Every finding on record at VNA of Care New England

An unannounced on-site federal complaint survey took place on 2/25/2025. Standard level deficiencies were identified as a result of this survey.

Patient's or legal representative's signature CFR(s): 484.50(a)(2) Obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities. This ELEMENT is not met as evidenced by: This element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined the Agency failed to obtain signature and maintain evidence in the clinical record to support they informed the patient of the bill of rights and provided a copy of such to the patient prior to the initiation of services, for 1 of 1 patient reviewed for confirmation of written notice of patient rights and responsibilities, Client ID #1. Findings are as follows: Review of the patient’s record revealed s/he was admitted to the Agency on 1/15/2025, for skilled services. Additional review of the clinical record failed to reveal evidence that the patient was informed of his/her rights prior to the initiation of services and provided with a written notice of patient rights and responsibilities that was signed by the patient and maintained in his/her clinical record as evidenced by the clinical record not containing such documentation. During a surveyor interview with the Director of Nursing Services on 2/25/2025 at 11:41 AM, she was unable to provide evidence that the Agency provided the patient with a written notice of patient rights and responsibilities which was reviewed with and signed by the patient prior to the initiation of services, and maintained in the clinical record, as required.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: This element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined the Agency failed to consult with and obtain a signed consent regarding planned services and care prior to the initiation of services, for 1 of 1 patient reviewed for consultation and consent to treatment, Client ID #1. Findings are as follows: Review of the patient’s record revealed s/he was admitted to the Agency on 1/15/2025 for skilled services. Further record review revealed the patient received a total of 8 visits prior to being discharged from services with the last visit conducted on 2/11/2025. Additional review of the clinical record failed to reveal evidence that the Agency consulted with the patient about care services and obtained a signature for consent to treat, prior to the initiation of services. During a surveyor interview with the Director of Nursing Services on 2/25/2025 at 11:41 AM, she acknowledged that the patient’s clinical record lacked evidence of there being a signed consent and therefore, was unable to provide evidence that the Agency consulted with and obtained consent from the patient prior to administering care and initiating services, as required.

Make efforts to resolve the problem(s) CFR(s): 484.50(d)(5)(ii) (ii) Make efforts to resolve the problem(s) presented by the patient's behavior, the behavior of other persons in the patient's home, or situation; This ELEMENT is not met as evidenced by: This element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined the Agency failed to attempt or make effort to resolve a problem presented by a patient’s behavior and failed to ensure the clinical record contained documentation of efforts taken to reduce and/or eliminate the problem (s), for 1 of 1 patient reviewed for an Agency initiated discharge, Client ID #1. Findings are as follows: Review of the patient’s clinical record revealed s/he was admitted to services on 1/15/2025 for skilled services with diagnoses including, but not limited to depression, history of suicidal ideation, and heart failure. Additional record review revealed the patient received a total of 8 home visits since his/her start of care and prior to the Agency initiating a discharge. Review of a note dated 2/11/2025, and authored by Physical Therapist, Staff A, states in part, “…PT (physical therapy) arrived during scheduled slot…Pt (patient) asleep on the couch and immediately in a foul mood…yelling…is angry…swearing about situation…depression…PT provided active listening and advised Pt not appropriate to yell at clinician…did calm down for a period of time…again started yelling when landlord entered the apartment…this pushed the Pt further yelling that things are not ok…started yelling…swearing…landlord got upset with Pt… two of them started yelling at each other…PT knew it was time to leave the home…Pt approached PT…shaking and crying…obviously more upset…PT attempted to deescalate Pt verbally with deep breathing…advised Pt that PT was leaving and would speak with the team to determine what assistance could be provided…kept swearing and crying…slammed fist down on the coffee table…PT left the home and immediately called VNA CNE…spoke with clinical manager…Staff B regarding the situation and advised he will call the pts PCP (primary care physician) to inform them of the incident and discuss discharge…” Further review of the patient’s clinical record failed to reveal documentation or evidence of any previous behaviors or incidents reported by staff and on behalf of the patient. In addition, record review failed to reveal evidence the Agency gave sufficient notice to the patient prior to discharge or made an effort to reduce or eliminate the problem before discharging the patient. During a surveyor interview with Clinical Manager/Registered Nurse, Staff B, on 2/25/2025 at 12:57 PM, he acknowledged the patient had other home visits prior to the one conducted on 2/11/2025. Staff B revealed the patient had been seen by nursing, occupational therapy and a social worker before the visit with the Physical Therapist on 2/11/2025. Staff B revealed there were no other reports of behaviors and acknowledged the behavior exhibited by the patient during the visit on 2/11/2025 was isolated in nature. In addition, Staff B was unable to provide evidence that the Agency made effort to continue to work with the patient in effort to resolve or eliminate the problem/behavior before making the decision to discharge the patient. Staff B acknowledged the last visit provided to the patient was on 2/11/2025 and therefore, was unable to provide documented evidence that is maintained in the clinical record of effort made by the Agency to try to reduce and/or eliminate the behavior/problem prior to initiating a discharge, as required.

