Every finding on record at Lehigh Valley Therapy Inc

Based on the findings of an unannounced onsite Medicare recertification survey completed November 4, 2021, Lehigh Valley Therapy, 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), §485.625(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 review of the agency emergency preparedness plan and an interview with the agency Administrator, the agency failed to ensure the plan was updated at least every 2 years for one (1) of one (1) emergency preparedness plans (EPP) reviewed (EPP#1). Findings include: Agency policy/procedures for the emergency preparedness plan was requested on November 3, 2021 at approximately 11:00 a.m. No specific policy provided. A review of the EPP was conducted on November 3, 2021 at approximately 11:30 a.m. revealed the following: EPP#1: No documentation provided of the agency updating the EPP at least every two years. Per the Administrator, the last EPP update was on 01/28/19. (>24 months). An interview conducted with agency Administrator on November 3, 2021 at approximately 12:30 p.m. confirmed the above findings.

Based on the findings of an unannounced onsite Medicare recertification survey completed November 4, 2021, Lehigh Valley Therapy, 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.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on review of clinical records and an interview with the agency Administrator, the agency failed to complete the initial assessment visit within 48 hours of referral, or within 48 hours of the patients return home, or on the physician-ordered start of care date for two (2) of seven (7) clinical records (CR#1, CR#3). Findings include: Agency policy/procedures for the nurse conducting the initial visit was requested on November 3, 2021 at approximately 11:00 a.m. No specific policy provided. A review of CRs was conducted on November 3, 2021 at approximately 9:00 a.m. The patients start of care (SOC) is listed below. CR#1 SOC 09/20/21: Initial Intake from (Hospital) for skilled nursing patient care 09/15/21, "Anticipate discharge tomorrow." Agency 'Referral accepted date' 09/15/21, "Yes, willing to accept patient." No physician ordered start of care date specified. Documentation of initial assessment visit by registered nurse visit on 09/20/21. (5 days). CR#3 SOC 09/23/21: Initial Intake from (Hospital) for skilled nursing patient care 09/08/21 with revision date of 09/10/21. "Discharge is now 09/17." Agency 'Referral accepted date' 09/10/21, "Yes, willing to accept patient." No physician ordered start of care date specified. Documentation of initial assessment visit by registered nurse visit on 09/23/21. (13 days). An interview conducted with agency Administrator on November 3, 2021 at approximately 12:30 p.m. confirmed the above findings.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on a review of agency policy, review of clinical records, and an interview with the agency Administrator, agency failed to ensure the plan of care included the frequency and duration of visits to be made for seven (7) of seven (7) clinical records (CR) reviewed (CR#1-CR#7). Findings Include: Agency policy/procedures reviewed on November 3, 2021 at approximately 11:00 a.m. Policy Plan of Care-CMS #485 and Physician Orders' 'Procedure' (4) "The individualized plan of care must include the following: "............. The frequency and duration of visits to be made." A review of CRs was conducted on November 3, 2021 at approximately 9:00 a.m. The patients start of care (SOC) is listed below. CR#1 SOC 09/20/21: Patients certification of the Plan of Care for the period of 09/20/21-11/18/21 reviewed. 'Orders for Discipline and Treatment' "Frequency': SN (skilled nurse) Frequency: "1-3 weekly." PT (physical therapy) Frequency: "1-3 weekly." No duration specified. CR#2 SOC 10/25/21: Patients certification of the Plan of Care for the period of 10/25/21-12/23/21 reviewed. 'Orders for Discipline and Treatment' "Frequency': PT Frequency: "PT 1-3 x week." OT (occupational therapy) Frequency: "1-3 weekly." No duration specified. CR#3 SOC 09/23/21: Patients certification of the Plan of Care for the period of 09/23/21-11/21/21 reviewed. 'Orders for Discipline and Treatment' "Frequency': SN Frequency: "SN 1-3 week." PT Frequency: "PT 1-3 week." HHA (home health aide) Frequency: "HHA 1-3 x week." No duration specified. CR#4 SOC 09/19/21: Patients certification of the Plan of Care for the period of 09/19/21-11/17/21 reviewed. 'Orders for Discipline and Treatment' "Frequency': SN Frequency: "SN, prn (as needed)." PT Frequency: "PT 1-3 week and prn." No frequency of prn, no duration specified. CR#5 SOC 07/22/21: Patients certification of the Plan of Care for the period of 09/20/21-11/18/21 reviewed. 'Orders for Discipline and Treatment' "Frequency': SN Frequency: "1-3 weekly." No duration specified. CR#6 SOC 10/01/21: Patients certification of the Plan of Care for the period of 10/01/21-11/24/21 reviewed. 