Every finding on record at Lifeline Home Health Inc

Based on the findings of an unannounced onsite Home Health Agency Medicare Recertification Survey conducted August 14, 2023 through August 17, 2023, Lifeline Home Health Inc. was found not to be in compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.

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 a review of agency policy, the combined Professional Advisory Committee and Governing Board Meeting Minutes, and an interview with the administrator and agency owner, the agency failed to assure that the Emergency Preparedness Plan (EPP) was reviewed and updated every two (2) years. Findings Include: A document titled, "Disaster Plan (Emergency/Disaster Plan)" was reviewed on August 16, 2023 at approximately 3:00 PM. The eight (8) page document did not contain any dates as to when the Emergency Preparedness Plan was originated nor subsequently reviewed. Two documents provided by the home health agency were reviewed on August 16, 2023 at approximately 3:15 PM: Document #1 titled, "LifeLine's Annual Advisory Committee and Directors Program Review, Meeting Notes, Annual Report," dated June 23, 2022, states in part "3. Approval of Annual Program Evaluation: LifeLine's Program Management, oversight of its Home Health Care Services, participation with Independence Waiver, Aging Waiver, OLTL (office of long term living), now Community Health Choices, ODP (office of developmental programs), and Private Pay Services have all been reviewed internally by Administrator and LifeLine believes that we are in compliance with relevant regulations. LifeLine's policies and procedures have been updated when/where needed in compliance with the new regulations through the above-mentioned audits/inspections." The document does not specifically state if the Emergency Preparedness Plan, Policies and Procedures were reviewed in 2022. Document #2 titled, "LifeLine's Annual Advisory Committee and Directors Program Review, Meeting Notes, Annual Report," dated June 23, 2023, also states in part "3. Approval of Annual Program Evaluation: LifeLine's Program Management, oversight of its Home Health Care Services, participation with Independence Waiver, Aging Waiver, OLTL (office of long-term living), now Community Health Choices, ODP (office of developmental programs), and Private Pay Services have all been reviewed internally by Administrator and LifeLine believes that we are in compliance with relevant regulations. LifeLine's policies and procedures have been updated when/where needed in compliance with the new regulations through the above-mentioned audits/inspections." The document does not specifically state if the Emergency Preparedness Plan, Policies and Procedures were reviewed in 2023. An interview with the agency owner was conducted on August 17, 2023 at approximately 2:30 PM. The agency owner confirmed that the aforementioned documents - LifeLine Annual Advisory Committee, Directors Program Review, Meeting Notes, and Annual Report - are intended to be documentation of a combined Professional Advisory Committee Meeting and Governing Board Meeting. The agency owner noted that due to the small size of the agency, these meetings are held as combined meetings. There was no evidence to support that the Emergency Preparedness Plan, Policies and Procedures were reviewed and updated every two (2) years. An interview conducted with the administrator, agency owner, and office manager on August 17, 2023 starting at 2:30 PM confirmed the above findings.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(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:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice 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: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. *[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 the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID 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: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This STANDARD is not met as evidenced by: Based on a review of the Emergency Preparedness Plan (EPP) and an interview with the administrator and agency owner, the agency failed to demonstrate that the EPP was developed using a facility-based and community-based all-hazards risk assessment approach. Findings Include: A review of the Emergency Preparedness Plan (EPP) on August 16, 2023 at 3:00 PM found that the EPP was not developed through a facility-based and community-based risk assessment using an "all-hazards" approach. There was no documented risk assessment in 2021 or 2022. An interview conducted with the administrator, agency owner and office manager on August 17, 2023 starting at 2;30 PM confirmed the above findings.

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on a review of personnel files (PF), agency policy, and an interview with the agency owner and office manager, the agency failed to demonstrate that emergency preparedness training was provided every two (2) years for eight (8) of twelve (12) PF's reviewed: PF#1, PF#2, PF#3, PF#5, PF#6, PF#7, PF#9, and PF#10. Findings include: The agency owner, in an interview conducted on August 15, 2023 at approximately 10:30 AM stated that the home health agency (HHA) provides various in-service trainings once per month. A review of in-service files contained in a file cabinet and catalogued by month from January 2023 to August 2023 was conducted on August 17, 2023 at approximately 11:00 AM. The in-service trainings were as follows: Jan - Quality Management related to the Office of Developmental Programs (ODP) Part 1; February - Quality Management related to the ODP Part 2; March - Everyday Lives; April - ODP Programs; May - Claims and Service Documentation; June - What Is An Incident; July - Office of Long-Term Living (OLTL) Critical Incidents and Adult Protective Services; August - Disaster Plan. None of the in-service trainings from January to August contained a sign-in sheet to denote who attended the monthly in-service trainings. In-service training files for 2022 and 2021 were not available for review. A review of personnel files was conducted on August 15, 2023 starting at approximately 10:40 AM. and again on August 16, 2023 starting at approximately 9:20 AM. The date of hire (DOH) is indicated below. PF#1 DOH 03/28/2008 did not contain any evidence of emergency preparedness training every two (2) years. PF#2 DOH 11/08/2012 did not contain any evidence of emergency preparedness training every two (2) years. PF#3 DOH 04/04/2015 did not contain any evidence of emergency preparedness training every two (2) years. PF#5 DOH 04/13/2017 did not contain any evidence of emergency preparedness training every two (2) years. PF#6 DOH 03/11/2011 did not contain any evidence of emergency preparedness training every two (2) years. PF#7 DOH 06/09/2003 did not contain any evidence of emergency preparedness training every two (2) years. PF#9 DOH 06/20/2020 did not contain any evidence of emergency preparedness training every two (2) years. PF#10 DOH 12/17/2014 did not contain any evidence of emergency preparedness training every two (2) years. An interview conducted with the administrator, agency owner, and office manager on August 17, 2023 starting at 2:30 PM confirmed the above findings.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on a review of the Emergency Preparedness Program documents provided by the agency, and an interview with the administrator and agency owner, the agency failed to provide evidence that the emergency preparedness plan was tested annually. Findings include: A review of the home health agency's emergency preparedness documents conducted on August 16, 2023 at approximately 3:00 PM did not contain any evidence that exercises to test the emergency preparedness plan were conducted in 2021 or 2022. An interview conducted with the administrator, agency owner and office manager on August 17, 2023 starting at 2:30 PM confirmed the above findings.

