Every finding on record at Penn Medicine Home Health Princeton Health

This is a Federal Recertification Survey that was conducted on May 26, 2021 to May 28, 2021. Penn Medicine Princeton Home Health is in compliance with 42 CFR Part 484 Emergency Preparedness 484.102: Condition of Participation for Home Health Agencies. No deficiencies were identified.

This is a Federal Recertification Survey and a State Relicensure Survey conducted on May 26, 2021 to May 28, 2021. Penn Medicine Princeton Home Health is not in compliance with N.J.A.C. Title 8 Chapter 42 - Licensing Standards for Home Health Agencies and Penn Medicine Princeton Home Health is not in compliance with 42 CFR Part 484 regulations for Home Health Agencies. Condition level and Standard level deficiencies were identified. The following Conditions were determined to be out of compliance: 484.65: Quality Assessment and Performance Improvement 484.70: Infection Prevention and Control A Focused Infection Control Audit was conducted on May 26, 2021 to May 28, 2021, deficiencies were identified.

Revisions communicated to patient and MDs CFR(s): 484.60(c)(3)(i) (i) Any revision to the plan of care due to a change in patient health status must be communicated to the patient, representative (if any), caregiver, and all physicians or allowed practitioner's issuing orders for the HHA plan of care. This ELEMENT is not met as evidenced by: Based on staff interview, medical record review, and review of facility policy and procedure, it was determined that the facility failed to ensure that the physician was notified of missed therapy visits in three (3) out of thirteen (13) medical records reviewed. Findings include: Reference: Facility policy titled "Patient Notification of Changes in the Plan of Care" states: "... PROCEDURE ... 2. ... d. When it is anticipated that a visit cannot be made because of unforeseen circumstances or at a patient request, personnel will immediately notify the physician, team manager and/or patient. The clinician will document that the physician was notified in the clinical record ....." 1. On 5/27/2021, the medical record of Patient #6 was reviewed and an order for physical therapy was identified that noted visit frequency as: "5/4/2021 to 7/2/2021 for 2 -3 visits per week for 9 weeks" in addition to an order for the week of 5/4/2021: "1 visit per week for 1 week evaluation and treat." a. For the week of 5/4/2021, the medical record revealed that the physical therapist saw the patient for an evaluation on 5/6/2021, and had a missed visit on 5/7/2021. The medical record contained a note written by Staff #17, a physical therapist, dated 5/7/2021 stating that the patient canceled the visit. The medical record lacked evidence that Staff #17 notified the physician of the missed visit. b. For the week of 5/9/2021, the medical record revealed that there was a missed physical therapy visit on 5/14/2021. The medical record contained a note written by Staff #17, dated 5/14/2021, stating that the patient canceled the visit because [the patient] was feeling sleepy. The medical record lacked evidence that Staff #17 notified the physician of the missed visit. c. For the week of 5/16/2021, the medical record revealed that there was a missed physical therapy visit on 5/19/2021. The medical record contained a note written by Staff #18, a physical therapist, dated 5/19/2021 stating that the patient was not feeling well and did not have the energy to do therapy. The medical record lacked evidence that Staff #18 notified the physician of the missed visit. 2. On 5/27/2021, the medical record of Patient #7 was reviewed and an order for physical therapy was identified that noted visit frequency as: "5/6/2021 to 7/3/2021 for 2-3 visits per week for 9 weeks." For the week of 5/9/2021, the medical record revealed that there was a missed visit on 5/13/2021. The medical record contained a note written by Staff #19, a physical therapist, dated 5/13/2021, stating that the patient canceled the scheduled physical therapy visit and would reschedule for the following week on 5/17/2021. The medical record lacked evidence that Staff #19 notified the physician of the missed visit. 3. On 5/27/21, the Medical Record of Patient #12 was reviewed and an order for Skilled Nurse was identified that noted visit frequency as: "1/9/2021 to 3/6/2021: 1 to 2 visits every week for 9 weeks." a. During the week of 1/17/21 - 1/23/21, Patient #12 did not receive a Skilled Nurse visit. b. There was no evidence in the medical record that any Skilled Nurse Visits were scheduled or completed. c There was no documentation in the medical record that the physician was notified of the missed Skilled Nurse visits. 4. The above findings were confirmed by Staff #11 and Staff #12 at 1:54 PM. NJAC 8:42-6.2(a)(2) NJAC 8:42-6.2(a)(3)

