Every finding on record at Care Plus Home Health Agency Inc

A survey for compliance with CMS Appendix Z Emergency Preparedness Requirements, was conducted on 4/21/25 to 4/23/25 during a recertification survey. The facility is in compliance with the Appendix Z Emergency Preparedness Requirements.

On 4-21-25 to 4-23-25 a recertification survey was conducted. This resulted in a partial extended survey at Care Plus Home Health Agency. 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: 99 Total home visits conducted: 3 List Parent Location visit. Care Plus Home Health Agency 1299 Arcade Street, Suite 100 St. Paul, MN 55106 List Hours of Operation: 8 AM-4:30 PM List total number of records reviewed: 7

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 documentation and interview, the facility failed to report all OASIS data collected in accordance with federal regulations. Total number of records submitted beyond the 30 days was three hundred and sixty, which equaled 27.84% of the submissions submitted. Findings include: On the HHA Error Summary by Agency report period of 3/1/24 to 3/14/25, the agency had an error code of -3330: record submitted late. The description included the submission was more than 30 days after completion on the new record. During an interview on 4/22/25 at 1:00 p.m., the director of nursing (DON) stated the agency's normal OASIS assessment process was to have the licensed nurse complete in the patient's electronic medical record and then office staff would transmit. The DON confirmed the agency staff had problems completing and submitting OASIS assessments on time related to various reasons including patient visit scheduling issues due to refusals, hospitalizations or need of an interpreter. The agency policy Encoding and reporting OASIS Data dated 2/3/25, identified the facility will electronically report all OASIS data collected in accordance with federal regulations including encoding individual client assessment within thirty days of completing the assessment and transmitted within thirty days of the Oasis completion.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on observation, interview and document review, the agency failed to ensure a registered nurse (RN) conducted an initial assessment to determine the immediate care, and support needs forty-eight hours from the initial referral date for 2 of 7 (P1, P6) patients reviewed for appropriate and timely start of care. Findings include: P1's electronic medical record (EMR) and plan of care (POC) with certification dates of 3/31/25 to 5/29/25 identified a referral date of 1/10/25 and an admit date of 1/30/25. P1's EMR lacked documentation as to why the initial admit wasn't completed within forty-eight hours of referral and with no notification to the provider. P6's EMR and POC with certification dates of 1/8/25 to 3/8/25 identified a referral date of 9/4/24 and an admit date of 9/10/24. P6's EMR lacked evidence of provider notification and documentation as to why the initial admit wasn't completed within forty-eight hours of referral. When interviewed on 4/22/25 at 1:00 p.m., the director of nursing stated the agency process is to have a patient admitted and comprehensive assessment completed within forty-eight hours of referral to ensure client safety and care needs. The DON confirmed a patient's provider should be notified if the agency was unable to admit and complete and complete an initial assessment within 48 hours. The DON stated this was difficult at times related to referrals with incomplete patient information coming from county agencies and not being able to schedule the initial assessment with the patient themselves. The agency policy Comprehensive Client Assessment dated 2/3/25, identified the initial assessment visit must be held either within 48 hours of referral or within forty-eight hours of the client's return home, or on the physician ordered start of care date to determine the appropriate care, treatment and services to meet client initial needs and his/her changing needs.

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 observation, interview and document review, the agency failed to ensure medications were set up only as ordered by a physician or allowed practitioner for 1 of 2 patients (P4) observed during a skilled nursing home visit. Findings include: P4's plan of care (POC) with a certification date of 3/2/25 to 4/30/25, with a start of care (SOC) date of 3/18/22, identified the diagnoses of chronic obstructive pulmonary disease (COPD), Sjogren syndrome (an immune system illness), depression and anxiety, received skilled licensed nurse visits one time per week for medication management and set up and had medication orders for methotrexate (a medication used for inflammation) 2.5 milligrams (mg) four tablets every Monday and methotrexate 2.5 mg four tablets every Wednesday. During observation on 4/21/25 at 12:45 p.m., licensed practical nurse (LPN)-A added four tablets of methotrexate 2.5 mg into P4's Wednesday section of her pill box. LPA also added the over-the-counter supplement Magnesium 400 mg each day in the med box which was not listed on P4's medication orders. After completion of the medication box set-up, LPN-A was asked why P4's medication box was set-up without the second doses of her methotrexate order and the additional magnesium with no order and stated P4 had only been taking one dose of her methotrexate and the magnesium per her preference. LPN-A acknowledged the normal agency process when managing a patient's medication was to check the orders with the medications and ensure they matched and if not, she would need to communicate with the patient's provider to clarify. LPN-A confirmed P4 had been taking only one dose of methotrexate and magnesium "for a while" and she had not updated the provider. When interviewed on 4/21/25 at 1:00 p.m., P4 stated she had stopped taking her Monday dose of methotrexate about 'three to four months ago" and recently bought the magnesium supplement to help with constipation and had asked LPN-A to fill her med box this way. P4 denied any ill effects from taking her medications this way but agreed her provider and med list should be updated. When interviewed on 4/21/25 at 2:17 p.m., the director of nursing (DON) confirmed standard agency practice was to check the patient medication orders with the patient's home medications to ensure accuracy with each visit and if there was a discrepancy the patient's provider should be updated immediately. The facility policy Medication Set Up dated 2/3/25, identified the patient plan of care is the nurse's responsibility to ensure that it is accurate and without errors, the medications are reviewed at each visit to determine if there are new or changed orders including over the counter medications.