Based on the findings of an unannounced onsite Home Health Agency Medicare Re-Certification Survey conducted August 14, 2023 through August 17, 2023, Lifeline Home Health, Inc. was found not to be in compliance with the following requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

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 a review of iQIES (Internet Quality Improvement and Evaluation System) reports and an interview with the administrator and agency owner, the agency failed to transmit OASIS (Outcome and Assessment Information Set) Reports to the CMS (Centers for Medicare and Medicaid Services) system. Findings include: A review of iQIES reports, conducted on August 3, 2023 at approximately 2;30 PM, found that there were no reports of any type available for the home health agency (HHA). The agency owner, in an interview conducted on August 15, 2023 at approximately 12:30 PM, confirmed that the HHA has not been submitted OASIS reports to CMS. The agency owner stated that s/he was informed by a third party that patients receiving skilled nursing through the waiver program do not require submission of OASIS data to CMS. The waiver program is a program whereby the federal government "waives" Medical Assistance/Medicaid rules for institutional care in order for Pennsylvania to use the same funds to provide supports and services for people closer to home in their own communities. A second review of iQIES reports was conducted on August 18, 2023 for the time period 01/01/2022 to 12/31/2022 and 01/01/2023 to 08/18/2023. The report - HHA List: No Successful Production Submissions Report - is intended to list HHA's that have had no OASIS submissions. The report found that the HHA had not submitted any OASIS reports to CMS in 2022 or 2023 to date. An interview conducted with the administrator, agency owner and office manager on August 17, 2023 starting at 2:30 PM confirmed the above findings.

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on a review of clinical records (CR), the home health agency's (HHA) patient admission packet, and an interview with the administrator and agency owner, the agency failed to provide the patient with the names, addresses and telephone numbers of the following Federally funded and State funded entities that service the area where the patient resides: Center for Independent Living, Protection and Advocacy Agency, Aging and Disability Resource Center, and Quality Improvement Organization. Four (4) of four (4) CR's did not meet the requirement: CR#1, CR#2, CR#3, and CR#4. A review of the Patient Admission Packet on August 14, 2023 at approximately 2:00 PM found that the Admission Packet, which is provided to patients at the start of care, did not contain the names, addresses and telephone numbers of the following Federally funded and State funded entities that service the area where the patient resides: Center for Independent Living, Protection and Advocacy Agency, Aging and Disability Resource Center, and Quality Improvement Organization. A review of clinical records (CR) was conducted on August 14, 2023 starting at approximately 10:40 AM. The start of care (SOC) is indicated below. CR#1 SOC 08/23/2010 did not contain evidence that the patient received the names, addresses and telephone numbers of the following Federally funded and State funded entities that service the area where the patient resides at the start of care or subsequent to the start of care: Center for Independent Living, Protection and Advocacy Agency, Aging and Disability Resource Center, and Quality Improvement Organization. CR#2 SOC 03/31/2023 did not contain evidence that the patient received the names, addresses and telephone numbers of the following Federally funded and State funded entities that service the area where the patient resides: Center for Independent Living, Protection and Advocacy Agency, Aging and Disability Resource Center, and Quality Improvement Organization. CR#3 SOC 10/23/2011did not contain evidence that the patient received the names, addresses and telephone numbers of the following Federally funded and State funded entities that service the area where the patient residesat the start of care or subsequent to the start of care : Center for Independent Living, Protection and Advocacy Agency, Aging and Disability Resource Center, and Quality Improvement Organization. CR#4 SOC 06/01/2007 did not contain evidence that the patient received the names, addresses and telephone numbers of the following Federally funded and State funded entities that service the area where the patient residesat the start of care or subsequent to the start of care: Center for Independent Living, Protection and Advocacy Agency, Aging and Disability Resource Center, and Quality Improvement Organization. An interview conducted with the administrator, agency owner, and office manager on August 17, 2023 starting at 2:30 PM confirmed the above findings.

Completion of the comprehensive assessment CFR(s): 484.55(b) Standard: Completion of the comprehensive assessment. This STANDARD is not met as evidenced by: Based on a review of clinical records (CR), agency policy, job descriptions, and an interview with the administrator and agency owner, the home health agency (HHA) failed to assure that a comprehensive assessment was documented by a registered nurse for one (1) of four (4) records reviewed: CR#2. Findings Include: A review of the home health agency's policy - Professional and Ancillary Services - was conducted on August 17, 2023 starting at approximately 10:00 AM. The policy reads in part, "professional nursing services shall be performed in accordance with the attending physician's plan of treatment and shall include but not limited to: assessment and regular reassessment of the nursing needs of the patient throughout the course of care." A review of the home health agency's job description for a Registered Nurse was conducted on August 16, 2023 starting at approximately 2:15 PM. The job description states in part, "Responsibilities - Conducts the admission of the patient to the agency..." A review of clinical records was conducted on August 14, 2023 starting at 10:40 AM. The start of care (SOC) and CMS-485 Home Health Certification and Plan of Care Period (CP) are indicated below. CR#2 SOC 03/31/2023 and CP 03/31/2023 to 05/27/2023 contained a hardcopy document titled Comprehensive Adult Nursing Assessment with OASIS (Outcome and Assessment Information Set) Elements completed on 03/29/2023. There was no type of patient identifier on any of the twenty-nine (29) pages of the document. Section M0080 noted that the discipline of the person completing the assessment was a registered nurse, but there was no signature on the document to denote the name of the registered nurse who completed the comprehensive assessment. An interview conducted with the administrator, agency owner and office manager on August 17, 2023 at 2:30 PM confirmed the above findings.