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 staff interview and document review, it was determined that the facility failed to ensure the evaluation and maintenance of their Quality Assessment and Performance Improvement (QAPI) program. Findings include: 1. The facility failed to ensure that the home health agency selects the indicators that will be utilized in its Quality Assurance Performance Improvement (QAPI) program. (Refer to Tag G-0642). 2. The facility failed to ensure that the effectiveness of the facility's QAPI program was monitored. (Refer to tag G-0644). 3. The facility failed to ensure that performance improvement preventative measures were implemented as a result of adverse events. (Refer to tag G-0654)

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 staff interview, the facility failed to ensure that the home health agency selects the indicators that will be utilized in its Quality Assurance Performance Improvement (QAPI) program. Findings include: 1. An interview on 5/27/2021 at 1:05 PM with Staff #3, a QAPI manager, identified the following: (a) The home health agency coordinates with a parent company that incorporates home health, hospice, and caregivers within it's "umbrella." Staff #3 identified that the parent company/group determines the indicators that will be measured yearly for the home health agency and the hospice agency. (b) Staff #3 stated that he/she monitors the adverse events at the facility and provides feedback to staff involved via email or at staff meetings if the adverse event is different than any of the current metrics that are assigned by the parent company to be monitored by the facility. 2. On 5/28/2021 at 10:06 AM, an interview with Staff #3 confirmed that although the feedback is provided to staff, there is a lack of follow-up to determine if the feedback provided resulted in changes in the provision of care or in an improvement of outcomes. Staff #3 confirmed that these indicators are not measured due to the lack of follow-up. 3. Upon request to Staff #3 on 5/28/2021 at 10:06 AM, the facility was unable to provide evidence of a quality indicator that was chosen by the home health QAPI team based on specific identified issues occurring within the home health agency. 4. Upon request to Staff #3 on 5/28/2021 at 10:06 AM, the facility was unable to provide evidence of how the current metrics were chosen by the parent company to be monitored by the home health agency. NJAC 8:42-14.2(b) NJAC 8:42-14.2(c)

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 staff interview and the review of pertinent facility documentation, it was determined that the facility failed to ensure that the effectiveness of the facility's quality assurance performance improvement (QAPI) program is monitored. Findings include: 1. On 5/27/2021 at 1:05 PM, upon request to Staff #3, a QAPI manager, the facility's QAPI program was provided. It was identified that the facility's number of reported falls had a significant increase between the years 2019 and 2020. An interview with Staff #3 identified that the number of falls that were reported increased due to a newly implemented reporting system that was easier for clinicians to use. Staff #3 stated that education of this system was provided to clinicians and encouraged clinicians to report all levels of incidents from minor/no injury to major with injury. 2. The monitoring of the incident reporting system to determine if the clinicians were using the system correctly was requested of Staff #3 on 5/28/2021 at 9:54 AM. The facility was unable to provide the auditing and monitoring as requested. When asked how the facility was determining the education to clinicians was effective, Staff #3 stated: "I don't know." 3. On 5/27/2021 at 1:05 PM, an interview with Staff #3 was conducted and he/she stated that he/she monitors adverse events at the facility and provides feedback to staff involved via email or at staff meetings if the adverse event is different than any of the current metrics that are being monitored by the facility. On 5/28/2021 at 10:06 AM, an interview with Staff #3 confirmed the previous statement and also noted that although the feedback is provided to staff, there is a lack of follow-up and monitoring to determine if the feedback provided to staff resulted changes in the provision of care or in an improvement of patient outcomes. NJAC 8:42-14.2(c) NJAC 8:42-14.2(d)(5)

