Lehigh Valley Home Care Hazleton

“EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: Based on a review of the agency policies/procedures and documentation and based on interview with the administrator (Employee #12), the agency failed to ensure emergency preparedness exercises were conducted for one (1) of three (3) years beginning in 2022. (2023) Findings Include: On July 31, 2024 at approximately 1:47 PM, review of the “Emergency Preparedness Plan-Home Health Services” revealed the following: Disclaimer: This policy and the implementing procedures are intended to provide a description of recommended courses of action to comply with statutory or regulatory requirements... Recovery and Evaluation...4. Lehigh Valley Home Health Services will test the Emergency Management Plan at least twice annually, either in response to an actual emergency or planned exercise. On July 31, 2024 at approximately 1:47 PM, review of the emergency preparedness binder failed to reveal that emergency preparedness exercises (full-scale community-based, facility-based functional, mock disaster drill or tabletop exercise) had been conducted in 2023. During interview conducted on July 31, 2024 at approximately 3:10 PM, the administrator confirmed emergency preparedness exercises were not conducted in 2023.”

“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 the review of agency policies/procedures and clinical records, and based on interview with the Clinical Manager (Employee #10) and the Administrator (Employee #12), the agency failed to ensure the “Home Health Certification and Plan of Care” included orders for the volume of normal saline solution (NSS) to be administered after a blood (laboratory) sample was obtained from a peripherally inserted central catheter (PICC-intravenous line which is inserted into a vein in the arm.) for two (2) of two (2) patients for whom PICC line was present at recertification. (Patients #6 and #10) Findings include: On August 2, 2024 at approximately 3:19 PM, review of the agency policy titled “Plan of Treatment-Home Health Services” revealed the following: I. Policy...There must be a Plan of Treatment that health team members follow to provide the necessary patient care in a regulated manner... III. Procedure....3. The Plan of Treatment...must include, but is not limited to...k. Medications...m. Treatments...q. Other appropriate items. Patient #6: Between August 1, 2024 at approximately 2:18 PM and August 2, 2024 at approximately 12:12 PM, review of the clinical record revealed the “Home Health Certification and Plan of Care” for the recertification period of 06/03/2024 through 08/01/2024 included the following skilled nursing (SN) orders: May draw labs from the PICC line as ordered by the physician. Review of SN visit documentation revealed the PICC line was flushed with 20 cc (cubic centimeters) of NSS after the blood samples were obtained from the PICC line on 06/03, 06/6, 06/24, 07/01, 07/04, 07/08, 07/11, 07/18, 07/22, 07/25, 07/29 and 08/01/2024. There was no documentation on the “Home Health Certification and Plan of Care” which provided evidence orders were obtained for the volume of NSS to be administered after a blood sample was obtained from the PICC. Patient #10: On August 2, 2024 at approximately 11:15 AM, review of the clinical record revealed the “Home Health Certification and Plan of Care” for the recertification period of 06/25/2024 though 08/23/2024 included the following skilled nursing (SN) orders: Obtain blood work as ordered and perform PICC line dressing changes weekly and as needed. Review of SN visit documentation revealed the PICC line was flushed with 20 cc of NSS after the blood samples were obtained from the PICC line on 07/03, 07/08, 07/11, 7/15, 07/22, 07/29 and 07/30/2024. There was no documentation on the “Home Health Certification and Plan of Care” which provided evidence orders were obtained for the volume of NSS to be administered after a blood sample was obtained from the PICC. During interview conducted on August 2, 2024 at approximately 3:25 PM, the Administrator and Clinical Manager confirmed there was no documentation on the “Home Health Certification and Plan of Care” which provided evidence orders were obtained for the volume of NSS to be administered after a blood sample was obtained from the PICC for the above identified patients.”

“Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This Element is not met as evidenced by: Based on the review of agency procedures and clinical records, and based on interview with the Director of Quality for Home Health (DOQ-Employee #11), the Clinical Manager (Employee #10) and the Administrator (Employee #12), the agency failed to ensure assessment of the peripherally inserted central catheter (PICC-intravenous line which is inserted into a vein in the arm) was completed in by the registered nurse (RN) in accordance with agency procedures for two (2) of two (2) patients for whom PICC line was present at recertification. (Patients #6 and #10) Findings include: On August 2, 2024 at approximately 1:08 PM, review of the agency PICC assessment procedure revealed the following: Assessment and Preparation...b. Check the catheter for migration. Observe the external length and compare to the insertion record. Monitoring and Care...6. Observe for signs of catheter dislodgement or migration. During interview conducted on August 2, 2024 at approximately 1:10 PM, the DOQ reported external PICC length measurements should be obtained every visit. Patient #6: Between August 1, 2024 at approximately 2:18 PM and August 2, 2024 at approximately 12:12 PM, review of the clinical record revealed the “Home Health Certification and Plan of Care” for the recertification period of 06/03/2024 through 08/01/2024 included the following skilled nursing (SN) orders under “Visit Sets”: SN for...observation, assessment...related to altered infusion therapy status... Review of SN visit documentation failed to reveal the external length of the PICC had been assessed by the RN (Employee #7) on 07/11/2024. Patient #10: On August 2, 2024 at approximately 11:15 AM, review of the clinical record revealed the “Home Health Certification and Plan of Care” for the recertification period of 06/25/2024 through 08/25/2024 included the following SN orders under “Skilled Nursing”: SN to provide observation/assessment... Review of SN visit documentation failed to reveal the external length of the PICC had been assessed by the assigned RN (Employees #13, #14 or #15) on 06/27, 07/01, 07/03, 07/08, 07/11, 07/15, 07/18, 07/22, 07/25 nor 07/29/2024. During interview conducted on August 2, 2024 at approximately 3:25 PM, the Administrator, Clinical Manager and DOQ confirmed there was no documentation which provided evidence the above referenced RNs assessed the external length of the PICC on the forementioned dates for the above identified patients.”

“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 the review of agency policies/procedures, clinical records and personnel files, and based on interview with the Clinical Manager (Employee #10) and the Administrator (Employee #12), the agency failed to ensure documentation was maintained in the personnel file which provided evidence three (3) of six (6) registered nurses (RN) completed a demonstration to determine competency to provide/perform maintenance/care of and obtain blood samples from a peripherally inserted central catheter (PICC-intravenous line which is inserted into a vein in the arm.) or to provide maintenance/care for a tracheostomy (surgically created airway located in the front of the neck). (Employees #2, #4 and #8) Findings include: On August 2, 2024 at approximately 3:17 PM, review of the agency policy titled “Competence Assessment-Human Resources” revealed the following: I. Policy: The competence of employees is continuously assessed, demonstrated, maintained and documented throughout the employee’s association with Lehigh Valley Health Network, from orientation to termination... III. Procedure...B. Each competency will be assessed utilizing one of more of the following methods...direct observation of skill/performance...return demonstration or simulation... Patient #1: Between July 30, 2024 at approximately 2:43 PM and August 2, 2024 at approximately 11:45 AM, review of the clinical record revealed the RN (Employee #8) provided tracheostomy care (dressing change) during the skilled nursing (SN) visits performed on 07/03, 07/09, 07/18 and 07/23/2024. Patient #6: Between August 1, 2024 at approximately 2:18 PM and August 2, 2024 at approximately 12:12 PM, review of the clinical record revealed the following RNs provided PICC line care and/or obtained blood specimens from the PICC line during the SN visits performed on the below listed dates: Employee #2: 07/18, 07/25, 07/29 and 08/01/2024; and Employee #4: 06/20/2024. Between August 2, 2024 at approximately 9:40 AM and 2:42 PM, review of personnel file documentation revealed the following: Employee #2: The date of hire of the RN was 10/08/1990 with the transfer date to home health being 09/01/1997. There was no documentation in the personnel file which provided evidence the RN completed a competency evaluation/demonstration to provide PICC line maintenance/care nor to obtain blood specimens from a PICC line. Employee #4: The date of hire of the RN was 11/02/2009. There was no documentation in the personnel file which provided evidence the RN completed a competency evaluation/demonstration to provide PICC line maintenance/care nor to obtain blood specimens from a PICC line. Employee #8: The date of hire of the RN was 11/15/2019 with the transfer date to home health being 02/20/2022. There was no documentation in the personnel file which provided evidence the RN completed a competency evaluation/demonstration to provide tracheostomy care. During interview conducted on August 2, 2024 at approximately 2:42 PM, the Clinical Manager reported competency evaluations for the above referenced procedures for Employees #2, #4 and #8 were completed but the hard copy (paper) of the competency evaluations could not be located. During interview conducted on August 2, 2024 at approximately 3:25 PM, the Administrator and Clinical Manager confirmed there was no documentation in the personnel files which provided evidence that the above referenced RNs had completed a competency demonstration to provide/perform maintenance/care of and/or obtain blood samples from a PICC line or to provide maintenance/care for a tracheostomy.”