Content of the comprehensive assessment CFR(s): 484.55(c) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: This STANDARD is not met as evidenced by: Based on a review of clinical records (CR) and an interview with the administrator and agency owner, the home health agency (HHA) failed to assure that the comprehensive assessment accurately reflected the patient's status and included minimal information pertinent to the assessment. One (1) of four (4) CR's did not meet the requirement: CR#2. Findings Include: A review of clinical records (CR) was conducted on August 14, 2023 starting at approximately 10:40 AM. The start of care (SOC) and CMS-485 Home Health Certification and Plan of Care Period (CP) are shown below. CR#2 SOC 03/31/2023, CP 03/31/2023 to 05/27/2023 contained a Comprehensive Adult Nursing Assessment with OASIS (Outcome and Assessment Information Set) Elements, completed on 03/29/2023, for a patient who had a primary diagnosis of quadriplegia (paralysis of all four limbs and torso). Much of the comprehensive assessment was incomplete. The patient's primary caregiver and patient representative were not noted. ADL's (Activities of Daily Living) were not assessed. Functional ability and goals were not assessed. Mobility was not assessed. Bowel elimination was not assessed. Strengths and limitations were not assessed. Disorders of the neurological system were not assessed including a check-off area for quadriplegia. The section on urinary elimination had "no problem" documented although the patient had a suprapubic catheter (SPC). The check-off area for the SPC tube was blank, as was the date when the SPC was last changed. A SPC is a device that is inserted into the bladder to drain urine when an individual is unable to do so on their own. Another area on the form (titled urinary incontinence or urinary catheter presence) did document the presence of a "urinary catheter." The drug regimen review was not completed. The section of the form denoting whether the patient was confined to home (homebound) had a "no" checked. The emergency preparedness care planning section was not completed. An interview conducted with the administrator, agency owner, and office manager on August 17, 2023 starting at 2:30 PM confirmed the above findings.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on a review of clinical records, agency policy and an interview with the administrator and agency owner, the agency failed to complete a comprehensive assessment within five (5) days of the end of the certification period for four (4) of four (4) CR's reviewed: CR#1, CR#2, CR#3, and CR#4. Findings Include: A review of the following policy - Professional Plan of Care - conducted on August 17, 2023 starting at 10:00 AM reads in part, "Reassessment occurs upon hospital discharge and at least every sixty (60) days to determine the need for recertification of care and services and when patient's health problems and needs change for skilled nursing patients." A review of clinical records (CR) was conducted on August 14, 2023 starting at 10:40 AM. The start of care (SOC) and CMS-485 Home Health Certification and Plan of Care Period (CP) is shown below. CR#1 SOC 08/23/2010 and CP 07/14/2023 to 09/11/2023 contained no documentation of a comprehensive assessment being completed within 5 days prior to the certification period (CP) beginning 07/14/2023. There was no updated comprehensive assessment contained in the CR. CR#2 SOC 03/31/2023 and CP 03/31/2023 to 05/27/2023 contained no documentation of a comprehensive assessment being completed within 5 days prior to the certification period beginning 05/28/2023. There were no updated comprehensive assessments contained in the CR after the end of the 05/27/2023 certification period although the patient continued to receive skilled nursing services as of 08/17/2023. CR#3 SOC 04/08/2005 and CP 08/01/2023 to 09/29/2023 contained no documentation of a comprehensive assessment being completed within 5 days prior to the certification period (CP) beginning 08/01/2023. There was no updated comprehensive assessment contained in the CR. CR#4 SOC 06/01/2007 and CP 06/01/2023 to 07/30/2023 contained no documentation of a comprehensive assessment being completed within 5 days prior to the certification period (CP) beginning 06/01/2023. There was no updated comprehensive assessment contained in the CR. An interview conducted with the administrator, agency owner, and office manager on August 17, 2023 starting at 2:30 PM confirmed the above findings.

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on a review of clinical records (CR), agency policy, Pennsylvania Department of Health (DOH) Survey Guidelines for 28 Pa. Code §601.31 Acceptance of Patients, Plan of Treatment and Medical Supervision (d)Conformance with Physician Orders, and an interview with the administrator and agency owner, the home health agency (HHA) failed to assure authentication of verbal orders within thirty (30) days from receipt of the order for two (2) of four (4) CR's reviewed: CR#1 and CR#2. Findings Include: A review of the HHA's Policy - Physician's Plan of Treatment/Change Orders was conducted on August 17, 2023 starting at 10:00 AM. The policy reads in part, "The plan of treatment shall be developed within 5 days of the assessment and shall be signed within 30 working days by the attending physician" and "Verbal change orders shall be signed within 28 days. Verbal and change orders shall be maintained in the clinical record." A review of the Pennsylvania Department of Health (DOH) Survey Guidelines for 28 Pa. Code §601.31 Acceptance of Patients, Plan of Treatment and Medical Supervision (d)Conformance with Physician Orders, issued on May 3, 2013, took place on August 11, 2023 at 2:30 PM. The Guidelines state in part, "An oral order not countersigned within 7 days must be accompanied by clearly documented evidence of the agency’s continuing efforts to obtain the countersignature within that timeframe. All contacts and attempts at contact with the prescriber, by any means of communication, must be documented including the date, time, and the signature of the individual making or attempting to make the contact. This notation regarding prescriber contact may be on the assessment, a case communication note, or other document maintained in the clinical record. If documentation of the attempt(s) to obtain the required countersignature is provided as stated herein, no deficiency citation will be issued, though the surveyor may make note of this lacking for a subsequent survey. A deficiency citation will be issued if there is no documentation of any attempt(s) to obtain the required countersignature as explained above. Any oral order not countersigned within 30 days of original issue, regardless of the number of attempts to obtain countersignature, will result in a citation." A review of clinical records was conducted on August 14, 2023 starting at 10:40 AM. The start of care (SOC) is indicated below. CR#1 SOC 08/23/2010 contained verbal orders dated 03/02/2022, 04/24/2022 and 06/20/2022 that were not authenticated within thirty (30) days of receipt of the verbal order from the physician. CR#2 SOC 03/31/2023 contained verbal orders dated 04/05/2023, 04/13/2023 and 04/19/2023 that were not authenticated within thirty (30) days of receipt of the verbal order from the physician. In addition, the CMS-485 Plan of Care for the time period 03/31/2023 to 05/27/2023 had not yet been signed by the physician. An interview conducted with the administrator, agency owner, and office manager on August 17, 2023 starting at 2:30 PM confirmed the above findings.

