Every finding on record at In-Home Lab Connection Inc

On 7/17/23-7/18/23, a survey for compliance with Appendix Z, Emergency Preparedness Requirements for home care agencies, §484.102 was conducted during a standard recertification survey. The facility was NOT in compliance. The Condition of Participation: Emergency Preparedness 42 CFR was not met at E0001.

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must 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: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on interview and document review the licensee failed to develop and maintain an Emergency Preparedness (EP) plan that must be reviewed and updated at least annually. The plan must also do the following: be based on and include a documented, facility and community-based risk assessment (utilizing an all-hazards approach), include strategies for addressing emergency events identified by the risk assessment (addressing patient population), and include a process for cooperation and collaboration with local, tribal, regional, state, and federal EP officials. The agency failed to meet the Conditions of Participation (CoP) for E0001. The facility's EP plan dated 9/1/2020, included one sheet of paper titled In-Home Lab Connections (IHLC) Employee & Client Emergency Plan. An Emergency Preparedness Policy and Plan were not included. During an interview on 7/18/23 at 3:00 p.m., the Chief Operations Officer (COO)/administrator verified he had not developed an EP program that included all the elements required by state/federal regulations. He further stated, "I haven't kept up with it." The agency failed to meet the Conditions of Participation (CoP) for E0001. See E0004: Based on document review and interview, the agency failed to develop and maintain an Emergency Preparedness (EP) program to include all of the elements under the standard. The plan was not reviewed or revised to meet the requirements. This had the potential to affect the one current patient and any subsequent patients admitted to the HHA. See E0013: Based on interview and document review the licensee failed to develop and implement EP policies and procedures, review and update them annually, and ensure they address the following: the plan for clients during a natural or man-made disaster, procedures to inform state and local emergency preparedness officials about clients in need of evacuation from their residence, procedures to follow up with on-duty staff and clients to determine services needed in the event there was an interruption in services during or due to an emergency, a system of medical documentation that preserves clients information, and the use of volunteers in an emergency. See E0029: Based on interview and document review the licensee failed to develop and maintain an EP communication plan that complies with federal, state, and local laws, review and update annually, and include the following: names/contact information for staff, entities providing services, client's physician's, volunteers, and emergency officials. A primary/alternative means of communication, continuity of care, and a means of providing information about the client's general condition, location, and the licensee's ability to provide assistance. See E0036: Based on interview and document review the licensee failed to develop and maintain an EP training and testing program. This had to the potential to affect any patients cared for by the agency.

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 document review and interview, the agency failed to develop and maintain an Emergency Preparedness (EP) program to include all of the elements under the standard. The plan was not reviewed or revised to meet the requirements. This had the potential to affect the one current patient and any subsequent patients admitted to the HHA. The licensee's EP plan dated 9/1/2020, included one sheet of paper titled In-Home Lab Connections (IHLC) Employee & Client Emergency Plan and included the following: 1) Fire: RACE-PASS and what the letters stood for (rescue, alarm, contain, extinguish, pull, aim, squeeze, and sweep 2) Severe Weather-in the office, in your car, and at the patient site. 3) medical categories to categorize clients and employees to triage response to major medical events. The three categories are condition, care, and transport. 4) Community Catastrophe/major disaster: respond to the recall plan, contact and provide emergency care for your clients in the order designated in triage, and regional response will be coordinated through Hennepin County Medical Center. During an interview on 7/18/23 at 3:00 p.m., the Chief Operations Officer (COO)/administrator verified he had not developed an EP program that included all the elements required by state/federal regulations. He further stated, "I haven't kept up with it." The administrator was unable to provide any EP program.

Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [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. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility 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 annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization 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 address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility 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. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility's geographic area. This STANDARD is not met as evidenced by: Based on interview and document review the licensee failed to develop and implement EP policies and procedures, review and update them annually, and ensure they address the following: the plan for clients during a natural or man-made disaster, procedures to inform state and local emergency preparedness officials about clients in need of evacuation from their residence, procedures to follow up with on-duty staff and clients to determine services needed in the event there was an interruption in services during or due to an emergency, a system of medical documentation that preserves clients information, and the use of volunteers in an emergency. The licensee's EP plan dated 9/1/2020, included one sheet of paper titled In-Home Lab Connections (IHLC) Employee & Client Emergency Plan and included the following: 1) Fire: RACE-PASS and what the letters stood for (rescue, alarm, contain, extinguish, pull, aim, squeeze, and sweep 2) Severe Weather-in the office, in your car, and at the patient site. 3) medical categories to categorize clients and employees to triage response to major medical events. The three categories are condition, care, and transport. 4) Community Catastrophe/major disaster: respond to the recall plan, contact and provide emergency care for your clients in the order designated in triage, and regional response will be coordinated through Hennepin County Medical Center. During an interview on 7/18/23 at 3:00 p.m., the Chief Operations Officer (COO)/administrator verified he had not developed an EP program that included all the elements required by state/federal regulations. He further stated, "I haven't kept up with it."

Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (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]. This STANDARD is not met as evidenced by: Based on interview and document review the licensee failed to develop and maintain an EP communication plan that complies with federal, state, and local laws, review and update annually, and include the following: names/contact information for staff, entities providing services, client's physician's, volunteers, and emergency officials. A primary/alternative means of communication, continuity of care, and a means of providing information about the client's general condition, location, and the licensee's ability to provide assistance. The licensee's EP plan dated 9/1/2020, included one sheet of paper titled In-Home Lab Connections (IHLC) Employee & Client Emergency Plan and included the following: 1) Fire: RACE-PASS and what the letters stood for (rescue, alarm, contain, extinguish, pull, aim, squeeze, and sweep 2) Severe Weather-in the office, in your car, and at the patient site. 3) medical categories to categorize clients and employees to triage response to major medical events. The three categories are condition, care, and transport. 4) Community Catastrophe/major disaster: respond to the recall plan, contact and provide emergency care for your clients in the order designated in triage, and regional response will be coordinated through Hennepin County Medical Center. During an interview on 7/18/23 at 3:00 p.m., the Chief Operations Officer (COO)/administrator verified he had not developed an EP program that included all the elements required by state/federal regulations. He further stated, "I haven't kept up with it."

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 licensee failed to develop and maintain an EP training and testing program. This had to the potential to affect any patients cared for by the agency. The licensee's EP plan dated 9/1/2020, included one sheet of paper titled In-Home Lab Connections (IHLC) Employee & Client Emergency Plan and included the following: 1) Fire: RACE-PASS and what the letters stood for (rescue, alarm, contain, extinguish, pull, aim, squeeze, and sweep 2) Severe Weather-in the office, in your car, and at the patient site. 3) medical categories to categorize clients and employees to triage response to major medical events. The three categories are condition, care, and transport. 4) Community Catastrophe/major disaster: respond to the recall plan, contact and provide emergency care for your clients in the order designated in triage, and regional response will be coordinated through Hennepin County Medical Center. During an interview on 7/18/23 at 3:00 p.m., the Chief Operations Officer (COO)/administrator verified he had not developed an EP program that included all the elements required by state/federal regulations. He further stated, "I haven't kept up with it."

On 7/17/23-7/18/23 a recertification survey was conducted. This resulted in a partial extended survey at In-Home Lab Connections. 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: 1 No home visits were conducted. 4064 Olivine Drive Eagan, MN 55122 Hours of Operation: 8:00 a.m.- 5:00 p.m. Records reviewed: 1

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on interview and document review the licensee failed to ensure each client who received home health services had a written, individualized plan of care (POC) that was periodically reviewed (every 60 days) and signed by a physician for 1 of 1 client (C1) reviewed for POC. During an interview on 7/17/23 at 10:08 a.m., the Chief Operation Officer (COO)/administrator verified C1's POC with a certification period of 3/26/23-5/24/23 was not current stating "we are behind on our 485's [POC] and assessments." He further verified the POC was not signed by the physician. During a follow up interview on 7/18/23 at 10:30 a.m., the COO/administrator stated the process for ensuring the physician periodically (every 60 days) reviews and signs the POC was to send a fax to the primary physician for a signature, then if they don't respond, send another fax, and if it gets to be too long, he will call. He also stated there was no specific amount of time he would wait in between faxes, but he should be following up on it every couple of days. The licensee's policy on nursing care plans (undated) indicated following the initial registered nursing (RN) assessment, a POC will be developed by the RN with the client and/or caregiver within 5 days of initiation of services and within 5 days preceding a 60-day recertification.

Skilled services furnished CFR(s): 484.105(f) Standard: Services furnished. Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are made available on a visiting basis, in a place of residence used as a patient's home. An HHA must provide at least one of the services described in this subsection directly, but may provide the second service and additional services under arrangement with another agency or organization. This STANDARD is not met as evidenced by: Based on interview and document review the licensee failed to provide skilled nursing services and at least one other therapeutic service to their clients. The licensee's Home Health Agency Survey and Deficiencies Report (CMS-1572) (undated) indicated, its current employees consisted of a registered nurse, a licensed practical nurse, and 5 Phlebotomists. During an interview of 7/17/23 at 9:15 a.m., the Chief Operating Officer (COO)/administrator stated he only had one client receiving skilled nursing services and the rest of his clients were in home blood draws done by Phlebotomists. He further stated he did not offer any other services. During a follow up interview on 7/18/23 at approximately 1:00 p.m., the COO/administrator stated he received a text message from RN-A that she was no longer his employee.