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 staff interview, it was determined that the facility failed to ensure that performance improvement preventative measures are implemented as a result of adverse events. Findings include: 1. On 5/28/2021 at 9:54 AM, an interview was conducted with Staff #3, a quality assurance performance improvement (QAPI) manager, and the following was identified: (a) Staff #3 stated that he/she monitors adverse events at the facility and provides feedback to staff involved via email or at staff meetings if the adverse event is different than any of the current metrics that are being monitored by the facility. (b) Staff #3 confirmed that there is no additional monitoring to ensure if preventative measures were implemented and that there is no additional follow-up with the staff to determine if changes were made to prevent the incident from reoccurring. 2. Upon request on 5/28/2021 at 9:54 AM, Staff #3 was unable to provide evidence of feedback given to agency staff regarding an adverse event. NJAC 8:42-14.2(d)(1)

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on staff interview, observation, medical record review, and review of facility policy and procedure, it was determined that the facility failed to ensure the maintenance of an infection control program. Findings include: 1. The facility failed to ensure that contact precautions are maintained in accordance with acceptable standards of practice. (Refer to tag G-0682). 2. The facility failed to ensure a barrier was maintained to limit contamination in a patient care area. (Refer to tag G-0682). 3. The facility failed to ensure that a qualified person is designated for infection prevention and control responsibilities. (Refer to Tag G-0684). 4. The facility failed to ensure an accurate COVID-19 patient screening prior to the scheduled visit. (Refer to Tag G-0684). 5. The facility failed to ensure that visitors entering the agency's office were screened for COVID-19. (Refer to Tag G-0684).