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on a review of clinical records (CR), agency policy, and an interview with the administrator and agency owner, the home health agency (HHA) failed to assure that the plan of care was reviewed and revised by the physician no less frequently than once every sixty (60) days. One (1) of four (4) CR's did not meet the requirement: CR#2. Findings include: A review of the following policy - Physician's Plan of Treatment/Change Orders - conducted on August 17, 2023 starting at 10:00 AM reads in part, "The plan shall be reviewed by the attending physician in consultation with the Agency's professional staff at such intervals as the patient's condition requires but at least every 62 days." A review of the following policy - Professional Plan of Care - conducted on August 17, 2023 starting at 10:00 AM reads in part, "Reassessment occurs upon hospital discharge and at least every sixty (60) days to determine the need for recertification of care and services and when patient's health problems and needs change for skilled nursing patients." A review of clinical records (CR) was conducted on August 14, 2023 starting at 10:40 AM. The start of care (SOC) and CMS-485 Home Health Certification and Plan of Care Period (CP) are indicated below. CR#2 SOC 03/31/2023 and CP 03/31/2023 to 05/27/2023 did not contain any evidence of updated plans of care after the end of the 05/27/2023 certification period, although the patient continued to receive skilled nursing services as of 08/17/2023. An interview with the administrator, agency owner and office manager on August 17, 2023 starting at 2:30 PM confirmed the above findings.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on a review of home health agency (HHA) documents, governing board/professional advisory committee combined meeting minutes, and an interview with the administrator and agency owner, the HHA failed to demonstrate the involvement in and responsibilities of the governing body in the quality assurance performance improvement program (QAPI). Findings include: A review of policy - Organizational Guidelines - conducted on August 17, 2023 at approximately 12:00 PM reads in part, "Duties of the Board of Directors: The Board of Directors shall.... allocate resources for the implementation of an agency wide quality assurance program and at least annually receive reports and approve the agency quality assurance activities." Two documents provided by the home health agency were reviewed on August 16, 2023 at approximately 3:15 PM: Document #1 titled, "LifeLine's Annual Advisory Committee and Directors Program Review, Meeting Notes, Annual Report," dated June 23, 2022, does not contain any evidence that the committee received quality assurance reports nor approved the HHA's quality assurance activities. Document #2 titled, "LifeLine's Annual Advisory Committee and Directors Program Review, Meeting Notes, Annual Report," dated June 23, 2023, does not contain any evidence that the committee received quality assurance reports nor approved the HHA's quality assurance activities. An interview with the agency owner was conducted on August 17, 2023 at approximately 2:30 PM. The agency owner confirmed that the aforementioned documents - LifeLine Annual Advisory Committee, Directors Program Review, Meeting Notes, and Annual Report - are intended to be documentation of a combined Professional Advisory Committee Meeting and Governing Board Meeting. The agency owner noted that due to the small size of the agency, these meetings are held as combined meetings. An interview conducted with the administrator, agency owner, and office manager on August 17, 2023 starting at 2:30 PM confirmed the above findings.

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 a review of the home health agency's (HHA) infection control documents, combined governing board/professional advisory committee meeting minutes, and an interview with the administrator and agency owner, the agency failed to demonstrate the presence of systematic data collection and monitoring for infections, and failed to present the results of the data collection to the governing body. Findings include: A review of policy - Infection Control - conducted on August 17, 2023 at approximately 10:00 AM found in the HHA's Policy Manual reads in part, "LifeLine Home Health, Inc. tracks major infections to our client population that results in hospitalization and within compliance with participation in government programs. Primarily, these infections may involve the urinary tract system or respiratory systems, but other serious infections may also be tracked as the agency is made aware of each case...These incidents of infection will be tracked in individual client charts and then coordinated for reporting purposes. Reports will be generated to participating government agencies/programs as required for participation. Reports generated to Executive Management will reflect a summary of these infections.... When these reports are coordinated and written, infections will be broken down into Quarters of the Year as follows: 1st Quarter = January 01 through March 31; 2nd Quarter = April 01 through June 30; 3rd Quarter = July 01 through September 30; 4th Quarter = October 01 through December 31. These infections will be reflected in a percentage based on the total amount of infections compared to the total number of clients at the end of each quarter. When trends or patterns of occurrence are identified, they will be specified in reports to Agency Executive Management. Copies of these reports will be made available to The Joint Commission, The Pennsylvania Department of Health...." Two documents provided by the home health agency were reviewed on August 16, 2023 at approximately 3:15 PM: Document #1 titled, "LifeLine's Annual Advisory Committee and Directors Program Review, Meeting Notes, Annual Report," dated June 23, 2022, does not contain any evidence that the committee received reports related to infection control monitoring, data collection or surveillance of any type. Document #2 titled, "LifeLine's Annual Advisory Committee and Directors Program Review, Meeting Notes, Annual Report," dated June 23, 2023, does not contain any evidence that the committee received reports related to infection control monitoring, data collection or surveillance of any type. There was no other evidence provided by the HHA to support surveillance, monitoring and data collection for infections. An interview with the agency owner was conducted on August 17, 2023, at approximately 2:30 PM. The agency owner confirmed that the aforementioned documents - LifeLine Annual Advisory Committee, Directors Program Review, Meeting Notes, and Annual Report - are intended to be documentation of a combined Professional Advisory Committee Meeting and Governing Board Meeting. The agency owner noted that due to the small size of the agency, these meetings are held as combined meetings. An interview with the administrator, agency owner and office manager conducted on August 17, 2023 starting at 2:30 PM confirmed the above findings.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on a review of personnel files (PF), agency policies, and an interview with the administrator, the agency failed to demonstrate the presence of the following: Infection control education provided to staff at periodic intervals consistent with accepted standards of practice. Such education must be provided annually, and as needed to meet the staff's learning needs to provide adequate care; identify infection signs and symptoms; identify routes of infection transmission; appropriately disinfect/sanitize/transport equipment and devices used for patient care; and use proper medical waste disposal techniques. Such education must include instructions on how to implement current infection prevention/treatment practices in the home setting. Eight (8) of twelve (12) PF's did not meet the requirement: PF # 1, 2, 3, 5, 6, 7, 9 and 10. Findings include: A review of agency policies conducted on August 17, 2023 starting at 10:00 AM revealed following: A policy “Administrative Staff” states, “the administrator’s duties shall include but not be limited to the following: ensures appropriate staff education and evaluation.” A review of personnel files (PF) was conducted on August 15, 2023, starting at 10:40 AM and August 16, 2023, at 9:20 AM. The date of hire (DOH) is indicated below. PF# 1 DOH 3/26/08 did not contain evidence of annual infection control education for 2022 and 2021. PF#2 DOH 11/8/12 did not contain evidence of annual infection control education for 2022 and 2021. PF#3 DOH 4/4/15 did not contain evidence of annual infection control education for 2022 and 2021. PF#5 DOH 4/13/17 did not contain evidence of annual infection control education for 2022 and 2021. PF#6 DOH 3/11/11 did not contain evidence of annual infection control education for 2022 and 2021. PF#7 DOH 6/9/03 did not contain evidence of annual infection control education for 2022 and 2021. PF#9 DOH 8/3/2020 did not contain evidence of annual infection control education for 2022 and 2021. PF#10 DOH 12/17/14 did not contain evidence of annual infection control education for 2022 and 2021. An interview conducted with the administrator on August 17, 2023, starting at 2:00 PM confirmed the above findings.

