Every finding on record at Rapha Home Healthcare, Inc.

Based on the findings of an onsite unannounced medicare recertification survey conducted on May 18, 2021 through May 20, 2021 and concluded offsite on May 21, 2021, Rapha Home Healthcare, 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.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on a review of facility policies/procedures, documentation, and interview with the administrator, the facility failed to ensure the emergency preparedness plan included the contact information for agency staff. Findings include: Review of the agency's Emergency Preparedness Plan on 5/19/21 at approximately 12:00 PM. revealed no contact information for the agency staff. During interview on 5/20/21 at approximately 1:00 P.M., the administrator confirmed the above finding.

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), §485.625(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, 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 review of agency Emergency Preparedness doucmentation and interview with the Administrator/Director of Nursing, the agency failed to conduct an exercise to test the emergency plan at least annually. A review of agency Emergency Preparedness plan on 5/20/21, at approximately 11:00 A.M and 5/21/21 at approximately 9:30 AM. revealed no doucmentation of any exercises to test the emergency plan in 2020. Last Exercise to test the emergency plan was conducted on 4/18/2019. An interview with agency Administrator/Director of Nursing was conducted on 5/20/21, at approximately 1:00 P.M. who confirmed the above finding.

Based on the findings of an onsite unannounced medicare recertification survey conducted on May 18, 2021 through May 20, 2021 and concluded offsite on May 21, 2021, Rapha Home Healthcare, Inc.,was found not to be in compliance with the requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies. As a result of the medicare recertification survey, one (1) condition level and eleven (11) standard level deficiencies were cited but did not result in immediate jeopardy.

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 review of clinical records (CRs), policies and procedures and interview with the administrator/director of nursing (DON), the agency failed to 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 within 30 days of completing the assessment of the beneficiary for one (1) of one (1) Clinical Record. (CR#1). Findings include: Review of policies occurred on 5/19/21 at approximately 1:30 PM. Policy titled, "OASIS Transmittals & Data" stated, "The data will be finalized, encoded, and "locked" into the computer software in preparation for transmission within seven days of the OASIS data set completion by the clinician...The agency will transmit accurate, completed, encoded and locked OASIS data for each patient at least monthly..." Review of Clinical records occurred on 5/18/21 from approximately 11 A.M until 1:30 P.M. CR#1. Start of Care: 2/8/21. OASIS Start of Care assessment revealed visit date of 2/8/21. OASIS assessment was unlocked as agency was able to update the date completed during survey. It was also incomplete as multiple pieces of information were missing including: orders for discipline & treatment, initial summary of patient history, and a signature of the registered nurse who completed the assessment. Administrator/DON was unable to show documenation about submission of any OASIS reports including this one reviewed. Interview with the Administrator/Director of Nursing (DON) on 5/20/21 at approximately 1:00 P.M. confirmed the above findings.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on review of clinical records (CRs), policies and procedures and interview with the administrator/director of nursing, the agency failed to ensure that the patient's comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status but no less the last 5 days of every 60 days for seven (7) of seven (7) CRs reviewed (CR #1-7). Findings include: Review of policies occurred on 5/19/21 at approximately 1:30 PM. Policy titled, "Admision Qualifications" stated, "The patient will be accepted on the basis of the following criteria...The patient is under the care of a licensed physician who will provide orders for services, the physician will review the need for and risks of all services and therapies provided before initiation of the services and therapy...There is a written plan of care reviewed and approved by the physician and reviewed at least every (60) days..." Policy titled, "Patient Re-certification" stated, "Re-certification periods are based on 60-day increments. Orders for re-certification will be obtained from the primary care physician. The re-certification visit will be conducted by the Registered Nurse within 5 days of the end of the certification period for patients requiring OASIS...The follow-up recertification OASIS data version will be completed during the recertification visit for all Medicare patients and for all patients 18 years of age or older...The revised plan of care will be forwarded to the physician for signature." Review of Clinical records occurred on 5/18/21 from approximately 11 A.M until 1:30 P.M. CR # 1 (State of Care: 2/8/21) Clinical Record revealed no documentation of an updated comprehensive assessment completed at least every 60 days. Interview with the Administrator/Director of Nursing (DON) on 5/20/21 at approximately 1:00 P.M. confirmed the above findings.