Every finding on record at Clarkfield Home Health Agency

On 6/26/23 through 6/28/23, a survey for compliance with Appendix Z, Emergency Preparedness Requirements for Long Term Care facilities was conducted during a standard recertification survey. The facility was NOT in compliance. The facility's plan of correction (POC) will serve as you allegation of compliance upon the Department's acceptance. Because you are enrolled in ePOC, your signature is not required at the bottom of the first page of the CMS-2567 form. Upon receipt of an acceptable electronic POC, an onsite revisit of your facility may be conducted to validate substantial compliance with the regulation has been attained.

EP Program Patient Population CFR(s): 484.102(a)(3) §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.542(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.** *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do all of the following: (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. *NOTE: ["Persons at risk" does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.] This STANDARD is not met as evidenced by: Based on interview and document review, the facility failed to develop a comprehensive assessment of the patients served by Clarkfield Home Health Agency (HHA) to include at-risk populations. This had the potential to affect all patients who were provided service by the agency. An agency policy, titled Emergency Procedure/911 Calls, last reviewed and revised July 2019, was provided to surveyor to review. The policy lacked an assessment or identification of the population served which was to include at-risk populations who had the potential to require additional response assistance, including those who have disabilities, are living in institutionalized settings, are from diverse cultures, racial and ethnic backgrounds, have limited English proficiency or are non-English speaking, lack transportation, have chronic medical disorders, or have pharmacological dependency. On 6/27/23, at 3:30 p.m. the HHA Director stated she did not have additional documentation to reflect a compilation of this information for at-risk populations who are served by the HHA.

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on interview and document review the agency failed to complete testing for emergency preparedness within the past three years. This had the potential to impact all patients served by the agency. An agency policy, titled Emergency Procedure/911 Calls, last reviewed and revised July 2019, was provided to surveyor to review. A review of the documentation and information lacked any indication of past testing and training of the Emergency Preparedness policies and processes identified as a potential risk based on the Hazard Vulnerability Assessment. The policy lacked the required elements for testing identified as follows: Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility]must do all the following: (i) Participate in a full-scale exercise that is community-based every two years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every two years; or (B) if the [facility] experienced an actual 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 two years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, which 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 group discussion using a narrated, clinically relevant scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge and emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercise, and emergency events, and revise the [facility's] emergency plan, as needed. During interview on 6/27/23, at 3:30 p.m. the HHA Director stated the agency had not completed an exercise during the past three years. Documentation was provided from the Health Care Coalition in the form of an After-Action Report from an exercise held on 6/14/22 related to communication processes through MNTRAC (a state-wide computer-based format), and with use of ARMER radios. The Director stated they did not participate in this exercise, and the mode of communication tested were not used within in their agency. Although the facility had responded to the Covid pandemic, the facility lacked documentation in the form of an after-action report and improvement plan.

On 6/26/23-6/28/23 a recertification and complaint survey was conducted. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. H71523063C and H71523064C, no deficiencies were issued. 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: 4 Total home visits conducted: 0. There were no skilled services provided at the time of the recertification. The home health survey was completed at Clarkfield Home Health Agency at 1012 12th Avenue, Clarkfield, MN 56223. There are no branch offices for this agency. List Hours of Operation: 8:00 a.m. to 4:30 p.m. List total number of records reviewed: 5

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 interview and document review the agency failed to maintain current certification for the Clinical Laboratory Improvement Amendments (CLIA) waiver, which is required for agencies performing blood testing. This had the potential to affect all patients care for by the agency. On 6/27/23, at 3:30 p.m. it was noted the posted Clinical Laboratory Improvement Amendments (CLIA) waiver was noted to have an expiration of 4/3/23. On 6/27/23, at 3:30 p.m. the Director stated she was unaware the CLIA certificate had expired and had not received the renewal notifications from the Centers for Medicare and Medicaid Services (CMS). Upon further investigation, the Director informed the surveyor the renewal information had been sent to the physical address which had been listed on the certificate, and where the agency had previously resided. The agency had subsequently moved and the address had not been changed.