Home health aide qualifications CFR(s): 484.80(a) Standard: Home health aide qualifications. This STANDARD is not met as evidenced by: Based on a review of personnel files (PF) and an interview with the administrator, the agency failed to demonstrate the presence of the following: · A minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse for three (3) of four(4) files reviewed: PF# 9, 11 and 12. · A home health aide competency evaluation by observing an aide's performance of the task with a patient or pseudo-patient and by written examination, oral examination, or after observation of a home health aide with a patient, or with a pseudo-patient as part of a simulation for three (3) of four (4) files reviewed: PF# 9, 11 and 12. Findings include: A review of personnel files (PF) was conducted on August 15, 2023, starting at 10:40 AM and August 16, 2023, at 9:20 AM. The date of hire (DOH) is indicated below. PF#9 DOH 8/3/2020 did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. PF contained competency evaluation written test dated 6/2/2022; however, the test was not graded, does not indicate satisfactory or unsatisfactory, and does not indicate that competency evaluation was performed by a registered nurse. PF did not contain evidence of competency evaluation by observing an aide's performance of the task with a patient or pseudo-patient. PF#11 DOH 3/5/2023 did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. PF contained competency evaluation written test dated 3/5/2023; however, the test was not graded, does not indicate satisfactory or unsatisfactory, and does not indicate that competency evaluation was performed by a registered nurse. PF did not contain evidence of competency evaluation by observing an aide's performance of the task with a patient or pseudo-patient. PF#12 DOH 1/11/2022 did not contain evidence of a minimum of 75 hours of classroom and supervised practical training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing services to an individual under the direct supervision of a registered nurse, or a licensed practical nurse who is under the supervision of a registered nurse. PF contained competency evaluation written test dated 1/11/2022; however, the test was not graded, does not indicate satisfactory or unsatisfactory, and does not indicate that competency evaluation was performed by a registered nurse. PF did not contain evidence of competency evaluation by observing an aide's performance of the task with a patient or pseudo-patient. A review of policies conducted on August 17, 2023 starting at 10:00 AM revealed following: A policy “Administrative Staff” states, “the administrator’s duties shall include but not be limited to the following: employs qualified personnel and ensures appropriate staff education and evaluation.” A policy “Personnel Records/References” reads in part, “personal records shall contained the following:…qualifications.” A form “Competency Evaluation for Home Health Aides” outlines HHA training program subjects. An interview conducted with the administrator on August 17, 2023, starting at 2:00 PM confirmed the above findings.

12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This STANDARD is not met as evidenced by: Based on a review of personnel files (PF) and an interview with the administrator, the agency failed to demonstrate the presence of the following: The HHA (Home Health Aide) 12 hours in-service training during each 12-month period for three (3) of four (4) files reviewed: PF# 9, 10, 12. Findings include: A review of personnel files (PF) was conducted on August 15, 2023, starting at 10:40 AM and August 16, 2023, at 9:20 AM. The date of hire (DOH) is indicated below. PF#9 DOH 8/3/2020 did not contain evidence of The HHA annual 12 hours in-service training for 2023, 2022 and 2021. PF#10 DOH 12/17/2014 did not contain evidence of The HHA annual 12 hours in-service training for 2022, 2021 and 2020. PF#12 DOH 1/11/2022 did not contain evidence of The HHA annual 12 hours in-service training for 2023. An interview conducted with the administrator on August 17, 2023, starting at 2:00 PM confirmed the above findings.