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on review of clinical records (CRs), policies and procedures and interview with the administrator/director of nursing, the agency failed to ensure that patient's had a plan of treatment completed for seven (7) of seven (7) CRs reviewed (CR #1-7). Findings include: Review of policies occurred on 5/19/21 at approximately 1:30 PM. Policy titled, "Admision Qualifications" stated, "The patient will be accepted on the basis of the following criteria...The patient is under the care of a licensed physician who will provide orders for services, the physician will review the need for and risks of all services and therapies provided before initiation of the services and therapy...There is a written plan of care reviewed and approved by the physician and reviewed at least every (60) days..." Policy titled, "Processing Referrals" stated, "If the physician does not provide written orders at the time of referral, the RN/Case Manager will contact the patient's physician by telephone for orders to admit to home health services..." Policy titled, "Purpose and Scope" stated, "Services provided directly include Skilled Nursing and Home Health Aid Services...Care is delivered in the patient's home at the physician's ordered frequency, daily and on an on-call as needed basis after hours, on holidays and weekends..." Policy titled, "Patient Re-certification" stated, "Re-certification periods are based on 60-day increments. Orders for re-certification will be obtained from the primary care physician. The re-certification visit will be conducted by the Registered Nurse within 5 days of the end of the certification period for patients requiring OASIS...The follow-up recertification OASIS data version will be completed during the recertification visit for all Medicare patients and for all patients 18 years of age or older...The revised plan of care will be forwarded to the physician for signature." Review of Clinical records occurred on 5/18/21 from approximately 11 A.M until 1:30 P.M. CR # 1 (State of Care: 2/8/21) Clinical Record revealed no documentation of plan of treatment. Patient is receiving Skilled Nursing from agency three times weekly since 2/8/21. There was no documentation that the Registered Nurse communicated with the physician. CR # 2 (Start of Care: 5/14/18). Clinical Record revealed no documentation of plan of treatment. Patient is currently receiving Home health aides 7 hours daily. There was no documentation that the Registered Nurse communicated with the physician. CR # 3 (Start of Care: 10/19/17). Clinical Record revealed no documentation of plan of treatment. Patient is currently receiving Home health aides 5 hours daily. There was no documentation that the Registered Nurse communicated with the physician. CR # 4 (Start of Care: 10/23/17). Clinical Record revealed no documentation of plan of treatment. Patient is currently receiving Home health aides approximately 9 hours daily. There was no documentation that the Registered Nurse communicated with the physician. CR # 5 (Start of Care: 10/18/17). Clinical Record revealed no documentation of plan of treatment. . Patient is currently receiving Home health aides approximately 5 hours daily. There was no documentation that the Registered Nurse communicated with the physician. CR # 6 (Start of Care: 10/1/17). Patient expired on 1/26/20). Clinical Record revealed no documentation of plan of treatment. Patient is currently receiving Home health aides 4-5 hours daily. There was no documentation that the Registered Nurse communicated with the physician. CR # 7 (Start of Care: 9/11/17). Patient expired on 1/29/20). Clinical Record revealed no documentation of plan of treatment. Patient is currently receiving Home health aides 8 hours daily. There was no documentation that the Registered Nurse communicated with the physician. Interview with the Administrator/Director of Nursing (DON) on 5/20/21 at approximately 1:00 P.M. 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 and policy and procedures and interview with the Director of Nursing (DON)/Administrator, it was determined that the agency failed to ensure that a written summary report was completed and sent to the attending physician at least every 60 days for seven (7) of seven (7) clinical records (CR) reviewed (CR# 1-7). Findings include: Review of agency policy on 5/19/21 at approximately 2 PM titled, "Coordination of Care" stated, "The interchange of information will be documented in the patient's medical record...At the time of admission the RN will determine whether other providers are involved in providing services to the patient to ensure that this interchange occurs, The plan of care will be developed by the admitting nurse in conjunction with the physician and other providers of care, the case conference form will also be the Physician Summary and be faxed to the physician every 60 days..." Review of clinical records on 5/18/21 at approximatley 12 PM revealed: CR #1. State of Care (SOC): 2/8/21. revealed no documentation of a written summary report sent to the physician every 60 days. CR #2. SOC: 5/14/18. revealed no documentation of a written summary report sent to the physician every 60 days. CR# 3. SOC: 10/19/17. revealed no documentation of a written summary report sent to the physician every 60 days. CR #4. SOC: 10/23/17. revealed no documentation of a written summary report sent to the physician every 60 days. CR #5. SOC: 10/18/17. revealed no documentation of a written summary report sent to the physician every 60 days. CR #6. SOC: 10/1/17. revealed no documentation of a written summary report sent to the physician every 60 days. CR#7. SOC: 9/11/17. revealed no documentation of a written summary report sent to the physician every 60 days. Interview conducted on 5/20/21 at approximately 1:00 PM with administrator/director of nursing confirmed the above findings.