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 ensure their Clinical Laboratory Improvement Amendment Certificate (CLIA) was current. Findings include: During document review on 4/21/25 at 10:00 a.m, it was noted the agency CLIA waiver had expired on 3/2/25. During interview on 4/21/25 at 10:15 a.m., the administrator stated he had inadvertently missed renewing the agency CLIA waiver and then immediately initiated the renewal online.

On 2/27/23 through 3/2/23, 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 your 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.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (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 all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [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. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on interview and document review, the facility failed to develop a process to review and update the emergency preparedness plan on a biannual basis. This had the potential to affect all patients who receive services from the agency. A facility document, titled Emergency Preparedness and Policy Process, identified a review/revise date of 1/1/2018. When interviewed on 3/1/23, at 2:15 p.m. the administrator stated he was unaware the agency Emergency Preparedness Plan must be reviewed at least every two years, with updates made as indicated. The administrator verified there was no further review or documentation of this policy since the date identified on the policy.

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 Care Plus 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 Preparedness and Policy Process, which indicated this was last revised on 1/1/2028 was provided to surveyor for review. The policy lacked an assessment or identification of the population served which included at-risk populations, who had the potential to require additional response assistance including those who have disabilities, live in institutionalized settings, are from diverse cultures and racial and ethnic backgrounds, have limited English proficiency or are non-English speaking, lack transportation, have chronic medical disorders, or have pharmacological dependency. On 3/1/23, at 2:15 p.m. the administrator stated he was unaware the agency Emergency Preparedness Plan was to contain an assessment to include the patient population served and identify the at-risk populations and verified their policy did not contain the required information.

Policies/Procedures for Medical Documentation CFR(s): 484.102(b)(4) §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(b) Policies and procedures. The [facilities] 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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This STANDARD is not met as evidenced by: Based on document review and interview, the agency failed to develop a policy for medical documentation for emergency preparedness response. This had the potential to affect all 126 patients served by the agency. A facility document, titled Emergency Preparedness and Policy Process, identified a review/revise date of 1/1/2018 was provided for review. When interviewed on 3/123, at 2:15 p.m. the administrator stated the policy, titled Emergency Preparedness and Policy Process, last revised on 1/1/2028, included all of the facility policies for emergency preparedness. The administrator was unaware of the requirement of the requirement to develop a system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records during an emergency response. The administrator verified there was no additional documentation or policies/procedures for documentation during emergency response.

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.542(b)(6), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [facilities] 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 [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on interview and document review, the facility failed to include volunteer and staffing guidelines with the Emergency Preparedness plan for the agency. This had the potential to affect all patients served by the agency. A policy, titled Emergency Preparedness and Policy Process, last revised on 1/1/2028, was provided for review and was noted to lack inclusion of the role of volunteer in an emergency response. During interview on 3/1/23, at 2:15 p.m., the administrator stated he was unaware of the requirement to identify the potential agency use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. The administrator verified there was no further review or documentation of this policy since the date identified on the policy.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) §403.748(c)(2), §416.54(c)(2), §418.113(c)(2), §441.184(c)(2), §460.84(c)(2), §482.15(c)(2), §483.73(c)(2), §483.475(c)(2), §484.102(c)(2), §485.68(c)(2), §485.542(c)(2), §485.625(c)(2), §485.727(c)(2), §485.920(c)(2), §486.360(c)(2), §491.12(c)(2), §494.62(c)(2). [(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: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on observation and interview, the facility failed to provide contact information for the local emergency officials within the facility plans for emergency preparedness plans. This had the potential to impact all 126 patients. A policy, titled Emergency Preparedness and Policy Process, which indicated this was last revised on 1/1/2028 was provided to surveyor for review. The policy lacked information as to contact information for emergency individuals. The administrator verified there was no further documentation or information with the contact information since the date identified on the policy. On 3/1/23, at 2:15 p.m. The administrator he was unaware of the need to include the contact information for the emergency officials within the agency policy for emergency preparedness, to include Federal, State, tribal, regional, and local emergency preparedness staff and other sources of assistance.