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on a review of personnel files (PF), agency policies, CDC (Centers for Disease Control and Prevention) guideline, Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Fact Sheet, OSHA Bloodborne Pathogens Standard, 29 CFR 1910,1030 and an interview with the administrator, the agency failed to demonstrate the presence of the following: · Initial competency evaluation for five (5) of twelve (12) files reviewed: PF# 4, 8, 9, 11, 12. · Annual competency evaluation for five (5) of twelve (12) files reviewed: PF# 1, 2, 3, 5, 7. · Annual performance evaluation for four (4) of twelve (12) files reviewed: PF# 1, 2, 3, 7. · Screening for mycobacterium tuberculosis (TB) for four (4) of twelve (12) files reviewed: PF# 8, 9, 11, 12. · Orientation for four (4) of twelve (12) files reviewed: PF# 4, 8, 11, 12. · Job description for five (5) of twelve (12) files reviewed: PF# 4, 5, 7, 8, 12. · Agency offered Hepatitis B vaccine for two (2) of twelve (12) files reviewed: PF# 4, 11. · Background checks (PA patch) for one (1) of twelve (12) files reviewed: PF# 11. · HHA initial competency including 75 hours of classroom training for three (3) of twelve (12) files reviewed: PF# 9, 11, 12. · HHA annual 12 hours in-service for three (3) of twelve (12) files reviewed: PF# 9, 10,12. Findings include: A review of agency policy was conducted on 8/17/2023 and revealed following: · Policy “Personnel Records/References” states, “Personnel records shall contain the following: application or resume, job description, qualifications, licensure or certification verification, performance evaluations, PPD, other items and information requires by the Agency, and one work related references, if obtainable. · Policy “Personnel Evaluation” states, “All contractors shall be evaluated by their appropriate supervisor upon completion of 12 months of services and annually thereafter. The evaluation shall include the performance of the individual…. The evaluation report shall become a permanent part of the contractor’s personnel file.” · Policy “Administrative Staff” states, “Administrator’s duties shall include but not be limited to the following: - Employs qualified personnel and ensures appropriate staff education and evaluation. · Policy “Health Requirement” states, “Each contactor serving in a patient care capacity shall have a physical examination within 30 days of employment or the timeframe established by state requirement, whichever is shorter… including a Mantoux test. …The physical examination shall include testing for evidence of freedom from conditions which may prove hazardous to the employee or the patients.” · Policy “Updated TB testing and Screening Policy / Procedure:” dated 10/9/2020 states, Lifeline Home health, Inc. has updated its Policy and Procedure regarding Tuberculosis (TB) Testing per consultation with Surveyors from PA Department of Health, Division of Home Health, in compliance with May 2019 Recommendation from the CDC: 2. Lifeline Home Health, Inc. will implement a two-step process of skin testing for Job Applicants and/or New Hires performing Direct Care Work and Nursing Services are “Negative” to ensure that individuals have not been exposed to TB. 3. For individuals with a History of Positive Results or for individuals with a History of Specific Vaccines known to cause a False Positive Skin Tests, those individuals will be asked to furnish the Agency with a recent Chest X-ray or sent to a Provider for a New Chest X-ray, as may be appropriate. · Policy “LifeLine Staff Criminal History Checks:” dated 8/28/19 states, “(a) LifeLine shall ensure that a criminal history check is obtained for staff prior to hiring and engaging staff with consumers. (c) LifeLine shall apply for a criminal history check for staff prior to hiring. The Centers for Disease Control and Prevention (CDC) and the National TB (Tuberculosis) Controllers Association released updated recommendations for Tuberculosis (TB) screening, testing, and treatment of health care personnel on May 17, 2019. These recommendations update the health care personnel screening and testing section of the 2005 CDC Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Settings. All health care personnel should be screened for TB upon hire (i.e., preplacement). TB screening is a process that includes: a baseline individual TB risk assessment, a TB symptom evaluation, and a TB test (e.g., a TB single blood assay test or a two-step tuberculin skin test (TST), and additional evaluation for TB disease as needed. Health care personnel with a positive TB test result should receive a symptom evaluation and a chest x-ray to rule out TB disease. Additional workup may be needed based on those results. All health care personnel should receive TB education annually. TB education should include information on TB risk factors, the signs and symptoms of TB disease, and TB infection control policies and procedures. (CDC/MMWR/May 17, 2019/Vol.68/No.19). A review of Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Fact Sheet was conducted on August 17, 2023 at approximately 5:00 PM. The fact sheet reads in part, "Hepatitis B virus (HBV) is a pathogenic microorganism that can cause potentially life-threatening disease in humans. HBV infection is transmitted through exposure to blood and other potentially infectious materials (OPIM) as defined in the OSHA Bloodborne Pathogens Standard, 29 CFR 1910.1030. Any workers who have reasonably anticipated contact with blood or OPIM during performance of their jobs are considered to have occupational exposure and to be at risk of being infected. An employer must develop an exposure control plan.... employers must make hepatitis B vaccination available to these workers.... employers must offer the vaccination series to all workers who have occupational exposure. Examples of workers who may have occupational exposure include, but are not limited to, healthcare workers...the vaccine must be offered at no cost to the worker and at a reasonable time and place." A review of OSHA Bloodborne Pathogens Standard, 29 CFR 1910,1030 was conducted on August 17, 2023 at approximately 5:00 PM. Standard 1910.1030b defines Occupational Exposure as "reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties. Standard 19.10.1030(c)(1)(i) states "each employer having an employee(s) with occupational exposure shall establish a written Exposure Control Plan designed to eliminate or minimize employee exposure." Section 1910.1030(f)(1)(i) states, "the employer shall make available the hepatitis B Vaccine and vaccination series to all employee who have occupational exposure." Section 1910.1030(f)(1)(ii)(A) states, "made available at no cost to the employee." Section 1910.1030(F)(1)(ii)(B) states, "made available to the employee at a reasonable time and place." A review of personnel files (PF) was conducted on August 15, 2023, starting at 10:40 AM and August 16, 2023, at 9:20 AM. The date of hire (DOH) is indicated below. PF# 1 DOH 3/26/08 did not contain evidence of Annual competency evaluation for 2022, Annual performance evaluation for 2022. Annual competency dated 10/8/22 was evaluated by an LPN. PF#2 DOH 11/8/12 did not contain evidence of Annual competency evaluation for 2022, Annual performance evaluation for 2022. Annual competency evaluation dated 10/6/22 was not signed by evaluator. Annual performance was evaluated by an LPN. PF#3 DOH 4/4/15 did not contain evidence of Annual competency evaluation for 2022, Annual performance evaluation for 2022. PF#4 DOH 4/15/22 did not contain evidence of Initial competency evaluation, orientation, Job description, Agency offered Hepatitis B vaccine. Job description of staff RN was signed; however, PF did not have a signed copy of job description of administrator. PF contained a blank form of Hepatitis B vaccine offer; however, said form was not signed. PF#5 DOH 4/13/17 did not contain evidence of Annual competency evaluation for 2022 and Job description. PF#7 DOH 6/9/03 indicated personnel applicable for this PF is a staff RN since 2003 and appointed as an alternate administrator since 2022. PF did not contain evidence of Annual competency evaluation for 2022, Annual performance evaluation for 2022, Job description of alternate administrator. Annual competency evaluation did not include evaluator’s signature. Annual performance evaluation was signed by an LPN. PF#8 DOH 1/30/23 did not contain evidence of Initial competency evaluation, Screening for mycobacterium tuberculosis (TB), orientation, Job description. Initial nursing skills test dated 1/30/23 was not graded nor indicated pass or fail. PF contained only one (1) of three (3) pages of agency’s form “Staff Orientation Checklist.” PF#9 DOH 8/3/20 did not contain evidence of Initial competency evaluation, Screening for mycobacterium tuberculosis (TB) HHA initial competency including 75 hours of classroom training, HHA annual 12 hours in-service for 2022 and 2021. Initial competency evaluation test dated 6/2/20 was not graded. PF did not contain second step of TST. PF#10 DOH 12/17/14 did not contain HHA annual 12 hours in-service for 2022 and 2021. PF#11 DOH 3/5/23 did not contain evidence of Initial competency evaluation, Screening for mycobacterium tuberculosis (TB), orientation, Agency offered Hepatitis B vaccine, Background checks including PATCH (Pennsylvania Access To Criminal History), HHA initial competency including 75 hours of classroom training. Initial evaluation test dated 3/15/23 was not graded. Orientation documentation did not have signature of orienter. PATCH has date of 6/1/21 which is older than 1 year prior to hire date. PF#12 DOH 1/11/22 did not contain evidence of Initial competency evaluation, Screening for mycobacterium tuberculosis (TB), Documentation of orientation, Job description, HHA initial competency including 75 hours of classroom training, HHA annual 12 hours in-servicev for 2022. initial competency evaluation test dated 1/11/22 was not graded. Second step of TST is not in PF. Orientation dated 1/11/22 was not signed by orienter. An interview conducted with the administrator on August 17, 2023, starting at 2:00 PM confirmed the above findings.

