Gateway Home Health Care

“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 on record review and interview, the agency failed to develop a patient centered QAPI Program for 15 current patients. This failed practice had the potential to place all current patients and employees at risk for insufficient self-monitoring and efforts to improve care, services and operations. (See G642) Based on record review and interview, the agency failed to ensure the utilization of QAPI data to improve program effectiveness, quality of patient care and overall program improvement. for 15 current patients. This failed practice had the potential to place all patients at risk of repeated agency mishaps, ineffective management of care and poor quality of care. (See G644) Based on record review and interview, the agency failed to develop performance improvement activities that focused on high-risk problem areas for 15 current patients. This failed practice had the potential to place all current patients at risk of repeated unidentified, unexplored and unresolved agency problems that remained un-addressed within the QAPI program. (See G646) Based on record review and interview, the agency failed to develop PIPS to track adverse patient events for 15 current patients. This failed practice had the potential to place all current patients at increased risk for avoidable events such as increased falls and secondary infections. (See G654) Based on record review and interview, the agency failed to document performance improvement within the QAPI Program for all 15 current patients. This failed practice had the potential to place all current patients at risk of poor outcomes and quality of care. (See G656) Based on record review and interview, the agency failed to document PIPs conducted through their QAPI Program for all employees and 15 current patients. This failed practice placed all current patients at risk for problem areas not addressed or resolved. (See G658) Based on record review and interview, the agency failed to ensure an ongoing, comprehensive QAPI program was approved by the governing body. for all 15 current patients. This failed practice had the potential to place all current patients, all future patients and all employees at increased risk for unresolved and unidentified health, safety and organizational issues. (See G660)”

“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 record review and interview, the agency failed to ensure the development of a facility-based risk assessment for all employees and all 15 patients. Findings: A review of emergency preparedness records showed no Agency or community-based Disaster Assessments. On 11/13/24 at 9:05 pm, Staff A stated the risk assessment had not been completed.”

“EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to document emergency drills for the 15 current patients and all employees. Findings: A review of Emergency Preparedness and administrative records showed no annual Emergency Preparedness Tabletop Exercise, no community-based exercise and no full-scale exercise to demonstrate staff knowledge of emergency procedures for 2019, 2020, 2021, 2022, 2023, and from January 1 - November 13, 2024. On 11/13/18 at 9:10 pm, Staff A stated she did not have the documented drills available for 2019, 2020, 2021, 2022, 2023, and from January 1 - November 13, 2024.”

“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 on record review and interview, the agency failed to ensure the utilization of QAPI data to improve program effectiveness, quality of patient care and overall program improvement. for all 15 current patients. This failed practice had the potential to place all current patients at risk of repeated agency mishaps, ineffective management of care and poor quality of care. Findings: A review of administrative records showed no: 1) Ongoing and comprehensive QAPI program 2) Data analysis of QAPI data 3) QAPI data On 11/13/24 at 9:15 pm, Staff A stated QAPI was not complete.”

“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 on record review and interview, the agency failed to ensure the utilization of QAPI data to improve program effectiveness, quality of patient care and overall program improvement. for all 15 current patients. This failed practice had the potential to place all current patients at risk of repeated agency mishaps, ineffective management of care and poor quality of care. Findings: A review of administrative records showed no QAPI program. Documentation showed no processes in place for program development or implementation. Requests for QAPI produced fall records and infection records compiled on the software the agency uses. On 11/13/24 at 9:15 pm, Staff A stated QAPI was not complete.”

“Program activities CFR(s): 484.65(c) (1) The HHA’s performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop performance improvement activities that focused on high-risk problem areas for all current 15 patients. This failed practice had the potential to place all current patients at risk of repeated unidentified, unexplored and unresolved agency problems that remained un-addressed within the QAPI program. A review of administrative records showed no QAPI Program. Documentation showed no processes in place for program development or implementation. On 11/13/24 at 9:15 pm, Staff A stated QAPI was not complete.”

“Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to develop PIPS to track adverse patient events for all 15 current patients. This failed practice had the potential to place all current patients at increased risk for avoidable events such as increased falls and secondary infections. A review of administrative records showed no PIPs. Documentation showed no processes in place for program development or implementation. Requests for PIP records were unmet and the agency was unable to provide documentation or records which tracked patient adverse events. On 11/13/24 at 9:15 pm, Staff A stated QAPI was not complete.”

“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 record review and interview, the agency failed to document performance improvement within the QAPI Program for all 15 current patients. This failed practice had the potential to place all current patients at risk of poor outcomes and quality of care. Finding: A review of records showed no PIPs initiated or documented. On 11/13/24 at 9:15 pm, Staff A stated QAPI was not complete.”

“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 record review and interview, the agency failed to ensure an ongoing, comprehensive QAPI program was approved by the governing body all 15 current patients. This failed practice had the potential to place all current patients, all future patients and all employees at increased risk for unresolved and unidentified health, safety and organizational issues. Findings: A review of administrative records showed no governing body approval or oversight of the QAPI Program. On 11/13/24 at 9:15 pm, Staff A stated QAPI was not complete.”

“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 record review and interview, the agency failed to ensure CHHA completion of 12 hours of annual training for two (CHHA #1 and 2) of two CHHA. Findings: CHHA #1 A review of personnel records showed nine hours of training from N0vember 2023 - November 2024. On 11/13/23 at 8:43 am, Staff A stated she was unable to provided the documentation for all 12 required hours of training in the last 12 months for CHHA #1.”

“Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans, and its quality assessment and performance improvement program. This Standard is not met as evidenced by: Based on record review and interview, the agency failed to ensure the governing body provided oversight of agency operations and programs for 15 current patients and all employees. Findings: A review of policy and procedure, QAPI documentation and administrative records showed no: 1) Governing body review and approval of an annual budget for 2023. 2) Governing body review and approval of Policy and Procedure for 2023. On 11/13/18 at 9:00 am, Staff A stated there was no documentation of the Governing body approval of the annual budget or policies and procedures.”

“Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure SN frequencies were followed as ordered for one (Pt #3) of seven patients. Findings: Pt #3 A review of the POC dated 09/08/24 to 11/06/24 showed orders for a SN frequency of three times a week for eight weeks and then twice a week for one week. A review of visit notes showed two SN visits (two completed visits) the week of 09/22/24 - 09/28/24. Clinical documentation showed no orders to reduce the SN frequency, no refusal of visits by the patient or family/caregiver and no missed visit notes for the week of 09/22/24 - 09/28/24. On 11/13/24 at 10:23 am, Staff B stated, the ordered SN frequency was not followed for Pt #3.”