Provide contact info other services CFR(s): 484.50(d)(5)(iii) (iii) Provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care; and This ELEMENT is not met as evidenced by: This element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined the Agency failed to provide the patient with contact information for other agencies or providers who may be able to provide care to the patient prior to initiating a discharge, for 1 of 1 patient reviewed for an Agency initiated discharge, Client ID #1. Findings are as follows: Review of the patient’s clinical record revealed the patient was admitted to skilled services on 1/15/2025. Review of the scheduled visits provided to the patient revealed s/he had visits on the following dates: -1/15/2025 -1/24/2025 -1/27/2025 -1/31/2025 -2/3/2025 -2/5/2025 -2/10/2025 -2/11/2025 Review of a note dated 2/11/2025, and authored by Physical Therapist, Staff A, who conducted a home visit on 2/11/2025 states in part, “…PT (physical therapy) arrived during scheduled slot…Pt (patient) asleep on the couch and immediately in a foul mood…yelling…is angry…swearing about situation…depression…PT provided active listening and advised Pt not appropriate to yell at clinician…did calm down for a period of time…again started yelling when landlord entered the apartment…this pushed the Pt further yelling that things are not ok…again started yelling and swearing…landlord got upset with Pt…the two of them started yelling at each other…PT knew it was time to leave the home…Pt approached PT…shaking and crying and obviously more upset…PT attempted to deescalate Pt verbally with deep breathing and advised Pt that PT was leaving and would speak with the team to determine what assistance could be provided…s/he kept swearing and crying…slammed fist down on the coffee table…PT left the home and immediately called VNA CNE…spoke with clinical manager…Staff B regarding the situation and advised he will call the pts PCP (primary care physician) to inform them of the incident and discuss discharge…” Review of a note dated 2/12/2025 and authored by Registered Nurse, Clinical Manager, Staff B states in part, “…call back…PCP office…in agreement with agency DC…” Further record review failed to reveal evidence there was serious or imminent threat of physical harm exhibited toward staff during the above-mentioned visits. The behavior as documented in the patient’s clinical record that describes the behavior exhibited by the client during the visit on 2/11/2025 included yelling, swearing, slamming his/her fist down on a table, all of which do not pose threat to staff. There was no documentation related to the patient threatening to harm the staff or attempting to do so during any visits provided by the Agency. In addition, review of the clinical record failed to contain a follow up assessment by a licensed clinician rather revealed a telephone call was made to the patient by the clinical manager who informed the patient of the Agency’s decision to discharge the patient. There was no evidence of documentation as related to the offer of help, or resources which included contact information of provider names who may have been able to provide services to the patient after being discharged from the Agency. During a surveyor interview with Clinical Manager, Registered Nurse, Staff B, on 2/25/2025 at 12:57 PM, he acknowledged the Agency initiated a discharge based on the isolated incident on 2/11/2025 in which the patient exhibited inappropriate behavior during the home visit. He further revealed that he spoke with the patient and notified him/her that his/her PCP would assist with securing services and acknowledged that he nor anyone from the Agency provided the patient with contact information or resources as related to other HHA’s (home health agencies) that could have provided him/her with services after the Agency facilitated a discharge, as required.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: This element is NOT MET as evidenced by: Based on record review and staff interview, it has been determined the Agency failed to complete a discharge summary on behalf of a facility-initiated discharge, for 1 of 1 patient reviewed for discharge summary documentation, Client ID# 1. Findings are as follows: Review of the patient’s clinical record revealed s/he was discharged from the Agency after a home visit was conducted on 2/11/2025. Further record review failed to reveal evidence the Agency completed a discharge summary that was sent to the patient’s physician within 5 days of discharge and is maintained in the clinical record containing the following: · Admission and discharge dates; · Physician responsible for the home health plan of care; · Reason for admission to home health; · Type of services provided and frequency of services; · Laboratory data; · Medications the patient is on at the time of discharge; · Patient’s discharge condition; · Patient outcomes in meeting the goals in the plan of care; and · Patient and family post-discharge instructions. During a surveyor interview with the Director of Nursing Services on 2/25/2025 at 11:41 AM, she acknowledged that the patient’s clinical record maintained by the Agency lacked evidence of a discharge summary as indicated above and required.