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 a review of personnel files (PF), new hire blank (template) application packets, and an interview with the administrator and agency owner, the home health agency (HHA) failed to demonstrate that one of the two services provided by the HHA (Skilled Nursing and Home Health Aide) was a direct service. Nineteen (19) of twenty-one (21) PF's did not meet the requirement: PF#1, PF#2, PF#3, PF#4, PF#5, PF#6, PF#7, PF#8, PF#9, PF#10, PF#12, PF#13, PF#14, PF#15, PF#16, PF#17, PF#18, PF#19, and PF#21. Findings Include: A review of the HHA's personnel roster conducted on August 15, 2023 starting at approximately 9:15 AM found that only two services are provided by the HHA: Skilled Nursing Services and Home Health Aide Services. An interview with the home health agency owner (AO) was conducted on August 16, 2023 at approximately 10:30 AM. The AO stated that registered nurses (RN) and licensed practical nurses (LPN) are independent contractors and are not employed directly by the home health agency. The AO stated that home health aides are employed directly by the home health agency and are not independent contractors. A review of a blank (template) application packet provided by the home health agency for home health aides contains several documents including a document titled, "LifeLine (Company) Home Health Contractual Agreement for Aide" reviewed on August 16, 2023 at approximately 3:00 PM states in part, "Aide desires to contract with Company to provide service in accordance with the highest standards of the nursing profession. In consideration of the mutual covenants contained in the Agreement and intending to be legally bound, Company and Aide agree as follows: 1. Relationship of Company and Aide a. It is understood between Aide and Company that the relationship between Aide and Company shall not be considered in anyway, whether direct or indirect, an employment relationship. In all respects, Aide shall be considered an Independent Contractor. In addition it is understood and agreed that Aide shall not be deemed to be employed by Company for the purposes of any federal, state, or local laws with respect to employment or compensation for employment, including but not limited to the taxes levied for contributions required by the Federal Insurance Contributions Act, the withholding provisions of the Internal Revenue Code, any state or local law or ordinance, the Social Security Act, and the Federal Unemployment Insurance Act. Aide hereby agrees to be responsible to have full and complete liability for any and all employment or payroll taxes or contributions imposed by any one of the above laws or ordinances. A review of a blank (template) application packet provided by the home health agency for Licensed Practical Nurses (LPN), reviewed on August 16, 2023 at approximately 3:00 PM contains several documents including a document which states in part, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." A review of a blank (template) application packet provided by the home health agency for Registered Nurses (RN), reviewed on August 16, 2023 at approximately 3:00 PM contains several documents including a document which states in part, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." A review of personnel files was conducted on August 15, 2023 starting at approximately 10:40 AM. and again on August 16, 2023 starting at approximately 9:20 AM. The date of hire (DOH) is indicated below. PF#1 DOH 03/28/2008 contains an agreement between the HHA and the employee dated 03/28/2008 which states in part, "It is understood between Nurse (LPN) and Company that the relationship between Nurse and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Nurse shall be considered as an Independent Contractor." A second document contained in the file, signed by the employee on 03/26/2008 states, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." PF#2 DOH 11/08/2012 contains an agreement between the HHA and the employee dated 11/08/2012 which states in part, "It is understood between Nurse (LPN) and Company that the relationship between Nurse and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Nurse shall be considered as an Independent Contractor." A second document contained in the file, signed by the employee on 11/08/2012 states, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." PF#3 DOH 04/04/2015 contains an agreement between the HHA and the employee dated 04/04/2015 which states in part, "It is understood between Nurse (LPN) and Company that the relationship between Nurse and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Nurse shall be considered as an Independent Contractor." A second document contained in the file, signed by the employee on 04/04/2015 states, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." PF#4 DOH 04/22/2022 contains an agreement between the HHA and the employee dated 04/15/2022 which states in part, "It is understood between Nurse (RN Administrator) and Company that the relationship between Nurse and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Nurse shall be considered as an Independent Contractor." PF#5 DOH 04/13/2017 contains an agreement between the HHA and the employee dated 03/13/2017 which states in part, "It is understood between Nurse (RN) and Company that the relationship between Nurse and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Nurse shall be considered as an Independent Contractor." A second document contained in the file, signed by the employee on 11/08/2012 states, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." PF#6 DOH 03/11/2011 contains an agreement between the HHA and the employee dated 03/11/2011 which states in part, "It is understood between Nurse (LPN) and Company that the relationship between Nurse and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Nurse shall be considered as an Independent Contractor." A second document contained in the file, signed by the employee on 03/11/2011 states, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." PF#7 DOH 06/09/2003 contains an agreement between the HHA and the employee dated June 9 (no year) which states in part, "It is understood between Nurse (RN) and Company that the relationship between Nurse and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Nurse shall be considered as an Independent Contractor." A second document contained in the file, signed by the employee on 02/28/2022 states, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." A third document in the file is a notarized document titled "Workers' Compensation Insurance Coverage Information, which reads, "The undersigned swears or affirms that he/she is not required to provide workers compensation insurance under the provisions of Pennsylvania's Workers' Compensation Law for one of the following reasons, as indicated: Contractor with no employees." The document was notarized on May 6, 2022 and signed by the employee. PF#8 DOH 01/30/2023 contains an agreement between the HHA and the employee dated 01/30/2023 which states in part, "It is understood between Nurse (LPN) and Company that the relationship between Nurse and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Nurse shall be considered as an Independent Contractor." PF#9 DOH 06/20/2020 contains an agreement between the HHA and the employee dated 06/02/2020 which states in part, "It is understood between Aide and Company that the relationship between Aide and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Aide shall be considered as an Independent Contractor." PF#10 DOH 12/17/2014 contains an agreement between the HHA and the employee dated 12/14/2017 which states in part, "It is understood between Aide and Company that the relationship between Aide and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Aide shall be considered as an Independent Contractor." A second document contained in the file, signed by the employee on 12/15/2014 states, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." PF#12 DOH 01/11/2022 contains an agreement between the HHA and the employee dated 01/11/2022 which states in part, "It is understood