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 interview and document review the agency to complete testing for emergency preparedness since 4/26/2019. This had the potential to impact all patients served by the agency. On 3/1/23, at 2:15 p.m. the facility's Emergency Preparedness and Policy Process, last reviewed 1/1/18, was provided to surveyor for review. The documentation identified the last exercise was completed on 4/26/2019. 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 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. During interview on 3/1/23, at 2:15 p.m., the administer stated although the agency continued with provision of services during the pandemic, they had not reviewed the process formally or completed any documentation to reflect response to the pandemic, development of an after-action report, or development of an improvement plan. The administrator stated there was no additonal information to be reviewed.

On 2/27/23-3/2/23 a recertification survey was conducted. This resulted in a partial extended survey at Care Plus Home Health Agency (HHA). 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: 126 Total home visits conducted: 3 The home health survey was completed at Care Plus HHA located at 1299 Arcade Street, suite 100, St Paul, MN. 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: 7

Treatment or care CFR(s): 484.50(e)(1)(i)(A) (i)(A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; and This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to thoroughly investigate a complaint voiced by 1 of 1 patient (P3) who had voiced a complaint of improper medication set up. P3's Admission Profile, identified P3 had the diagnoses of chronic congestive heart failure, mild, intermittent asthma (a disease which causes increased difficulty breathing), and essential hypertension (high blood pressure). P3's plan of care (POC) for certification period of 1/5/23-3/5/23, indicated P3 was to receive skilled nursing visits on a weekly basis. The POC indicated P3's services were to include medication management, completing INRs (a blood test used for determining how blood clots for dosing of Coumadin (warfarin-blood thinner), and monitoring GU (genitourinary symptoms), pain status, neuro (neurological) and mental status. On 2/28/23, at 8:30 a.m. P3 was texting with family member (FM)-A regarding home visit made. P3 stated FM-A thought perhaps the visit was being made in follow up regarding the medication mix up which had happened approximately four to six weeks ago. P3 stated she had restless legs syndrome and took medications to manage this. P3 stated approximately four to six weeks ago she was experiencing extreme leg pain, like something she could not even explain and had not had before. P3 stated she went to bed in attempt to seek relief from the pain. P3 stated she prayed for answers, and it came to her to check her meds. P3 stated she and her husband looked through the med set and saw there was a blue pill in the bedtime dose of medications. The following morning, P3's husband took the medications into the pharmacy for identification. At that time, the medication was identified as Tolterodine (a medication used for bladder spasm). P3 stated the medication was placed in the med set in place of Ropinirole (a medication used for treatment of moderate-to-severe restless legs syndrome). P3 stated the medications were corrected in the med set and the pain resolved almost immediately, without further problem. P3 stated the error concerned her as there was the potential for this to occur again. On 2/28/23, at 3:30 p.m. the director of nursing (DON) stated she was aware of the medication error for P3. DON stated she was unsure if both doses of the ropinirole were missed. P3 was to receive a both a 0.5 mg dose and a 2 mg tablet of ropinirole. DON stated she had made a home visit and the medications were already switched out. DON stated there were no further problems after that. DON stated the medication set up had been completed by licensed practical nurse (LPN)-A. DON stated following the home visit, she had completed a medication error form and sent this to the primary doctor for review. DON stated she had not heard back in follow up from the provider and was unsure if the provider had contacted P3. DON did not follow up with the provider. DON stated she had followed up with LPN-A regarding the error and stated LPN-A was unsure how the med error occurred. Although DON had followed up with LPN-A, there was no further documentation as to the complaint/med error investigation or identified steps to prevent this from recurring in the future. On 2/28/23, at 4:00 p.m. during a follow up interview with the administrator and DON, both stated at this time there was tracking system in place for complaints, as they had no recent complaints since 5/7/18. Upon request for a policy or procedure for complaint investigation and follow up, both administrator and DON stated there was no policy in place.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to ensure each patient had an initial assessment within 48 hours of their referral date for 3 of 7 patients (P1, P3 and P7) reviewed who received nursing services. P1's Admission Profile, indicated P1 had diagnoses of chronic obstructive pulmonary disease (COPD), depression and Sjogren syndrome. P1's start of care, outcome and assessment information set (Oasis) assessment for certification period of 3/18/22 to 5/16/22, was dated 3/18/22 and indicated a referral date of 3/14/22. The clinical record failed to identify a reason why P1 had not been assessed within 48 hours of the initial referral date of 3/14/22. P1's plan of care for certification period of 3/18/22 to 5/16/22, identified a start of care date of 3/18/22. POC indicated R1 would receive weekly nursing services for medication management and compliance. P7's Admission Profile, indicated P7 had diagnoses of paralytic syndrome, alcoholic cirrhosis of the liver with ascites and chronic obstructive pyelonephritis. P7's start of care, outcome and assessment information set (Oasis) assessment for certification period of 5/2/22 to 6/30/22, was dated 5/2/22 and indicated a referral date of 4/29/22. The clinical record failed to identify a reason why P7 had not been assessed within 48 hours of the initial referral date of 4/29/22. P7's plan of care for certification period of 5/2/22 to 6/30/22, identified a start of care date of 5/2/22. POC indicated R7 would receive weekly nursing services for medication management and compliance. During an interview on 3/2/23, at 1:34 p.m. director of nursing (DON) stated an unawareness of why the assessments were not completed timely and was not sure why the physician had not been notified of the delay in care. Facility policy requested and was not available.