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on review of clinical records (CRs), policies and procedures and interview with the administrator/director of nursing, the agency failed to ensure that patient's had physician orders/home care certification, including frequencies of services, completed prior to providing Home Health services or at anytime since their start of care for seven (7) of seven (7) CRs reviewed (CR #1-7). Findings include: Review of policies occurred on 5/19/21 at approximately 1:30 PM. Policy titled, "Admision Qualifications" stated, "The patient will be accepted on the basis of the following criteria...The patient is under the care of a licensed physician who will provide orders for services, the physician will review the need for and risks of all services and therapies provided before initiation of the services and therapy...There is a written plan of care reviewed and approved by the physician and reviewed at least every (60) days..." Policy titled, "Processing Referrals" stated, "If the physician does not provide written orders at the time of referral, the RN/Case Manager will contact the patient's physician by telephone for orders to admit to home health services..." Policy titled, "Purpose and Scope" stated, "Services provided directly include Skilled Nursing and Home Health Aid Services...Care is delivered in the patient's home at the physician's ordered frequency, daily and on an on-call as needed basis after hours, on holidays and weekends..." Policy titled, "Patient Re-certification" stated, "Re-certification periods are based on 60-day increments. Orders for re-certification will be obtained from the primary care physician. The re-certification visit will be conducted by the Registered Nurse within 5 days of the end of the certification period for patients requiring OASIS...The follow-up recertification OASIS data version will be completed during the recertification visit for all Medicare patients and for all patients 18 years of age or older...The revised plan of care will be forwarded to the physician for signature." Review of Clinical records occurred on 5/18/21 from approximately 11 A.M until 1:30 P.M. CR # 1 (State of Care: 2/8/21) Clinical Record revealed no documentation of Home Health Certification or physican orders for Home Health Servcices. Patient is receiving Skilled Nursing from agency three times weekly since 2/8/21. There was no documentation that the Registered Nurse communicated with the physician. CR # 2 (Start of Care: 5/14/18). Clinical Record revealed no documentation of Home Health Certification or physican orders for Home Health Servcices. Patient is currently receiving Home health aides 7 hours daily. There was no documentation that the Registered Nurse communicated with the physician. CR # 3 (Start of Care: 10/19/17). Clinical Record revealed no documentation of Home Health Certification or physican orders for Home Health Servcices. Patient is currently receiving Home health aides 5 hours daily. There was no documentation that the Registered Nurse communicated with the physician. CR # 4 (Start of Care: 10/23/17). Clinical Record revealed no documentation of Home Health Certification or physican orders for Home Health Servcices. Patient is currently receiving Home health aides approximately 9 hours daily. There was no documentation that the Registered Nurse communicated with the physician. CR # 5 (Start of Care: 10/18/17). Clinical Record revealed no documentation of Home Health Certification or physican orders for Home Health Servcices. Patient is currently receiving Home health aides approximately 5 hours daily. There was no documentation that the Registered Nurse communicated with the physician. CR # 6 (Start of Care: 10/1/17. Patient expired on 1/26/20). Clinical Record revealed no documentation of Home Health Certification or physican orders for Home Health Servcices. Patient is currently receiving Home health aides 4-5 hours daily. There was no documentation that the Registered Nurse communicated with the physician. CR # 7 (Start of Care: 9/11/17. Patient expired on 1/29/20). Clinical Record revealed no documentation of Home Health Certification or physican orders for Home Health Servcices. Patient is currently receiving Home health aides 8 hours daily. There was no documentation that the Registered Nurse communicated with the physician. Interview with the Administrator/Director of Nursing (DON) on 5/20/21 at approximately 1:00 P.M. confirmed the above findings. DON unable to show surveyor any physician orders for above patients (initial or recertification orders). Director of Nursing stated she was incorrectly taking the hospital discharge paperwork as the physican order for any skilled patients (CR#1) and was unaware would need a physican order for any non-skilled patients under this license (CR #2-7). When surveyor asked Administrator/DON how agency knew CR#1 was to receive skilled nursing three times weekly, administator was unable to show any documentation.