a start of care date (SOC) of 9/22/23. P1's recertification OASIS assessment with completion date 5/15/24, was submitted to CMS 6/18/24, 34 days after completion of the assessment. P2's POC identified a SOC date of 5/16/24. P2's start of care OASIS assessment with completion date 5/16/24, was submitted to CMS 6/18/24, 33 days after completion of the assessment. P3's POC identified a SOC of 5/25/23. P3's recertification OASIS assessment with completion date 5/16/24, was submitted to CMS 6/18/24, 33 days after completion of the assessment. P4's POC identified a SOC of 2/14/24. P4's discharge OASIS assessment with completion date 5/22/24, was submitted to CMS 7/3/24, 42 days after completion of the assessment. P5's POC identified a SOC of 7/31/24. P5's discharge OASIS assessment with completion date 8/07/24, was submitted to CMS 9/11/24, 35 days after completion of the assessment. P6's POC identified a SOC of 7/31/24. P6's discharge OASIS assessment with completion date 8/07/24, was submitted to CMS 9/11/24, 35 days after completion of the assessment. P7's POC identified a SOC of 3/09/23. P7's discharge OASIS assessment with completion date 8/23/24, was submitted to CMS 9/25/24, 33 days after completion of the assessment. P8's POC identified a SOC of 1/23/23. P8's recertification OASIS assessment with completion date 9/13/24, was submitted to CMS 10/28/24, 45 days after completion of the assessment. P9's POC identified a SOC date of 10/15/24. P9's start of care OASIS assessment with completion date 10/15/24, was submitted to CMS 11/18/24, 34 days after completion of the assessment. During interview on 2/17/24 at 1:30 p.m. licensed practical nurse (LPN)-A stated she thought she needed to submit the agency completed OASIS assessments more than the two days monthly she currently had the task scheduled for. Holidays in the month interfered with submission dates and there were also times the agency nurses did not complete the assessment in a timely manner and that caused late submissions as well. During interview on 2/17/24, at 3:00 p.m. registered nurse (RN)-A stated LPN-A may need to change to submitting the OASIS assessments weekly to ensure they were submitted in the required time frame. The Center for Medicare and Medicaid Services OASIS E Manual, updated 1/1/24, identified OASIS data was collected as part of the comprehensive assessment required by the Medicare Conditions of Participation. The CMS Home Health Conditions of Participation required a home health agency electronically transmit accurate, completed, and encoded OASIS data to a centralized data submission system within 30 days of the completion of the assessment (M0090 Date Assessment Completed).

Laboratory services/CLIA waivers CFR(s): 484.100(c)(1) Laboratory services. If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient's equipment when assisting with self-administered tests. This STANDARD is not met as evidenced by: Based on observation, interview and document review, the facility failed to maintain a CLIA waiver and continued to engage in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration. This affected 11 patients who received laboratory services. During an observation on 12/17/24 at 2:22 p.m., a Centers for Medicare and Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver with an expiration date of 9/30/24 was mounted in a frame on a bookshelf in the conference room. An agency provided handwritten list undated, identified 11 patients received venipuncture (blood draw) and international normalized ratio (INR) (a standardized number that's figured out in the lab and measure the time it takes for blood to clot) from the agency. During an interview on 12/17/24 at 2:30 p.m., the clinical manager (CM)-A stated the agency did collect patient blood draws and patient INR, however, brought the samples to the lab to be performed. Shirley and Sara stated they did not apply for a new CLIA waiver because they did not have a lab. Because of this, the agency did not believe they needed a CLIA waiver and did not re-apply. The agency policy Venipunctures undated, identified venipuncture was a technique in which a vein was punctured transcutaneously with a butterfly needle, a needle attached to a syringe or a vacutainer for the purpose of obtaining a blood specimen. The agency Preanalytic Policies and Procedures undated, identified it was the policy of the anticoagulation testing program to adhere to the following procedures, which govern all activities from the time tests were ordered through the time specimens were received and processed at the testing site. A policy and/or procedure regarding the application of a CLIA waiver was requested but not received.

A survey with CMS Appendix Z Emergency Preparedness Requirements, was conducted on 4/25/22 to 4/28/22, during a recertification survey. The facility is NOT in compliance with the Appendix Z Emergency Preparedness Requirements.