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 ensure medication regimen reviews were completed to ensure medications identified on the plan of care (POC) were available and set up as ordered by physician for 2 of 3 patients (P3 and P4) seen with in home visits. P4’s Admission Profile, identified P4 had the diagnoses of bipolar disorder (disease that causes extreme mood swings that include emotional highs (mania or hypomania) and lows (depression) and hypertension (high blood pressure). P4’s plan of care (POC) for certification period of 1/21/23-3/21/23, identified a start of care of 4/12/19. POC indicated P4 was to receive skilled nursing visits on a weekly basis and indicated services were to include medication management and assistance with Libre sensor (a diabetic glucometer that measures glucose levels through a small sensor that is applied to the back of your upper arm. It provides real-time glucose readings for up to 10 days, both day and night). Further indicated the following medication orders: Metformin (antidiabetic medication) extended release (ER) 1000 mg to be given daily, Oxybutynin (bladder relaxant) ER 10 mg to be given daily and cyclobenzaprine (muscle relaxant) 10 mg to be given as needed for muscle spasms up to three times a day. During an observation on 2/28/23, at 10:43 a.m. the Medication Profile on the POC was reviewed with P4, with a comparison made to medications on hand. P4 had the following medications present which she stated she used consistently with the exception of her muscle relaxant which she took on an as needed basis. Metformin 1000 mg tablet, Oxybutynin 15 mg tablet, and cyclobenzaprine 5 mg tablet. During an interview on 2/28/23, registered nurse (RN)-A was noted to set up P4’s medications in her weekly pill minder. RN-A verified P4’s POC did not match the way she set up P4’s medications. P4’s metformin was not extended release, RN-A stated she was setting up 1000 mg twice a day per P4’s prescription bottle and not 1000 mg daily as the POC directed. P4’s Oxybutynin was not extended release and was set up to give 15 mg versus the 10 mg as indicated on the POC. RN-A stated P4’s cyclobenzaprine that was on hand was 5mg and the POC indicated she was to receive 10 mg. During an interview on 3/1/23, at 4:04 p.m. the director of nursing (DON) stated, medication review and reconciliation was to be completed with every medication set up and was to be amended on the POC when changes were identified. A policy was requested for medication set up and medication reconciliation process but was not received. P3's Admission Profile, identified P3 had the diagnoses of chronic congestive heart failure, mild, intermittent asthma (a disease which causes increased difficulty breathing), and essential hypertension (high blood pressure). P3's plan of care for certification period of 1/5/23-3/5/23, identified a start of care of 7/14/21. POC indicated P3 was to receive skilled nursing visits on a weekly basis and indicated services were to include medication management and completing INRs (a blood test used for determining how blood clots for dosing of Coumadin (warfarin-blood thinner). On 2/28/23, at 8:30 a.m. the Medication Profile was reviewed with P3, with a comparison made to medications on hand. P3 identified the following medications were no longer used, although listed on the POC Medication Profile: Terazol 7 Vaginal cream, Simethicone 80 mg chewable tablets, Allopurinol Oral tablet, CBD Oil phylocannabnoid 5 mg rich hemp, melatonin gummies, Naloxone HCl Nasal Liquid (a medication used for potential narcotic overdose). In addition to the above listed medication no longer being used, P3 had the following medications present which she stated she used consistently: Warfarin (both 5 mg and 2.5 mg with doses based on INR results), Crestor (cholesterol lowering medication) taken daily, Hydrocodone/Acetaminophen 5 mg/325 mg as needed for pain, Icy Hot topical roll-on and Asper Creme/Lidocaine roll-on as needed for pain management. P3 stated the staff had not routinely completed medication review and reconciliation with medication set up and recertification visits. On 2/28/23, at 3:30 p.m. the director of nursing (DON) stated medication review and reconciliation was to be completed with every medication set up and was to be amended on the POC when changes were identified. DON stated she had completed the recertification and must have missed this.