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: A. Based on review of CDC (Centers for Disease Control) Guidelines, observation of one (1) of five (5) home visits, medical record review, and review of facility policy and procedure, it was determined that the facility failed to ensure that contact precautions are maintained in accordance with acceptable standards of practice. Findings include: Reference #1: Centers for Disease Control (CDC) 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Setting (http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf) states, "[page 72] Contact Precautions also apply where the presence of excessive wound drainage, fecal incontinence, or other discharges from the body suggest an increased potential for extensive environmental contamination and risk of transmission. ...Healthcare personnel caring for patients on Contact Precautions wear a gown and gloves for all interactions that may involve contact with the patient or potentially contaminated areas in the patient's environment. ...[page 88] Limit the amount of non-disposable patient-care equipment brought into the home of patients on Contact Precautions. Whenever possible, leave patient-care equipment in the home until discharge from home care services. ..." Reference #2: Facility policy titled, "Contact Precautions" states, " ...Diseases Requiring Contact Precautions ...MRSA (Methicillin-resistant Staphylococcus Aureus) infection ... Procedure for Patients Residing in the Community A. Precautions for Health Care Personnel 1. ...a. Gowns and gloves should be worn for procedures and patient care activities likely to generate splashes or sprays of body fluids. ... 4. If possible, a disposable stethoscope and blood pressure cuff should be dedicated to use on a single patient. ..." 1. On 5/26/2021, during a home visit for Patient #3, the following was observed: a. At 1:27 PM, Staff #9, a Registered Nurse (RN), removed a blood pressure cuff and stethoscope from his/her bag and checked the patient's blood pressure. Staff #9 used alcohol wipes to clean the blood pressure cuff and stethoscope, then placed them back into his/her bag. A disposable stethoscope and blood pressure cuff was not used. b. At 1:40 PM, Staff #9 performed a dressing change for a right buttock wound treated with Negative Pressure Wound Therapy. Staff #9 did not don a gown while providing any patient care, including the dressing change on the right buttock wound. 2. On 5/27/2021 at 1:15 PM, a review of Medical Record #3 contained the following documentation in the patient's Plan of Care: "Infection Control Precautions...Contact Precautions...[Each visit, Start 5/22/21] [Contact Precautions for MRSA (Methicillin-resistant Staphylococcus aureus) infection]." a. Upon interview, Staff #12, a manager, revealed that when patients are on isolation precautions, the staff providing home care services have available for use "specific kits with PPE (personal protective equipment)" which include a "gown, disposable stethoscope, disposable blood pressure cuff ..." b. On 5/28/2021 at 10:00 AM, Staff #2, an administrator, confirmed the RN should be following the "Plan of Care" for the patient, including Contact Precaution orders. 3. The above findings were confirmed with Staff #1, Staff #2, and Staff #12 at 12:35 PM. B. Based on observation of one (1) of five (5) home visits, staff interview, and review of Centers for Disease Control (CDC) guidelines, it was determined that the facility failed to ensure a barrier is maintained to limit contamination in a patient care area. Findings include: Reference: CDC 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf), page 50 states, "During patient care, transmission of infectious organisms can be reduced by adhering to the principles of working from 'clean' to 'dirty', and confining or limiting contamination to surfaces that are directly needed for patient care." 1. On 5/26/2021 at 1:35 PM, during a home visit for Patient #3, Staff #9, a registered nurse (RN), was observed performing a dressing change on the patient's right buttock. Staff #9 set up two blue pads side by side on the patient's couch, next to the patient, and placed clean supplies on the pads. a. Staff #9 removed a bottle of Curad cleanser from a bag of supplies located on the patient's couch, opened the bottle, and applied the contents to a gauze pad. The bottle of Curad was placed on the blue pad farthest from the patient. Staff #9 used the gauze pad to clean the patient's wound. b. At 1:50 PM, after Staff #9 replaced the dressing on the patient's right buttock, he/she wrapped up the dirty supplies in the blue pad closest to the patient, and disposed of the bundle in the garbage can. The bottle of Curad cleanser fell off the remaining pad and onto the patient's couch, with the cap off, and the nozzle where the contents are released laying against the seat of the couch. c. At 1:55 PM, Staff #9 replaced the cap on the bottle of Curad cleanser and placed it in the patient's bag of supplies. 2. The above findings were confirmed with Staff #1, Staff #2, and Staff #12 at 12:35 PM. C. Based on observation of two (2) of five (5) home visits, review of facility policy and procedure, and review of CDC (Centers for Disease Control) guidelines, it was determined that the facility failed to ensure that alcohol-based hand rub is allowed to dry when decontaminating hands. Findings Include: Reference: Guidelines for Hand Hygiene in Health Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee [HICPAC] and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force, published in the CDC (Centers for Disease Control and Prevention) Morbidity and Mortality Weekly Report at MMWR 2002; 51 (No. RR-16) page 32 states, "... Recommendations ... 2. Hand-hygiene technique A. When decontaminating hands with an alcohol-based hand rub, apply product to palm of one hand and rub hands together, covering all surfaces of hands and fingers, until hands are dry ... ." 1. On 5/26/2021, during a home visit for Patient #3, the following was observed: a. At 1:33 PM, Staff #9, an RN, applied hand sanitizer and immediately reached inside his/her bag to retrieve a pack of alcohol wipes with hands visibly wet. b. At 1:40 PM, Staff #9 removed his/her gloves, applied hand sanitizer, and immediately donned gloves with hands visibly wet. c. At 1:46 PM, Staff #9 removed his/her gloves, applied hand sanitizer, and immediately donned gloves with hands visibly wet. Staff #9 stated, "It makes it difficult after hand sanitizer to put on gloves." 2. On 5/27/2021, during a home visit for Patient #4, the following was observed: a. At 9:35 AM, Staff #13, an RN, applied hand sanitizer and immediately donned gloves with hands visibly wet. b. At 9:52 AM, Staff #13 applied hand sanitizer and immediately opened a Sterile Dressing Kit with hands visibly wet. Staff #13 then reapplied hand sanitizer and immediately donned sterile gloves with hands visibly wet. 3. The above findings were confirmed with Staff #1 and Staff #2, both administrators, on 5/28/2021 upon exit conference. NJAC 8:42-12.2(b)(1) NJAC 8:42-12.2(b)(3) NJAC 8:42-12.2(b)(6)(i) NJAC 8:42-12.2(b)(6)(ii)