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and staff interview it has been determined that the facility failed to maintain an emergency preparedness communication plan that includes the names and contact information for the staff. Findings are as follows: Record review of the Red Binder entitled; “Emergency Preparedness” revealed the following: A list dated November 22, 2022, titled “VNA phone list” containing the names and phone numbers of the staff from that time. A list dated August 3, 2022, titled “VNA On-Call Managers Phone list” containing the names and phone numbers of the staff from that time. During a surveyor interview on 9/18/2023 at approximately 1:30 PM with the Director of Quality Improvement she acknowledged that the list was not up to date and didn’t accurately reflect the staff that currently work at the agency.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on surveyor observation, record review and staff interview it has been determined that the home health agency failed to review all medications the patient is currently using in order to identify any potential adverse effects and drug reaction, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy for 5 of 6 patients with medications reviewed during home visits, Patient ID #s 6, 8, 9, 10 and 17. Findings are as follows: Record review of an Agency provided policy titled, “Medication Reconciliation” revealed in part, “…To develop, reconcile, and maintain an accurate patient medication list…Medication reconciliation-process of comparing the medications a patient is taking, including prescribed and over the counter medications, with newly ordered medications. The comparison addresses duplications, omissions, interactions, and the need to continue current medications…Once medication reconciliation is confirmed then clinicians shall evaluate for any new, discontinued, or changed meds at all future visits…The clinician will document in the EMR that the medication reconciliation occurred at every visit…Clinicians will update both the electronic Medication Profile and the patient’s medication list as needed when conducting the medication reconciliation process. Medications in the electronic medication profile and the patients’ medication list in the home must match…If a PTA [Physical Therapy Assistant] or COTA [ Certified Occupational Therapy Assistant] identifies a medication discrepancy, the therapy assistant will document the new, changed, discontinued medication in the EMR [Electronic Medical Record]. The next qualified clinician will follow up with the patient and physician as needed to reconcile medications and update medication list…” 1. Review of the clinical record for Patient ID # 6 revealed that s/he had a start of care date 8/30/2023 with diagnoses including but not limited to, varicose veins of left lower extremity with non-pressure chronic ulcer left lower leg. Review of Agency provided document titled, “Medication Profile” lacked the following order, Lisinopril 40mg once a day. Review of the in-home medications revealed a bottle of Lisinopril 40 mg which the patient stated s/he is taking. During surveyor observation and interview on 9/13/2023 at approximately 9:45 AM with the nurse, Staff E, in the presence of the patient's wife, she was unaware that the patient was taking the Lisinopril until brought to her attention by the surveyor, and stated she would contact the patient's physician for clarification/orders.' During interview with the Director of Quality on 9/14/2023 at approximately 11:00AM, she stated that the nurse contacted the physician, and that the Lisinopril has been added to the patient's medication profile. 