Every finding on record at Renaissance Home Care Inc

Based on the findings of an unannounced onsite Medicare recertification survey conducted August 21, 2023 through August 23, 2023, Renaissance Home Care, Inc. was found not to be in compliance with the requirements of 42 CFR, Part 418.113, Subpart D, Conditions of Participation: Home Health Agencies -Emergency Preparedness.

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 facility documentation and staff interview (EMP), it was determined the agency failed to establish, maintain and review an emergency preparedness plan to include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. Findings include: Review of facility emergency preparedness binder conducted on 8/21/23 at approximately 2:30 p.m. revealed the following: There was no documented evidence of a facility-based and community-based risk assessment, utilizing an all-hazards approach. An exit conference was conducted on 8/23/23 at approximately 3:00 p.m. with the following staff members: directly with the facility Administrator (EMP1) and via phone the Vice President, Market Expansion and Strategic Operation confirmed the above findings.

Based on the findings of an unannounced onsite Medicare recertification survey conducted August 21, 2023 through August 23, 2023, Renaissance Home Care, 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.

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) documentation, combined governing board/professional advisory committee meeting minutes, and an interview with the administrator the agency failed to demonstrate the presence of systematic data collection and monitoring for infections. Findings include: A review of the agency Professional Advisory Board, Annual Agency Evaluation and Budgetary Review Reports dated February 2022 and February 20, 2023, on 8/22/23 at approximately 9:30 a.m. revealed… “1. Purpose of Professional Advisory Board…b. The purpose of this board is to oversee and evaluate Agency operations including but not limited to the following…vii. Program evaluations…ix. Conduct and overall policy and administrative review.” A review of the agency Section IV-Infection Control, Equipment and Safety Management. Infection Control /Exposure Control revealed “the Agency shall maintain policies and procedures for the care of clients with infectious and/or contagious diseases and for infection control practices by employees which conform with currently accepted standards of care…Infection Control-The goal of the surveillance, prevention and control of the infection program is to improve client health outcomes through identification and risk reduction of device- related and procedure-related infections in clients, and to reduce the risk of transmission of infectious agents among clients, staff and other caregivers.” There was no documented evidence provided by the HHA to support an agency-wide program for the surveillance, identification, prevention, control, data collection of and monitoring of infectious and/or contagious diseases. An exit conference was conducted on 8/23/23 at approximately 3:00 p.m. with the following staff members: directly with the facility Administrator (EMP1) and via phone the Vice President, Market Expansion and Strategic Operation confirmed the above findings.

Laboratory services/CLIA waivers CFR(s): 484.100(c)(1) Laboratory services. If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient's equipment when assisting with self-administered tests. This STANDARD is not met as evidenced by: Based on observation of the office and three (3) home visits and an interview with the agency administrator the agency failed to maintain a Clinical Laboratory Improvement Amendments (CLIA) waiver in order to perform laboratory blood draws within the home as prescribed by the physician for one (1) of three (3) home visits observed. Home visit #1. Findings include: An observation of the displayed agency certificates conducted on 8/21/23 at approximately 11:30 a.m. revealed that the certificate of waiver was not present in the office. A request for review of the certificate revealed that the certificate was not available. Interview with the agency Administrator (EMP1), “We don’t have one.” In preparation for home visits, review of clinical record for Home visit #1, patient CR1 revealed, start of care 8/10/23, certification period 8/10/23 to 10/8/23. “Home Health Certification and Plan of Care contained orders for …PICC (Peripherally inserted central catheter) line care, medication review and bloodwork…patient needs bloodwork and PICC line care” Observation during home visit #1 conducted on 8/22/23 at approximately 9:00 a.m. registered nurse (RN) was observed performing a blood draw from the patient’s PICC line while conducting the home visit. An exit conference was conducted on 8/23/23 at approximately 3:00 p.m. with the following staff members: directly with the facility Administrator (EMP1) and via phone the Vice President, Market Expansion and Strategic Operation confirmed the above findings.

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on agency tour and observation of the agency's supply cabinet and interview with the agency administrator, it was determined that the administrator failed to implement a process ensuring expired supplies were removed from clinician use. Findings include: Tour of the agency occurred on 8/21/23 at approximately 11:00 a.m. Supply cabinet was located in the Administrator’s office. Observation of the supply cabinet found the following expired supplies: BBL Culture Swab Plus collection transport tube (8) expiration date 1/31/23. Small bore Ext. Set with MicroClave (2) expiration date 8/1/23. BD 60 ml syringe (1) expiration date 1/31/23. Amsino Flat Top Irrigation syringe (4) expiration date 7/5/22. Hypodermic Needle 22g x 1.5 inch a box of 71 expiration date 8/2020. Steristrip 3M (10) expiration date 4/2014, (2) expiration date 2/2016. Alcohol Prep Pads (45) expiration date 7/2021. Alcohol Prep Pads (64) expiration date 11/2022. Sting Free Adhesive remover (28) expiration date 12/2020. Zetuvit Plus Silicone (1) expiration date 8/1/23. Hydrocolloid Dressing 1 box of 10, 2 inch x 2 inch thin, expiration date 12/19/22. Silver Calcium Alginate dressing 4 inch x 5 inch (6) expiration date 3/31/23. V. A. C. Whitefoam dressing, large (2) expiration date 5/14/23. Requested policies that related to the supply cabinet or checking for expired supplies from the administrator. Interview with the administrator on 8/21/23, at approximately 11:45 a.m. confirmed that there were no policies or process in place. An exit conference was conducted on 8/23/23 at approximately 3:00 p.m. with the following staff members: directly with the facility Administrator (EMP1) and via phone the Vice President, Market Expansion and Strategic Operation confirmed the above findings.