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 observation, interview and document, the agency failed to revise and update patient medication profile on the plan of care to accurately reflect medication changes in the past certification period for two of three patients (P3, P4) observed with home visits and medication review. P4’s Admission Profile, identified P4 had the diagnoses of bipolar disorder (disease that causes extreme mood swings that include emotional highs (mania or hypomania) and lows (depression) and hypertension (high blood pressure). P4’s plan of care (POC) for certification period of 1/21/23-3/21/23, identified a start of care of 4/12/19. POC indicated P4 was to receive skilled nursing visits on a weekly basis and indicated services were to include medication management and assistance with Libre sensor (a diabetic glucometer that measures glucose levels through a small sensor that is applied to the back of your upper arm. It provides real-time glucose readings for up to 10 days, both day and night). Further indicated the following medication orders: Metformin (antidiabetic medication) extended release (ER) 1000 mg to be given daily, Oxybutynin (bladder relaxant) ER 10 mg to be given daily and cyclobenzaprine (muscle relaxant) 10 mg to be given as needed for muscle spasms up to three times a day. During an observation on 2/28/23, at 10:43 a.m. the Medication Profile on the POC was reviewed with P4, with a comparison made to medications on hand. P4 had the following medications present which she stated she used consistently with the exception of her muscle relaxant which she took on an as needed basis. Metformin 1000 mg tablet, Oxybutynin 15 mg tablet, and cyclobenzaprine 5 mg tablet.. During an interview on 2/28/23, registered nurse (RN)-A was noted to set up P4’s medications in her weekly pill minder. RN-A verified P4’s POC did not match the way she set up P4’s medications. P4’s metformin was not extended release, RN-A stated she was setting up 1000 mg twice a day per P4’s prescription bottle and not 1000 mg daily as the POC directed. P4’s Oxybutynin was not extended release and was set up to give 15 mg versus the 10 mg as indicated on the POC. RN-A stated P4’s cyclobenzaprine that was on hand was 5mg and the POC indicated she was to receive 10 mg. During an interview on 3/1/23, at 4:04 p.m. the director of nursing (DON) stated, medication review and reconciliation was to be completed with every medication set up and was to be amended on the POC when changes were identified. P3's Admission Profile, identified P3 had the diagnoses of chronic congestive heart failure, mild, intermittent asthma (a disease which causes increased difficulty breathing), and essential hypertension (high blood pressure). P3's plan of care for certification period of 1/5/23-3/5/23, identified a start of care of 7/14/21. POC indicated P3 was to receive skilled nursing visits on a weekly basis and indicated services were to include medication management and completing INRs (a blood test used for determining how blood clots for dosing of Coumadin (warfarin-blood thinner). On 2/28/23, at 8:30 a.m. the Medication Profile on POC was reviewed with P3, with a comparison made to medications on hand. P3 had the following medications present which she stated she used consistently: Warfarin (both 5 mg and 2.5 mg with doses based on INR results), Crestor (cholesterol lowering medication) taken daily, Hydrocodone/Acetaminophen 5 mg/325 mg as needed for pain, Icy Hot topical roll-on and Asper Creme/Lidocaine roll-on as needed for pain management. P3 stated Crestor was started in December (2022) and identified she had been on Warfarin and Hydrocodone/Acetaminophen long term. P3 stated she took the appropriate dose of Warfarin as the doses would be adjusted based on blood work. In addition to the medications not listed, P3 identified the following medications were no longer used, but continued to be listed on the medication profile: Terazol 7 Vaginal cream, Simethicone 80 mg chewable tablets, Allopurinol Oral tablet, CBD Oil phylocannabnoid 5 mg rich hemp, and melatonin gummies. P3's medication listing in the medication bin identified P3 was on Crestor, however, this was not on the plan of care medication profile. P3 stated the staff had not routinely completed medication review and reconciliation with medication set up and recertification visits. On 2/28/23, at 3:30 p.m. the director of nursing (DON) stated medication review and reconciliation was to be completed with every medication set up and was to be amended on the POC when changes were identified. DON stated she had completed the recertification and must have missed this. A policy was requested for medication set up and medication reconciliation process but was not received.