HHA- Procedures for Follow up Staff/Pts. CFR(s): 484.102(b)(3) §484.102(b)(3) Condition of Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. This STANDARD is not met as evidenced by: Based on interview and policy review, the facility failed to develop and implement emergency preparedness policies and procedures that included a system to address what action would be required due to the inability to make contact with staff or patients and reporting capabilities to the local and State emergency officials during an emergency. This had the potential to affect all 210 patients receiving home care services from the agency. The facility's Emergency Preparedness Plan included several policies required for emergency preparedness, however, lacked documentation to include procedures to follow-up with staff and patients and to inform state and local officials of any on-duty staff or patients that they are unable to contact during an emergency. During an interview on 4/28/22 at 9:30 a.m. the clinical manager stated the emergency plan did not include information regarding actions required when the agency was unable to make contact with staff or patients during an emergency and how this information would be reported to local and State officials, and that she would work on adding it the their plan.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on interview and policy review, the agency's communication plan failed to include all required information including names and contact information for the following: current staff, entities providing services under arrangement, and patients' physicians. This had the potential to affect all 210 patients receiving home care services from the agency. During review of the agency's undated Emergency Preparedness Plan, it was revealed the plan lacked to include employees, entities providing services under arrangement, and patients' physicians. On 4/28/22, at 9:36 a.m. the clinical manager (CM) confirmed the agency plan lacked the required information for names and contact information for staff, entities providing services under arrangement and patients' physicians. The CM stated she would be adding that information to their plan as required.

Information on Occupancy/Needs CFR(s): 484.102(c)(6) §403.748(c)(7), §416.54(c)(7), §418.113(c)(7) §441.184(c)(7), §482.15(c)(7), §460.84(c)(7), §483.73(c)(7), §483.475(c)(7), §484.102(c)(6), §485.68(c)(5), §485.68(c)(5), §485.727(c)(5), §485.625(c)(7), §485.920(c)(7), §491.12(c)(5), §494.62(c)(7). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (7) [(5) or (6)] A means of providing information about the [facility's] occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For ASCs at 416.54(c)]: (7) A means of providing information about the ASC's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For Inpatient Hospice at §418.113(c):] (7) A means of providing information about the hospice's inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This STANDARD is not met as evidenced by: Based on interview and policy review, the facility failed to ensure their communication plan included a means of providing information about the facility's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This had the potential to affect all 210 patients currently being served by the agency. During review of the Emergency Management Policies and disaster plan, the plan did not include a method for sharing information on the agency's or its ability to provide assistance. During interview on 4/28/22, at 9:00 a.m., the clinical manager confirmed there was nothing in the emergency plan that addressed sharing information on occupancy needs or ability to provide assistance to others in need.

A partial extended survey was conducted at your agency on 4/25/22, 4/26/22, 4/27/22 and 4/28/22. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. Unduplicated census: 210 (3 home visits completed). No branch offices. Hours of Operation: 8:00 a.m.- 4:30 p.m. Total number of records reviewed: 7

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview and document review, the agency failed to complete a comprehensive drug regimen review to ensure the accuracy of all medications/dosage for 1 of 3 patients (P4) whose medications were reviewed during home visit and record review. P4's plan of care (POC) 3/28/22 to 5/26/22, indicated a start of care (SOC) date of 3/28/22. P4's diagnoses included diverticulitis, disorder of white blood cells. atrial fibrillation, and hypertension. P4 was to receive skilled nurse visits (SNV) one to two visits per week for various assessments and educations, which were to include assessment of bowel sounds, lung sounds, vital signs, pain, and effectiveness of medications. Goals were to increase P4's knowledge and understanding of disease process and medications to promote compliance with medications. The nurse was to review and reconcile P4's medications at every visit. P4's POC included the following medications: aluminum-magnesium hydroxide (used for stomach upset) 30 milliliters (ml) every hour as needed (prn), apixaban (an anticoagulant medication to treat blood clots) 2.5 milligram (mg) twice a day (BID), atenolol (to treat high blood pressure) 50 mg daily, levofloxacin (an antibiotic) 750 mg every 48 hours, levothyroxine (to treat hypothyroid) 50 micrograms (mcg) daily, magnesium hydroxide (treat constipation) 30 ml daily prn, metronidazole (an antibiotic) 500 mg three times per day, sertraline (an antidepressant) 25 mg daily, simvastatin (to treat high cholesterol) 40 mg daily, and acetaminophen 650mg every four hours prn. During a home visit conducted on 4/26/22, at 10:30 a.m. P4's current medication bottles and medications setup in P4's medication boxes by her family for daily medication administration were compared to the medications listed on the POC, A current prescription bottle of amlodipine (to treat high blood pressure) 5 mg daily was observed among P4's medications and was setup daily in P4's medication administration boxes. P4 stated she took all the medications that were in the drawer and her family set them up weekly for her. Review of P4's hospital discharge orders dated 3/25/22, identified the medications on P4's POC were ordered daily and were to have included amlodipine 5 mg daily. When interviewed on 4/26/22, at 2:30 p.m. registered nurse (RN)-B stated P4's family set up her medications and did all the reordering of medications when needed. She asked P4 every visit if she had any medication changes and family was instructed to notify the agency if there were any changes with P4's medications. If the medication was not on the POC then the family must have told the agency P4 was not taking it. A verbal order would be done in that instance, so she was uncertain why there wasn't a verbal order to discontinue the amlodipine. She would have to review the chart. During interview on 4/27/22, at 10:30 a.m. clinical manager (CM) verified amlodipine was ordered 5 mg every day when P4 was discharged from the hospital on 3/25/22, and must have been missed during her medication review and so did not get listed on the POC. CM stated she had just called P4's family and was told P4 did take this medication daily and the medication had not been discontinued. She had sent P4's primary physician a fax to explain the medication was omitted on the agency's medication list and POC and would get that added now. The agency's policy Medication Profile with revision date 12/01/18, indicated a medication profile would be recorded of all of the client's prescribed and over the counter medications at the time of admission. The medication profile would be reviewed every sixty days and whenever there is a change or discontinuation of mediations. The agency's policy Medication Management dated 5/25/16, indicated the RN would maintain a current list of all prescribed and over the counter medications in the clinical chart. The nurse would complete a medication review at each visit to identify and review all of the medications the client is known to be taken.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on interview and document review, the agency failed to ensure visits were conducted in accordance with physician orders for 1 of 7 patients (P6) and failed to notify the physician when the visits were not conducted according to the plan of care (POC). P6's plan of care for certification period 3/10/21 to 5/8/21, indicated a start of care date 3/10/21. Diagnoses included diabetes mellitus, end stage renal disease, dependence on renal dialysis, and heart disease. Skilled nurse visit (SNV) were ordered one to two times per week for two months for various assessments and education. Home health aide (HHA) visits were ordered one to two times per week for two months to assist with bathing and activities of daily living (ADLs). Review of P6's medical record indicated P6 did not receive any HHA visits for the weeks of 4/25/21, 5/16/21, 5/23/21, 6/27/21 and 8/1/21, although HHA visits were ordered one to two times per week. The medical record lacked any documentation to indicate the physician was notified or consulted regarding the weeks of missed HHA visits. During interview on 4/28/21, at 10:30 a.m. the clinical manager verified there were no HHA services given to P6 for the weeks of 4/25/21, 5/16/21, 5/23/21, 6/27/21 and 8/1/21 and she could not find any documentation P6's primary physician had been notified of the agency's inability to provide services as ordered. CM stated it was the agency's practice to obtain verbal orders for all client missed visits. The agency typically ran a report weekly to track missed visits and for some reason this was not done for P6 and so the agency did not follow through and the primary physician was never updated. The agency policy Physician Orders dated 4/1/19, directed staff any deviation or change in frequency of personal care, home health aide, physical or occupational therapy or SNV require a physician order.