2. Review of the clinical record for Patient ID # 8 revealed that s/he had a start of care date of 6/28/2023 with diagnoses including but not limited to, pressure ulcer of sacral region stage 4, pneumonia and congestive heart failure. Review of Agency provided document titled, “Medication Profile” revealed the following order for Ipratropium-albuterol mist 20mcg. During surveyor observation and interview on 9/13/2023 at approximately 1:40 PM with the client during a home visit s/he revealed the following discrepancy related to the medications that s/he is taking. The patient stated that s/he does not have the Ipratropium-albuterol mist and that s/he never had that medication. Surveyor reviewed the medication list with Staff G during the home visit and she was unaware of the Ipratropium-albuterol mist on the patient's medication profile and stated she would check with the patient’s physician to clarify the medication orders. During surveyor interview with the Manager of Clinical Education on 9/14/2023, she informed the surveyor that the nurse Staff G, contacted the physician and confirmed that the ipratropium-albuterol is not on the patient's current medication list. 3. Review of the clinical record for Patient ID # 9 revealed that s/he had a start of care date of 8/20/2023 with diagnoses including but not limited to, hypertension, COPD, 02 dependent, and diabetes. Review of Agency provided document titled, “Medication Profile” revealed the following orders meclizine 12.5 mg three times a day, sertraline ½ tab (100 mg) every day. During surveyor observation and interview on 9/14/2023 with the client & neighbor during a home visit s/he revealed the following discrepancies related to the medications that s/he is taking. The patient is not taking the meclizine and stated that the physician discontinued it, the patient is taking the whole tablet of sertraline 100mg every day, additionally the patient is taking Semaglutide 1mg/.75 injection, once a week on Mondays. During the home review of the medications with Staff B the physical therapist on 9/14/2023 she was unaware of the medication discrepancies and stated that she would clarify them. During surveyor interview with the Manager of Clinical Education on 9/15/2023 at approximately 10:35 AM, she acknowledged that the staff was unaware that the patient was receiving the Semaglutide injection weekly or taking a 100 mg of sertraline instead of the 50 mg that was on the medication list, and unaware that the meclizine was discontinued until brought to their attention by the surveyor during the home visit. 4. Review of the clinical record for Patient ID # 10 revealed that s/he had a start of care date of 7/29/2022, with diagnoses including but not limited to, hydronephrosis (excess fluid in the kidney), hydroureter (when the ureter gets bigger than normal due to a backup of urine), malignant neoplasm of the cervix uteri (cancer of the cervix), secondary malignant neoplasm of the bladder (cancer of the bladder), secondary malignant neoplasm of the retroperitoneum (space located behind the abdominal cavity) and peritoneum (membrane lining the abdominal cavity.) Review of a document provided by the agency on 9/15/2023 at approximately 8:00AM titled, “Medication Profile” revealed the following orders which the agency stated were current for the patient: -Colchicine (treat and prevent gout) 0.6mg take 1 tablet two times per day with a start date of 5/23/2023 -potassium chloride (to prevent low potassium in the body) 20 meq (milliequivalents) 1 packet 1-2 times per day with a start date of 1/3/2023 -Oxycontin (used to treat severe pain) 10 mg take 2 tablets every 12 hours with a start date of 10/17/2022 -brimonidine (eye drop for the treatment of glaucoma) 0.2% eye drops 3 drops intermittent as needed with a start date of 10/9/2022 During an observation and interview on 9/15/2023 with the client during a home visit, s/he revealed the following discrepancies related to the medications that s/he is taking: Colchicine 0.6 mg- the patient revealed that she has not been taking this medication for approximately the last 3 months. Potassium chloride 20 meq- the patient revealed that she only takes 1 packet every other day for the last couple months. Oxycontin- the patient reveled that she takes one tablet every 12 hours. Brimonidine 0.2% eye drops- the patient revealed that she has not been taking this medication for approximately 4 or 5 months. During a surveyor interview on 9/15/2023 at 12:53 PM, with Nurse Staff O, she was unable to provide evidence that she had reviewed the medications that the patient is currently taking and updated the patient’s medication list and electronic medical record as required when there are discontinued medications or changes to the patient’s orders. 