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 follow physician orders for pressure ulcer wound treatments for 1 of 7 patients (P7), reviewed in the sample. P7's Admission Profile, indicated P7 had diagnoses of paralytic syndrome, alcoholic cirrhosis of the liver with ascites (accumulation of fluid in the abdomen) and chronic obstructive pyelonephritis (kidney obstruction). P7's plan of care (POC) for certification period of 5/2/22 to 6/30/22, identified a start of care date of 5/2/22. POC indicated R7 would receive weekly nursing services for medication management and compliance. P7's physician verbal order, dated 6/30/22, identified to increase skilled nursing visits to two times a week; cleanse left gluteal cleft and apply hydrocolloid dressing two times weekly and PRN [as needed] if soiled. P7's medical record identified that P7 received skilled nursing visits on 6/29/22, 7/6/22, on 7/13/22. P7's medical record lacked documentation that skilled nursing visits to provide wound care were performed twice weekly through this time period, where P7 missed two physician ordered dressing changes for a pressure ulcer to the buttocks. Further lacked documentation of notification to provider that the order was not followed. During an interview on 3/2/23, at 1:34 p.m. director of nursing (DON) stated an unawareness of why the physician ordered dressing changes were not performed, and stated the physician should have been notified. Facility policy for physician orders was requested and was not available.

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: Based on observation, interview and document review, the agency failed to promptly alert relevant physician of a change in medication doses for 1 of 3 patients (P4) observed during a home visit with medication review and for 1 of 3 patients (P6) when the agency failed to ensure a physician was notified when ordered glucometer was available to monitor blood sugars, and failed to notify physician when blood sugars were out of range . P4’s Admission Profile, identified P4 had the diagnoses of bipolar disorder (disease that causes extreme mood swings that include emotional highs (mania or hypomania) and lows (depression) and hypertension (high blood pressure). P4’s plan of care (POC) for certification period of 1/21/23-3/21/23, identified a start of care of 4/12/19. POC indicated P4 was to receive skilled nursing visits on a weekly basis and indicated services were to include medication management and assistance with Libre sensor (a diabetic glucometer that measures glucose levels through a small sensor that is applied to the back of your upper arm. It provides real-time glucose readings for up to 10 days, both day and night). Further indicated the following medication orders: Metformin (antidiabetic medication) extended release (ER) 1000 mg to be given daily, Oxybutynin (bladder relaxant) ER 10 mg to be given daily and cyclobenzaprine (muscle relaxant) 10 mg to be given as needed for muscle spasms up to three times a day. During an observation on 2/28/23, at 10:43 a.m. the Medication Profile on the POC was reviewed with P4, with a comparison made to medications on hand. P4 had the following medications present which she stated she used consistently with the exception of her muscle relaxant which she took on an as needed basis. Metformin 1000 mg tablet, Oxybutynin 15 mg tablet, and cyclobenzaprine 5 mg tablet. During an interview on 2/28/23, registered nurse (RN)-A was noted to set up P4’s medications in her weekly pill minder. RN-A verified P4’s POC did not match the way she set up P4’s medications. P4’s metformin was not extended release, RN-A stated she was setting up 1000 mg twice a day per P4’s prescription bottle and not 1000 mg daily as the POC directed. P4’s Oxybutynin was not extended release and was set up to give 15 mg versus the 10 mg as indicated on the POC. RN-A stated P4’s cyclobenzaprine that was on hand was 5mg and the POC indicated she was to receive 10 mg. RN-A stated the physician should be notified, stated she would do it after she was done with her patient visits for the day. During an interview on 3/1/23, at 4:04 p.m. the director of nursing (DON) stated, medication review and reconciliation was to be completed with every medication set up and was to be amended on the POC when changes were identified. DON stated P4’s physician should have been notified immediately to ensure P4 was receiving the correct dose of medications. I will have to educate RN-A on that. P6’s Admission Profile, identified P6 had the diagnoses of Parkinson’s disease (a brain disorder that causes unintended or uncontrollable movements, such as shaking, stiffness, and difficulty with balance and coordination), and Type 2 diabetes mellitus with hyperglycemia (elevated blood sugar) and without complications. P6’s after visit summary (AVS) dated 3/31/22, indicated P6 was hospitalized from 3/28/22 to 3/31/22, indicated P6 presented with blood sugars in the 600’s (extremely high) and was admitted to the intensive care unit (ICU) on a low dose insulin drip. Upon discharge it identified Humulin 70/30 insulin was discontinued. New orders for Lantus 20 units every bedtime and Lispro (short acting insulin) give 3 units with meals. Glucometer was sent home with P6 as this was new for him. P6’s Medication Profile, identified on 2/28/22 to 3/31/22 P6 was to receive Humulin 70/30 (intermediate to long-acting insulin) Kwik Pen 20 Units subcutaneously two times daily. On 3/31/22 indicated an order to receive Lantus (long-acting insulin) 20 units every bed time. P6’s plan of care (POC) for certification period of 4/29/22-6/27/22, identified a start of care of 2/28/22. POC indicated P6 was to receive skilled nursing visits on a weekly basis and indicated services were to include medication management to include set up and compliance and assistance with diabetic teaching. P6 had the following orders: to ensure daily testing of blood sugars. P6 had an order to receive Lantus 20 units (U) at bedtime. Check blood sugars before all meals and at bedtime. Did not identify P6’s order for Lispro insulin to be given 3 units with meals. P6’s weekly skilled nurse visits from 4/13/22 to 5/25/22 indicated P6 did not have a glucometer available to utilize and lacked physician notification that orders of monitoring blood sugars were not being followed. P6’s Skilled Nurse Visit (SNV) dated 6/22/22, indicated P6 reported he was out of his Lantus insulin for a few days and took his old 70/30 insulin. Blood sugar was 414. The note did not identify if physician was notified. On 3/2/23, at 1:34 p.m. the director of nursing (DON) stated that P6 should have had the glucometer available in order for agency staff to monitor P6’s blood sugars. DON verified from 3/31/22 to 5/25/22 per weekly skilled nurse visits P6 did not have access to a glucometer to monitor blood sugars and that the physician was not notified when P6’s blood sugars were out of range. DON further stated P6's physician should have been notified that Lantus was unavailable due to P6's history of hospitalization with diabetes management. A policy was requested for physician notification but was not received.