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interview and document review the agency failed to obtain physician orders to provide increased skilled nursing visits (SNV) for 1 of 7 patients (P3) reviewed for home care services. P3's plan of care (POC) for certification period 1/20/22 to 3/20/22, indicated a start of care date of 10/11/06. Diagnoses included seizures, convulsions, anxiety, depression and other mental disorder. Skilled nurse visits (SNV) were ordered one time per week for two months for medication setup and various assessment and education. P3's POC for certification period 9/22/21 to 11/20/21 indicated SNVs were ordered one time per week for two months for various assessments, education and medication setup. P3's POC for certification period 5/25/21 to 7/23/21, indicated SNVs were ordered one time per week for two months for various assessments, education and medication setup. Review of P3's medical record revealed SNVs were completed two times per week on the weeks of 6/14/21, 7/4/21, 10/24/21 and 3/20/22. The medical record lacked documentation of physician notification or additional orders for the extra SNVs. During interview on 4/27/22, at 10:45 a.m. the clinical manager (CM) verified she was unable to find physician notification or physician orders for the extra SNV. The CM indicated it was the agency's practice to obtain verbal orders from the primary physician for any extra visits and the primary nurses were expected to obtain the verbal orders when they were needed. The agency policy Physician Orders dated 4/1/19, directed staff any deviation or change in frequency of personal care, home health aide, physical or occupational therapy or SNV require a physician order.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on interview and document review the agency failed to implement an infection control program that included tracking, trending and analysis of client and staff infections. During interview on 4/27/22, at 10:45 a.m. the clinical manager (CM) stated she acted as the agency's Infection Control nurse and the agency did not have an infection control program for tracking, trending and analysis of client or staff infections. There was no policy on how they would identify infections among patients. There was no plan based on surveillance findings, or how they would identify root cause of infections or disease transmission. The CM indicated she was not aware of the requirement and did not have a policy. She would work on getting a program implemented. The agency's undated policy Care Of The immune Suppressed and At Risk Client indicated home acquired infections shall be reported to the Infection Control nurse for trends, analysis, recommendations and follow up.

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 interview and document review the agency failed to ensure those staff who were not fully vaccinated or who had been granted an exemption adhere to additional precautions intended to mitigate the spread of COVID-19. During a home visit conducted on 4/26/22, at 10:30 a.m. home health aide (HHA)-A was observed providing personal care assistance to patients of the agency. HHA-A wore two surgical masks and gloved when performing direct cares. During interview on 4/26/22, at 11:00 a.m. HHA-A indicated she was not vaccinated for COVID-19 and had been granted an exemption from the agency from the COVID-19 vaccination requirements. She was required to wear two surgical masks when providing client cares and interacting with clients. HHA-A stated she had never been tested for CIVID-19 and was not aware of any requirement of having to do so. Review of the agency's Call In of COVID-19 Tests-weekly before first scheduled client of the week revealed HHA had been called on 4/4/22, 4/11/22, 4/18/22, and 4/25/22, and had reported no symptoms of COVID-19 as well as not having tested for COVID-19 each week as required. Each week it was documented she was reminded to come into the office to test. When interviewed on 4/27/22, at 10:45 a.m. the clinical manager (CM) stated the agency called each unvaccinated staff at the start of the week and asked if they had experienced any symptoms of COVID-19 and the results of their COVID-19 at home test. She was not aware HHA-A had not been testing and would bring her in before her next scheduled shift to test. She would also educate the office staff to notify her immediately if an employee was refusing weekly testing. Review of agency COVID -19 vaccination logs and policy indicated the agency had 10 employees who had been granted exemptions from the COVID-19 vaccination requirements. Review of the agency's undated policy Post Exposure Evaluation and Follow Up For COVID-19 indicated the exempt staff were required to test weekly for COVID-19 and report results to the agency and wear an approved N95 mask or equivalent mask with providing client cares and interacting with clients.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on observation, interview and record review the home health agency (HHA) failed to provide an ongoing interdisciplinary assessment of a patient during a skilled nurse visit for 1 of 2 patients (P3) observed for skilled nurse visits in the home. P3's plan of care (POC) dated 3/21/22 to 5/19/22, indicated a start of care (SOC) date 10/11/06. P3 had diagnoses of seizures, unspecified convulsions, anxiety disorder, depression and other mental disorder. P3 was to receive skilled nurse visits (SNV) one time per week for two months for overall assessment and medication setup. Ongoing goals for P3 were listed; to increase his knowledge of disease processes to client and for P3's vital signs to be within normal limits. P3 to verbalize