5. Review of the clinical record for Patient ID # 17 revealed that s/he had a start of care date of 9/13/2023 with diagnoses including but not limited to, atherosclerotic heart disease and polyosteoarthritis. Review of Agency provided document titled, “Medication Profile” revealed the following orders Nystatin, 1 application 3 times a day. During the home review of the medications with Staff N, the social worker on 9/15/2023 she was unaware of the medication discrepancies and stated that she would clarify them. During surveyor interview with the Manager of Clinical Education on 9/15/2023 at approximately 4:05 PM, she acknowledged that the staff was unaware that the patient was not taking the Nystatin until brought to their attention by the surveyor during the home visit.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and staff interview it has been determined that the facility failed to assure communication with the physician involved in the plan of care regarding 2 of 17 patients records which were reviewed regarding missed visits, Patient ID #s 5 and 16. Findings are as follows: 1. Review of the clinical record for Patient ID # 5 revealed that s/he had a start of care date of 5/24/2023 with diagnoses including but not limited to, pressure ulcer of sacral region, stage 3 (an injury caused by pressure, which result in full thickness tissue loss), bed confinement status, gastro-esophageal reflux disease without esophagitis (inflammation of the esophagus.) Review of the patient’s record for revealed a certification period of 7/23/2023 through 9/20/2023 with a physician’s order dated 7/18/2023 for Skilled nursing 3 times per week for 9 weeks and 4 as needed visits. Review of the patient’s visits performed by a skilled nurse revealed the following: The week of 7/30/2023 through 8/5/2023, there was a missed visit on 8/5/2023. The medical record failed to reveal evidence that the physician was notified of the missed visit. The week of 8/13/2023 through 8/19/2023, there was a missed visit on 8/16/2023. The medical record failed to reveal evidence that the physician was notified of the missed visit. During a surveyor interview on 9/18/2023 at 11:59 AM with the Manager of Clinical Education, she was unable to provide evidence that the physician was notified of the above missed visits. 2. Review of the clinical record for Patient ID # 16 revealed that s/he had a start of care date of 6/2/2023 with diagnoses including but not limited to urge incontinence, Crohn's disease of large intestine without complications, ulcerative colitis, and essential hypertension. Review of the patient’s record revealed a certification period of 6/2/2023 through 7/31/2023 with a physician’s order for skilled nursing 3 times a week for 8 weeks and 4 as needed visits. Review of the patient’s visits performed by a skilled nurse revealed the following: The week of 6/18/2023 through 6/24/2023 there were two missed visits on 6/19/2023 and 6/21/2023. The medical record failed to reveal evidence that the physician was notified of the missed visits. During a surveyor interview on 9/18/2023 with the Manager of Clinical education, she was unable to provide evidence that the physician was notified of the above missed visits.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech-language pathology services, a registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in §484.80(g), must make an onsite visit to the patient's home no less frequently than every 14 days. The home health aide does not have to be present during this visit. This ELEMENT is not met as evidenced by: Based on record review and staff interview it has been determined that the Home Health Agency failed to ensure that an onsite supervisory visit conducted by a registered nurse or other appropriate skilled professional who is familiar with the patient, is completed no less than every 14 days, if home health aide services are provided to a patient who is receiving skilled nursing, physical, occupational or speech language pathology services for 1 of 3 patients reviewed who receive home health aide services, Patient ID #1. Findings are as follows: Review of the clinical record for Patient ID #1 revealed that s/he had a start of care date of 11/7/2022 with diagnoses including but not limited to, chronic obstructive pulmonary disease, dependence on supplemental oxygen, type 2 diabetes mellitus. Review of physician’s orders revealed the following Home Health Aide for personal care orders for one time per week for a total of 9 weeks: - with a begin date of 7/5/2023 and an end date of 9/2/2023. - with a begin date of 9/3/2023 and an end date of 11/1/2023. Record review of the patient’s medical record on 9/14/2023 failed to reveal evidence of onsite supervision of Home Health Aides by the skilled nurse. During a surveyor interview on 9/14/2023 at 10:52 AM with the Manger of Clinical Education she was unable to provide evidence that the Home Health Aide supervision had been completed.