Integrate all orders CFR(s): 484.60(d)(2) Integrate orders from all physicians or allowed practitioners involved in the plan of care to assure the coordination of all services and interventions provided to the patient. This ELEMENT is not met as evidenced by: Based on interview and document reviewed the agency failed to integrate provider orders from the hospital discharge summary to the plan of care to ensure coordination of services to include access to a glucometer and tracking of blood sugars for 1 of 1 patient (P6) reviewed for hospitalizations. P6’s Admission Profile, identified P6 had the diagnoses of Parkinson’s disease (a brain disorder that causes unintended or uncontrollable movements, such as shaking, stiffness, and difficulty with balance and coordination), and Type 2 diabetes mellitus with hyperglycemia (elevated blood sugars) and without complications. P6’s after visit summary (AVS) dated 3/31/22, indicated P6 was hospitalized from 3/28/22 to 3/31/22, indicated P6 presented with blood sugars in the 600’s (extremely high) and was admitted to the intensive care unit (ICU) on a low dose insulin drip. Upon discharge it identified Humulin 70/30 insulin was discontinued. New orders for Lantus 20 units every bedtime and Lispro (short acting insulin) give 3 units with meals. Glucometer was sent home with P6 as this was new for him. P6’s Medication Profile, identified on 2/28/22 to 3/31/22 P6 was to receive Humulin 70/30 (intermediate to long-acting insulin) Kwik Pen 20 Units subcutaneously two times daily. On 3/31/22 indicated an order to receive Lantus (long-acting insulin) 20 units every bed time. P6’s plan of care (POC) for certification period of 4/29/22-6/27/22, identified a start of care of 2/28/22. POC indicated P6 was to receive skilled nursing visits on a weekly basis and indicated services were to include medication management to include set up and compliance and assistance with diabetic teaching. P6 had the following orders: to ensure daily testing of blood sugars. P6 had an order to receive Lantus 20 units (U) at bedtime. Check blood sugars before all meals and at bedtime. The note not identify P6’s order for Lispro insulin to be given 3 units with meals. P6’s weekly skilled nurse visits from 4/13/22 to 5/25/22 indicated P6 did not have a glucometer available to utilize and lacked physician notification that orders of monitoring blood sugars were not being followed. P6’s Skilled Nurse Visit (SNV) dated 6/22/22, indicated P6 reported he was out of his Lantus insulin for a few days and took his old 70/30 insulin. Blood sugar was 414. The note did not identify if physician was notified. On 3/2/23, at 1:34 p.m. the director of nursing (DON) stated that the physician orders were not transcribed from P6’s AVS to the POC and did not include Lispro insulin 3 units to be given with meals. DON stated, "I will have to educate on this to ensure the POC’s are transcribed correctly." A policy was requested for transcription of physician orders but was not received.