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based upon review of agency policy, QAPI (Quality Assessment and Performance Improvement) and interview with the office manager, the agency failed to implement, evaluate and maintain an effective, ongoing, Home Health Agency-wide, data-driven QAPI program. Findings included: This CONDITION (484.65) was not met due to the failure: To measure, analyze and track quality indicators including adverse patient events, 484.65 (a) (1) (2) To utilize quality indicator data and develop its Quality Assurance program to monitor the effectiveness and safety of services and quality of care, 484.65 (b) (1) (2) (3) To conduct annual performance improvement projects,, 485. 65 (d) (1) (2) To ensure an ongoing performance program for Quality Improvement and Patient Safety is defined, implemented and maintained, 484. 65 (e) (1) (2) (3) (4)

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based upon review of agency policy, interview with Administrator/Director of Nursing, agency failed to have QAPI program showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. In addition agency failed to measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services and operations. Findings included: Review of agency policy on 5/19/21 at approximately 12 p.m. titled, "Quality Assessment & Performance Improvement" stated, "The agency implements Quality Improvement activities through a coordinated plan. The QA/PI program is an on-going systematic and objective process of the agency and patient care services. Plan: The governing body is ultimately responsible for all activity of the agency, the administrator/supervising nurse will assure that all staff in the QA/PI program shall have sufficient time and resources to collect, monitor analyze and report data. The QI program representation will be from skilled and unskilled disciplines. QI meeting will be held as often as necessary, but no less than once every six (6) months, to address monitoring results and issues identified through the QI process. The QI committee will address areas for improvement that are cost-effective and perform periodic assessment of care and service...Reports of all QI data collection will be analyzed to determine trends and patterns..." When surveyor asked Administrator/Director of Nursing on 5/20/21 at approximately 10 A.M if any QAPI meetings and data collection were documented for any of the past years, Administrator/Director of Nursing replied that there was nothing conducted. Interview with administrator/director of nursing on 5/20/21 at approximately 1:00 P.M confirmed the above findings.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based upon review of agency policy, interview with Administrator/Director of Nursing, agency failed to have QAPI program showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. In addition agency failed to measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services and operations. Findings included: Review of agency policy on 5/19/21 at approximately 12 p.m. titled, "Quality Assessment & Performance Improvement" stated, "The agency implements Quality Improvement activities through a coordinated plan. The QA/PI program is an on-going systematic and objective process of the agency and patient care services. Plan: The governing body is ultimately responsible for all activity of the agency, the administrator/supervising nurse will assure that all staff in the QA/PI program shall have sufficient time and resources to collect, monitor analyze and report data. The QI program representation will be from skilled and unskilled disciplines. QI meeting will be held as often as necessary, but no less than once every six (6) months, to address monitoring results and issues identified through the QI process. The QI committee will address areas for improvement that are cost-effective and perform periodic assessment of care and service...Reports of all QI data collection will be analyzed to determine trends and patterns..." When surveyor asked Administrator/Director of Nursing on 5/20/21 at approximately 10 A.M if any QAPI meetings and data collection were documented for any of the past years, Administrator/Director of Nursing replied that there was nothing conducted. Interview with administrator/director of nursing on 5/20/21 at approximately 1:00 P.M confirmed the above findings.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on review of agency documentation and interview with office manager, the agency failed to maintain documentation to demonstrate performance improvement projects conducted annually at the HHA (home health agency). Findings included: Review of agency policy on 5/19/21 at approximately 12 p.m. titled, "Quality Assessment & Performance Improvement" stated, "The agency implements Quality Improvement activities through a coordinated plan. The QA/PI program is an on-going systematic and objective process of the agency and patient care services. Plan: The governing body is ultimately responsible for all activity of the agency, the administrator/supervising nurse will assure that all staff in the QA/PI program shall have sufficient time and resources to collect, monitor analyze and report data. The QI program representation will be from skilled and unskilled disciplines. QI meeting