'Orders for Discipline and Treatment' "Frequency': PT Frequency: "1-3 weekly." No duration specified. CR#7 SOC 06/23/20: Patients certification of the Plan of Care for the period of 10/16/21-12/14/21 reviewed. 'Orders for Discipline and Treatment' "Frequency': PT Frequency: "1-3 weekly." HHA Frequency: 1-3 x week, prn." No frequency of prn, no duration specified. An interview conducted with agency Administrator on November 3, 2021 at approximately 12:30 p.m. 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 agency policy, observations, and an interview with the agency Administrator, the agency failed to ensure that everyone entering the health care facility is screened and triaged for COVID-19 for one (1) of one (1) observations (Observation #1) and one (1) of one (1) interviews (Interview #1) and failed to maintain a coordinated agency-wide program for the surveillance of communicable disease by failing to ensure all staff are screened and triaged for COVID-19 for one (1) of one (1) interviews (Interview #2). Findings Include: Pennsylvania Department of Health 'Health Alert Network' dated August 7, 2020 'Subject' 'Update: Interim Infection Prevention and Control Recommendations for Patients with known or Patients Under Investigation for 2019 Novel Coronavirus (COVID-19) in a Healthcare Setting' section (I) Recommended Routine Infection Prevention and Control (IPC) Practices During the COVID-19 Pandemic' (B) 'Screen and Triage Everyone Entering a Healthcare Facility for signs and symptoms of COVID-19':....symptom screening remains an important strategy to identify those who could have COVID-19 .......". "Screen everyone (patients, healthcare personnel, visitors) entering the facility for symptoms consistent with COVID-19 .....". "Actively take their temperature and document absence of symptoms consistent with COVID-19". CMS-QSO-20-18-HHA (03/10/2020) 'Guidance for Infection Control and Prevention Concerning Coronavirus Disease 2019 (COVID-19) in Home Health Agencies (HHAs)' 'Guidance' states " ...... . Also, HHAs should be monitoring the health status of everyone (patients/residents/visitors/staff/etc.) in the homecare setting for signs or symptoms of COVID-19". "How should HHAs monitor or restrict home visits for health care staff? Health care providers (HCP) who have signs and symptoms of a respiratory infection should not report to work". Agency policy/procedures reviewed on November 3, 2021 at approximately 11:00 a.m. The agency policy 'Guidelines for COVID-19 Virus' 'Policy' states "The agency will implement current CDC guidelines for patients and staff who are diagnosed or suspected of having the COVID-19 virus." 'Procedure' section (8) states ....Screen all employees at the beginning of their shift for fever and respiratory symptoms. Actively take their temperature and document ........." Observation #1: On November 1, 2021 at approximately 9:00 a.m. the state surveyor arrived at the main office entry. No temperature screening nor symptom screening conducted. No COVID-19 screening log observed. Two (2) agency employees (office manager and billing department personnel) were present with no documentation of COVID-19 screening. Interview #1: On November 1, 2021 at approximately 10:30 a.m. an interview was conducted with the agency Administrator. The Administrator was asked what the agency screening protocols are for people who enter the agency office. The Administrator stated "The agency does not currently screen employees or visitors who enter the office". Interview #2: On November 1, 2021 at approximately 10:30 a.m. an interview was conducted with the agency Administrator. The Administrator was asked if agency employees in the field, who report directly to the consumers house to start their daily work shift, are self screening for COVID-19 symptoms and documenting the results. The Administrator stated "The field staff currently self screen prior to their shifts but do not document the screening process". An interview conducted with agency Administrator on November 3, 2021 at approximately 12:30 p.m. 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 an interview with the agency Administrator, agency failed to obtain a Clinical Laboratory Improvement Amendments (CLIA) Certificate or CLIA waiver for one (1) of one (1) interviews conducted (Interview #1). Findings include: Agency policy/procedures for CLIA/CLIA waiver certificates was requested on November 3, 2021 at approximately 11:00 a.m. No specific policy provided. Interview #1: On November 3, 2021 the Administrator was asked to present the agency's CLIA or CLIA waiver. Per the Adminsitrator, the agency has neither certificate. An interview conducted with agency Administrator on November 3, 2021 at approximately 12:30 p.m. confirmed the above findings.