Compliance with Federal, State, Local Law CFR(s): 484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients. The HHA and its staff must operate and furnish services in compliance with all applicable federal, state, and local laws and regulations related to the health and safety of patients. If state or local law provides licensing of HHAs, the HHA must be licensed. This CONDITION is not met as evidenced by: Based on record review and staff interview it has been determined that the facility failed to ensure compliance with Federal, State, and local laws and regulations related to the health and safety of patients relative to QAPI, appointment of a Director of Nursing, onsite monitoring at least every three months for 3 of 3 nursing assistants reviewed, health screenings for 2 of 2 staff who previously tested positive for tuberculosis, and failure to adhere to the general requirements of a Professional Advisory Committee (PAC). Findings are as follows: 1 Review of "Title 216- Department of Health Chapter 40- professional Licensing and Facility Regulation Subchapter 10- Facilities Regulation Part 17- Licensing Home Nursing Care Providers and Home Care Providers" states in part: "...17.5.1 Governing Body... E. Quality Improvement... 2. The organized agency-wide quality improvement program shall be ongoing and shall have a written plan of implementation. The written quality improvement plan shall include at least the following: f. Involvement of all patient care disciplines/services..." Additionally, Review of the agency ‘s policy “VNA QAPI Policy” effective date 1/23/2023 provided to the surveyor by the Director of Quality on 9/18/2023, states in part: “…It is the policy of the VNA of Care New England that the VNA QAPI committee follows the rules and regulations as set by the RI Rules and Regulations for licensing Home Nursing Care Providers and home Care Providers….” Review of the QAPI Committee Members provided to the surveyor lacks evidence of a speech language therapist (SLT) or a home health aide (HHA). During a surveyor interview with the Director of Quality on 9/18/2023 at approximately 10:30 AM, she was unable to produce evidence of involvement of all disciplines and acknowledged that the agency does not have a representative from SLT or HHA on the committee. 2. Review of "Title 216- Department of Health Chapter 40- professional Licensing and Facility Regulation Subchapter 10- Facilities Regulation Part 17- Licensing Home Nursing Care Providers and Home Care Providers" states in part: "...17.5.3 Personnel... O. Administrator and/or Director of Nursing Services... 2. In the event that a non-nurse is appointed administrator of the home nursing care provider or home care provider, the nursing service shall be under the direction of a registered nurse who is licensed in Rhode Island and who shall be responsible to the administrator for the management of professional services, the standards of practice, and other related professional aspects of patient care services..." During a surveyor interview with the Director of Quality on 9/15/2023 at approximately 2:15 PM when asked if the agency had a Director of Nurses, she stated that they have nurses who are clinical managers, but they don’t have a Director of Nurses. Review of the organizational chart provided to the surveyor revealed that agency is under the direction of the Care New England President & CEO, and the agency is listed as having a “VNA Executive Director /Interim President”. During a surveyor interview on 9/15/2023 at approximately 2:00 PM, the Director of Quality, informed the surveyor that the previous Executive Director was an RN, however the interim director who was named over a year ago is not a nurse, she is a Physical Therapist. The Director of Quality Improvement acknowledged that the agency is currently under the direction of an interim executive director who is a Physical Therapist and has not named a Director of Nurse who is responsible for the management of professional services, the standards of practice and other related professional aspects of patient care services. 3 Review of "Title 216- Department of Health Chapter 40- professional Licensing and Facility Regulation Subchapter 10- Facilities Regulation Part 17- Licensing Home Nursing Care Providers and Home Care Providers" states in part: "...17.6.5 Nursing Assistant Services... b. Monitored/supervised no less than once every three (3) months by a professional (registered) nurse or other appropriate health care professional who is licensed in Rhode Island..." Review of the on-site performance monitoring for September 2022, through September 2023, revealed the following: a. Review of the record for Staff D, an HHA who was hired on 10/10/2017 lacks evidence of any on site quarterly supervision. The record contains an annual supervision in September of 2022. b. Review of the record for Staff L, an HHA who was hired on 1/10/1994 lacks evidence of any on site quarterly supervision. The record contains an annual supervision in March of 2023. c. Review of the record for Staff M, an HHA who was hired on 3/26/2018 lacks evidence of any on site quarterly supervision. The record contains an annual supervision in March of 2023. During surveyor interview with the agencies Manager of Clinical Education, on 9/15/2023 at approximately 9:45 AM, she was unable to produce evidence that the above Home Health Aides have been supervised every three months by a professional (registered) nurse as required by regulation. She informed the surveyor that the HHA's are supervised on an annual basis, and that she was unaware that the regulation required quarterly on-site supervision of the nursing assistants in the homes. 