will be held as often as necessary, but no less than once every six (6) months, to address monitoring results and issues identified through the QI process. The QI committee will address areas for improvement that are cost-effective and perform periodic assessment of care and service...Reports of all QI data collection will be analyzed to determine trends and patterns..." When surveyor asked Administrator/Director of Nursing on 5/20/21 at approximately 10 A.M if any QAPI meetings and data collection were documented for any of the past years, Administrator/Director of Nursing replied that there was nothing conducted. Interview with administrator/director of nursing on 5/20/21 at approximately 1:00 P.M 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 review of policy and procedure, documention and interview with the office manager, the agency's governing body failed to define and implement an ongoing QAPI (quality assessment and program improvement) program for the purpose of quality improvement and patient safety; failed to ensure the HHA's (home health agency) QAPI efforts addressed priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; failed to ensure that clear expectations for patient safety are established, implemented, and maintained. Findings included: Review of agency policy on 5/19/21 at approximately 12 p.m. titled, "Quality Assessment & Performance Improvement" stated, "The agency implements Quality Improvement activities through a coordinated plan. The QA/PI program is an on-going systematic and objective process of the agency and patient care services. Plan: The governing body is ultimately responsible for all activity of the agency, the administrator/supervising nurse will assure that all staff in the QA/PI program shall have sufficient time and resources to collect, monitor analyze and report data. The QI program representation will be from skilled and unskilled disciplines. QI meeting will be held as often as necessary, but no less than once every six (6) months, to address monitoring results and issues identified through the QI process. The QI committee will address areas for improvement that are cost-effective and perform periodic assessment of care and service...Reports of all QI data collection will be analyzed to determine trends and patterns..." When surveyor asked Administrator/Director of Nursing on 5/20/21 at approximately 10 A.M if any QAPI meetings and data collection were documented for any of the past years, Administrator/Director of Nursing replied that there was nothing conducted. Interview with administrator/director of nursing on 5/20/21 at approximately 1:00 P.M 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), review of policies and procedures, and an interview with the Director of Nursing/Administrator, the agency did not follow its policies: Agency failed to conduct Pennsylvania State criminal background check prior to employment for two (2) of six(6) personnel files reviewed (PF #1 & 4) Findings include: A review of policy occurred on 5/19/21 at approximatley 2 PM. Policy titled, "Background Check" stated, "It shall be the policy of this Agency to obtain a criminal history background screening from the Pennsylvania State Police Patch Program on all individuals prior to an offer temporary or permanent employment. It accordance with the Older Adults Protective Services Act (OAPSA), if an employee or applicant has not been a resident for the two years immediately preceding the employment application, a federal criminal history record must also be obtained..." A review of the personnel files was conducted on 5/19/21 between approximately 9:30 A.M. to 11:30 AM. PF #1, Date of Hire: 7/25/17. There was documentation that a Pennsylvania state criminal background check was completed on 5/22/18 which is after the date of hire. PF# 4, Date of Hire: 10/14/19. There was documentation that a Pennsylvania state criminal background check was completed on 5/18/21 which is after the date of hire. Interview with the Adminstrator/Director of Nursing (PF #3) on 5/20/21 at approximately 1:00 PM confirmed the above findings

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on review of clinical records (CRs), policies and procedures and interview with the administrator/director of nursing, the agency failed to ensure that patient's had discharge summary sent to the physican within within 5 business days of the patient's discharge for two (2) of two (2) discharge patients reviewed (CR #6 and 7). Findings include: Review of policies occurred on 5/19/21 at approximately 1:30 PM. Policy titled, "Patient Discharge" stated, "On the day of discharge the RN conducting the visit will complete the OASIS, if applicable. The physician will be made aware that a copy of the discharge summary is available if she/he desires to receive one..." Review of Clinical records occurred on 5/18/21 from approximately 11 A.M until 1:30 P.M. CR # 6 (Start of Care: 10/1/17. Patient expired on 1/26/20). Clinical Record revealed no documentation that the physician was made aware that the patient passed away/discharged from agency. CR # 7 (Start of Care: 9/11/17. Patient expired on 1/29/20). Clinical Record revealed no documentation that the physician was made aware that the patient passed away/discharged from agency. Interview with the Administrator/Director of Nursing (DON) on 5/20/21 at approximately 1:00 P.M. confirmed the above findings.