between Aide and Company that the relationship between Aide and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Aide shall be considered as an Independent Contractor." A second document contained in the file, signed by the employee on 01/11/2022 states, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." PF#13 DOH 01/18/2023 contained several documents pertaining to employment prior to 01/18/2023. A document dated and signed by the employee on 02/07/2011 states, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." A second document dated 12/09/2022 states in part, "It is understood between Aide and Company that the relationship between Aide and Company shall be considered an employment relationship. In addition, it is understood and agreed that Aide shall be deemed to be employed by Company for the purposes of any federal, state, or local laws with respect to employment or compensation for employment, including but not limited to the taxes levied for contributions required by the Federal Insurance Contributions Act, the withholding provisions of the Internal Revenue Code, any state or local law or ordinance, the Social Security Act, and the Federal Unemployment Insurance Act. Aide hereby agrees to be responsible to have full and complete liability for any and all employment or payroll taxes or contributions imposed by any one of the above laws or ordinances." A third document contained in the PF, dated 01/18/2023 reads in part, "It is understood between Aide and Company that the relationship between Aide and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Aide shall be considered as an Independent Contractor. PF#14 DOH 11/29/2018 contains an agreement between the HHA and the employee dated11/29/2018 which states in part, "It is understood between Aide and Company that the relationship between Aide and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Aide shall be considered as an Independent Contractor." A second document contained in the file, signed by the employee on 11/29/2018 states, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." PF#15 DOH 03/18/2023 contains an agreement between the HHA and the employee dated 03/17/2023 which states in part, "It is understood between Aide and Company that the relationship between Aide and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Aide shall be considered as an Independent Contractor." PF#16 DOH 03/10/2023 contains an agreement between the HHA and the employee dated 03/10/2023 which states in part, "It is understood between Aide and Company that the relationship between Aide and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Aide shall be considered as an Independent Contractor." A second document contained in the file, signed by the employee on 03/30/2023 states, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." PF#17 DOH 10/07/2023 contains an agreement between the HHA and the employee dated 07/10/2023 which states in part, "It is understood between Aide and Company that the relationship between Aide and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Aide shall be considered as an Independent Contractor." PF#18 DOH 01/30/2019 contains an agreement between the HHA and the employee dated 01/30/2019 which states in part, "It is understood between Aide and Company that the relationship between Aide and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Aide shall be considered as an Independent Contractor." A second document contained in the file, signed by the employee on 01/30/2019 states, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." PF#19 DOH 04/04/2018 contains an agreement between the HHA and the employee dated 04/04/2018 which states in part, "It is understood between Aide and Company that the relationship between Aide and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Aide shall be considered as an Independent Contractor." A second document contained in the file, signed by the employee on 03/29/2018 states, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." PF#21 DOH 02/09/2021 contains an agreement between the HHA and the employee dated 02/09/2021 which states in part, "It is understood between Aide and Company that the relationship between Aide and Company shall not be considered in any way, whether direct or indirect, an employment relationship. In all respects, Aide shall be considered as an Independent Contractor." A second document contained in the file, signed by the employee on 02/09/2021 states, "I, the undersigned acknowledge that I am an Independent Contractor with LifeLine Home Health and I understand that I am expected to provide my own Workman's Compensation coverage. I will therefore not hold LifeLine Home Health liable in case of an accident or injury to myself while providing services to LifeLine Home Health clients." All employees under a single job description must be direct employees to demonstrate compliance. Although the home health agency reported home health aides to be direct service employees, the personnel files revealed that the job classification for home health aides includes personnel who are direct employees and contractors and therefore, the home health aide service is not considered a direct service but rather a combined service. An interview conducted with the administrator, agency owner, and office manager on August 17, 2023 starting at 2:30 PM confirmed the above findings.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on a review of clinical records (CR), agency policy, and an interview with the administrator and agency owner, the home health agency (HHA) failed to maintain a clinical record that included all of the clinical notes for two (2) of four (4) CR's reviewed: CR#2 and CR#4. Findings include: A review of the home health agency's (HHA) policy manual conducted on August 17, 2023 at 10:00 AM found a policy titled, "Clinical Records Contents for Skilled Nursing Consumers." The policy states in part, "The agency shall maintain a clinical record for each patient which is initiated at the time of the first visit. The record shall contain pertinent past and current medical, nursing, social, and other therapeutic information. The patient's chart shall contain data including but not limited to...Clinical and progress notes (clinical notes are written the day of service delivery and incorporated into the chart at least weekly; progress notes are a summary of care provided over a period of time)." A review of clinical records was conducted on August 14, 2023 starting at 10:40 AM. The Start of Care (SOC) and CMS-485 Home Health Certification and Plan of Care Period (CP) is shown below. CR#2 SOC 03/31/2023 and CP 03/31/2023 to 05/27/2023 contained physician orders for skilled nursing services seven (7) days per week for 16 hours per day. The CR did not contain any clinical visit notes for the following dates (all 2023): 04/01 to 04/03; 04/08 to 04/10; 04/15 to 04/17; 04/22 to 04/24; 04/29 to 05/27. CR#4 SOC 06/01/2002 and CP 06/01/2023 to 07/30/2023 contained physician orders for skilled nursing services eight (8) hours per day up to seven (7) days per week for nine (9) weeks. Services were to be delivered using two (2) home health agencies (LifeLine and another home health agency). The CR did not contain any clinical visit notes for the time period June 1, 2023 to June 30, 2023 nor was there any clarification in the CR as to when the HHA (LifeLine) was to be providing services since two home health agencies were involved in the delivery of skilled nursing services. An interview was conducted with the office manager (OM) on August 17, 2023 at 12:15 PM. The OM stated that s/he contacted the nurse regarding the missing notes. The nurse stated that s/he previously delivered the missing notes to the HHA. The HHA did not have the notes. The OM stated that s/he asked the nurse to provide the carbon copies of the notes which are to be maintained at the patient's home. The nurse stated that s/he discarded the carbon copies of the missing clinical visit notes. An interview conducted with the administrator, agency owner and office manager on August 17, 2023 at 2:30 PM confirmed the above findings.