symptoms of seizure activity, when, why and how to report changes. P3 to be compliant with medication regimen and understand use/benefits and effects. P3 to remain safe in home and adequate airway clearance during seizures. P3 was observed on 4/26/22, at 9:00 a.m. during a home SNV. Registered nurse (RN)-A was observed to wash her hands, greet P3 and then completed P3's medication setup. RN-A questioned P3 briefly regarding if he had any changes or concerns related to his gastrointestinal status or if he had experienced any problems or falls since the last SNV. RN-A was not observed to perform any type of physical assessment, auscultation of lung or heart sounds or to obtain P3's blood pressure, pulse or respirations. ON 4/26/22, at 9:35 a.m. RN-A stated she never checked P3's vital signs as he had weekly physician appointments and his vital signs were obtained at these appointments. Although the agency's goal was to prevent emergency room visits and hospitalizations, she did not feel P3 needed further assessment during his SNV as he had an active case manager at the clinic, frequent psychiatric appointments and weekly physician visits. Review of documentation of skilled nurse visits identified blood pressure measurements, pulse rate and quality and respirations, which were recorded on each skilled nurse visit reviewed, including the 4/26/22, SNV. When interviewed on 4/27/22, at 10:45 a.m. the agency's clinical manager (CM) stated the nurse did not check P3's vital signs because he was seen one time per week by his physician. The agency's goal was to keep P3 out of the emergency room and hospital as he utilized the emergency room frequently for stomach issues. The CM confirmed a physical assessment during SNV and vital signs would be an important intervention toward this goal. The CM stated the vital signs and cardiac and lung assessment recorded weekly in the SNV was data the nurse had obtained from his physician weekly visit notes and were not obtained by the nurse herself. The CM verified there was no documentation in the charting to indicate the assessment data was not obtained at the time of the SNV and the charting did not reflect what actually occurred during the visit. The CM verified an overall patient assessment, including vital signs and heart and lung assessment was expected during every skilled nursing visit. A facility policy for skilled nurse assessments was requested, however was not received.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on interview and document review the agency failed to ensure ongoing interdisciplinary assessment of the patient included patient and caregiver education when a patient (P6) was newly diagnosed with Clostridium Difficile (c.difficile) (an infection of the colon that can be transmitted from person to person by touching contaminated surfaces) and who had received home health aide visits to assist with activities of daily living (ADLs) including bathing. P6's POC for certification period 9/6/21 to 11/4/21, indicated at start of care date 3/10/21. Diagnoses included diabetes mellitus, end stage renal disease, dependence of renal dialysis and heart disease. Skilled nurse visits (SNV) were ordered one to two times per month for two months for various assessments and education and HHA one to two visits per week for two months to assist with bathing and ADLs. A Revision To Plan Of Care dated 9/13/21, reviewed P6's new diagnosis of c. diff. with his primary physician and verbal order for vancomycin (an antibiotic). On 9/13/21, a SNV was documented and identified a new diagnosis and treatment for c.difficile. HHA supervision was completed. The medical record lacked HHA and patient education related to the new diagnoses or need for additional infection control precautions to prevent spread of the disease to others. On 10/15/21, a SNV was documented and identified ongoing symptoms of c.difficile. HHA supervision was performed. The medical record lacked HHA and patient education related to the need for additional infection control precautions related to the diagnosis and symptoms of c. difficile to prevent spread of the disease to others. Weekly Assignment sheets for HHA Hour indicated P6 had HHA visits to assist for bath, skin care, cleaning of equipment on 9/13/21, 9/20/21,9/22/21, 9/27/21, and 9/29/21. The documentation lacked identification of increase infection control precautions related to c. difficile. Review of P6's HHA plan of care dated 3/10/21, lacked identification of the diagnosis of c.diff or any HHA instruction for additional precautions to prevent the spread of the disease. During interview on 4/28/22, at 10:30 a.m. the clinical manager (CM) stated she was unable to find any education of the agency staff for c. difficile and indicated she would expect the nurse to provide guidance and instruction to both the client and the home health aides when a client had a diagnosis of c.difficile to help to prevent further spread of the disease. There should have been some documentation that education was done and the agency planned to educate their staff regarding when further instruction, guidance and education was needed. A policy for infection control was requested, however, none was provided.