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 observation and document review, the agency failed to develop a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases. This had the potential to affect all patients in the agency's care. On 2/28/23, at 3:30 p.m. a policy was requested from the director of nursing (DON) for the Infection Control policy and procedures to review. Upon review of the clinical policy book, the section below the Infection Control tab was completely empty and DON stated she was unaware of where this would be. DON stated she would reach out to a consultant in follow up. A request was also made for tracking and trending documentation, as well as any COVID-19 policies. On 3/1/23, at 1:00 p.m. DON provided an undated policy, titled Infection Control Plan, which lacked information specific to the agency. The header of the pages was titled COMPANY NAME. DON stated she had not reviewed what had been received as of yet. DON stated she was unaware of any tracking or trending of patient infections or illness. DON stated she was unaware of any formalized system of tracking and trending for staff and clients as well. DON stated if a patient was ill, a nurse visit would be recommended. DON stated she was unaware if this was completed by Human Resources (HR)-A. On 3/1/23, at 1:56 p.m. a conference call was held with HR-A, with DON and administrator on site. At that time HR-A described her role as a more of a compliance/educator role. HR-A stated she had nothing to do with Infection Control policy or surveillance of infections for patients nor staff. DON affirmed she had not developed any tracking or trending process for infections of any sort. DON stated she had not been aware of this process being in place since she had taken over as DON approximately three years ago. A review of the undated policy titled Infection Control Plan outlined the following surveillances: Total surveillance-all infections identified in clients and employees; Targeted surveillance-specific infections, populations, or procedures; and Outbreak surveillance-specific infections or infection clusters within multiple individuals at the same time. The policy further identified the agency would implement a process of identifying all infections in the client and/or employee population and evaluate the current control measures or identify an action plan to improve incidence of infections.

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 develop and implement policies and procedures to ensure all staff are fully vaccinated for COVID-19. This had the potential to affect all patients cared for by the agency. On 2/28/23, at 3:30 p.m. COVID-19 policies were requested from the director of nursing (DON). A review of the clinical policy book, the section below the Infection Control tab was completely empty and DON stated she was unaware of where this would be. DON stated she would reach out to consultant in follow up. On 3/1/23, at 1:00 p.m. DON provided surveyor an undated policy, titled Infection Control Plan, which lacked information specific to the agency. The header of the pages was titled COMPANY NAME. DON stated she had not reviewed what had been received as of yet. The DON stated they did not have any formalized tracking system for employee COVID-19 vaccines, but may be done by teh Human Resources (HR)-A. On 3/1/23, at 1:56 p.m. a conference call was held with HR-A, with DON and administrator on site. At that time HR-A described her role was that of a compliance/educator role. HR-A stated she had nothing to do with Infection Control policy or surveillance. At this time, verified current policy for COVID-19 provided was the release of COVID-19 policy from 2020 from MDH and not a policy for their agency. A review of the undated policy titled Infection Control Plan outlined the following surveillances: Total surveillance-all infections identified in clients and employees; Targeted surveillance-specific infections, populations, or procedures; and Outbreak surveillance-specific infections or infection clusters within multiple individuals at the same time. The policy further identified the agency would implement a process of identifying all infections in the client and/or employee population and evaluate the current control measures or identify an action plan to improve incidence of infections. The policy lacked any indication of processes for COVID-19 illness/infection/vaccination/or PPE. A request was made for the exemption policy for COVID vaccination, as well as the matrix or log for staff members vaccination status, in relation to initial vaccination status and boosted status. The facility was not available to track the vaccination status readily, and a matrix had not been yet developed. A request was made for manual calculation of this information. On 3/2/23, at 8:45 a.m. the facility provided the vaccination on their 75 employees. Of the 75 employees, there were 42 unvaccinated staff (56%). Of the 42 unvaccinated staff, there were 31 staff members of the 42 unvaccinated staff members providing care for relatives only in the role of personal care assistants. Additionally, the facility lacked complete information on vaccinated staff members to include the type of vaccine, completion of the vaccine series, and boosted status. The information provided only identified a first dose was given. The facility was unable to provide a policy for vaccination exemption.

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 cared for by the agency. On 2/28/23, at 4:00 p.m. it was noted the posted Clinical Laboratory Improvement Amendments (CLIA) waiver was noted to have an expiration of 8/31/22. On 2/28/23, at 4:00 p.m. the administrator stated he was unaware the waiver had expired and would check to see if perhaps he had it in his file. On 3/1/23, at 1:00 p.m. administrator stated he did not have an updated waiver but had just applied for renewal of the waiver. The director of nursing stated she was unaware of the waiver, however, did state the agency provided patient services including glucose monitoring and check of INR's (International normalized ratio-a test to determine blood clotting).