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: A. Based on staff interview and review of facility personnel files, it was determined that the facility failed to ensure that a qualified person is designated for infection prevention and control responsibilities. Findings include: 1. On 5/26/2021, upon entrance, Staff #1, Director of Home Health, identified Staff #6 as the facility's designated Infection Control person. 2. Upon interview with Staff #6 on 5/27/2021 at 2:20 PM, Staff #6 stated that he/she was not aware that he/she was the day to day infection control professional at the home health agency and when he/she was told that Staff #1 had identified him/her in that role, Staff #6 asked: "What does that mean?" 3. On 5/28/2021 at 11:51 AM, upon review of the personnel file for Staff #6, the signed Job Description did not include a designation of the infection control role. Staff #6's personnel file did not contain any additional education or training for the infection control role. 4. The above findings were confirmed with Staff #1 on 5/28/2021 at 11:55 AM. B. Based on staff interview, medical record review, and review of facility policy and procedure, it was determined that the facility failed to ensure an accurate COVID-19 patient screening prior to the scheduled visit in one (1) out of thirteen (13) medical records reviewed. Findings include: Reference #1: Facility policy titled, "FY [Fiscal Year] 2021 Infection Control Plan" states: "...OBJECTIVES 1. To establish the mechanism by which staff will address surveillance, prevention, identification, and control of infections..... Risk Priorities Minimize risk of COVID-19 infection to staff, patients, and families... Strategies to Achieve Goal ... -Standardize screening for COVID-19 on all patients who come onto the [facility] services ....." Reference #2: Facility screening protocol titled, "Coronavirus Screening (updated version)" states: "Please ask the following when scheduling all patients: 1- Within the last 14 days, have you or anyone in your home had contact with a confirmed or suspected Coronavirus infection, including anyone who has had a coronavirus swab screening? If yes, escalate to a manager prior to scheduling 2-In the past 72hrs (hours) have you or anyone in your home had cough, shortness of breath, fever, chills, muscle pain, new loss of taste or smell, headache, congestion, runny nose, vomiting and/or diarrhea? if yes, escalate to a manager prior to scheduling ... ." 1. On 5/27/2021, the medical record of Patient #6 was reviewed and the following was identified: a. A visit note written by Staff #18, a physical therapist, on 5/19/2021 stated, "...Patient reported not feeling good, threw up few times and don't have any energy to do therapy....." b. On 5/20/2021, a visit note was entered by Staff #18, that included a Coronavirus Screening. The Screening indicated that the patient had not had a cough, shortness of breath, fever, chills, muscle pain, new loss of taste or smell, headache, congestion, runny nose, vomiting and/or diarrhea in the past 72 hours. 2. Staff #11, an administrator, confirmed the above findings at the time of discovery and stated that the Coronavirus Screening of the patient completed on 5/20/2021 was incorrect. 3. Upon request to Staff #1, an administrator, and Staff #11, the facility was unable to provide evidence that the patient's symptoms were escalated to a supervisor per protocol by Staff #18. C. Based on observation, staff interview, and review of facility protocols, it was determined that the facility failed to ensure that visitors entering the home health agency's office are screened for COVID-19. Findings include: Reference: Facility policy titled "Infection Control Plan" states: "... OBJECTIVES a. To establish the mechanism by which staff will address surveillance, prevention, identification, and control of infections....." 1. On 5/26/2021 at 9:19 AM, four (4) surveyors entered the office of the home health agency and were greeted by Staff #1. The surveyors were then escorted to a conference room. None of the four (4) surveyors were screened for COVID-19 symptoms. 2. On 5/27/2021 at 11:09 AM, a conversation with Staff #2, an administrator, confirmed that there was a lack of screening of visitors to the home health agency offices for COVID-19. a. Staff #2 stated that the screening should have been completed by a staff member at the front desk, but the staff member had vacated his/her position over a week ago. b. Staff #2 stated that there is no one filling the front desk position and that the COVID-19 screening should have been delegated to another staff member. 3. On 5/27/2021 at 2:20 PM, an interview was conducted with Staff #6, a professional development specialist, who was identified as being the day to day infection control professional. Staff #6 confirmed that visitor screening should have been completed by a staff member at the front desk, but that there is no one currently in that position. Staff #6 also confirmed that the task of screening visitors should have been delegated to another staff member, but had not. NJAC 8:42-12.1(b) NJAC 8:42-12.2(b)(5)