4. The Rules and Regulations pertaining to immunization, Testing, and Health Screening for Health Care Workers (R23-17-HCW) states, in part: "...Immunization and Testing Requirements 3.5 In accordance with the guidelines set forth by the Advisory Committee on Immunization Practices (ACIP) for immunization of health care personnel, evidence of immunity is required for all health care workers (with the exception of health care workers who receive a medical exemption) against... 3.5.5 Tuberculosis (TB) (a) Pre-employment. Evidence that the health care worker is free of active tuberculosis based upon the results of a negative two-step tuberculin skin test shall be required... (4) If the PPD test or BAMT is positive, consistent with the most current Centers for Disease Control and Prevention{CDC} guidance, or a previous one is known to have been positive, a physician's or other licensed practitioner's (acting within his/her scope of practice) certification that the health care worker is free of active disease shall be required. Such certification shall be based on documentation of adequate chemotherapy for TB disease or chemo-prophylaxis for latent TB infection in the past, and a current history of freedom from signs and symptoms of TB. In the absence of documentation of chemotherapy or chemo-prophylaxis, a negative chest X-ray shall be required for certification. The chest x-ray shall have been performed at any time after the most recent positive PPD test result. (5) A physician, certified registered nurse practitioner, or a physician assistant may certify that the health care worker is currently free of TB based on his/her clinical judgment for complex cases or unusual circumstances that do not fit the above criteria..." a. Review of the immunization record for Staff D, a HHA (Home Health Aide) who has a documented date of hire listed as 10/10/2017 and has documentation of testing positive for tuberculosis. The record contains evidence of a chest x-ray however it lacks a physician clearance prior to employment. b. Review of the immunization record for Staff H, an RN (Registered Nurse) who has a documented date of hire listed as 11/3/2014 and has documentation of testing positive for tuberculosis. The record contains evidence of a chest x-ray however it lacks evidence of a physician clearance. During surveyor interview with the Director of Clinical Education on 9/14/2023 at approximately 10:15 AM, she was unable to produce evidence that the above staff, who had tested positive for TB, had a physician clearance to work based on a negative chest x-ray and examination as required. 5. Review of "Title 216- Department of Health Chapter 40- professional Licensing and Facility Regulation Subchapter 10- Facilities Regulation Part 17- Licensing Home Nursing Care Providers and Home Care Providers" states in part: "...17.8.2 Governing Body & Management Professional Advisory Committee A. An advisory group of professional personnel ("Professional Advisory Committee") shall be established by the governing body or other legal authority..." During review of the agencies Quality Improvement records, there lacked evidence of a Professional Advisory Committee. Review of the agencies Quality Improvement (QI) program with the Director of Quality Improvement on 9/18/2023 at approximately 11:30 AM, she stated that the agency no longer had a PAC committee. She informed the surveyor that the agency had a committee in 2016 however it has been combined with the Quality Improvement committee.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and staff interview it was determined that the Home Health Agency failed to ensure that the clinical record was complete and accurate for 3 of 4 sample patients reviewed for pressure ulcers, Patient ID #s 3, 4 and 5. Findings are as follows: Review of a facility policy titled, “PROCESS: Use of the Wound Addendum” revealed in part, “…The purpose of this process is to establish a procedure and process for use of the Wound Addendum and establish a standard format for assessment and treatment of wounds…The clinician will document all wound characteristics by completing each section of the Wound Addendum at each visit…Open wounds will be measured weekly on the first of the week, or a subsequent visit if that was not possible…” 1. Review of the clinical record for Patient ID #3 revealed that s/he had a start of care date of 6/22/2023 with diagnoses including but not limited to, pressure ulcer of the sacral region, stage 2. A physician’s order for the certification period of 8/21/2023 through 10/19/2023 revealed an order for the skilled nurse to perform wound care to the stage 2 coccyx pressure ulcer two times weekly and as needed for saturation. Review of the wound documentation in the patient’s record revealed missing documentation for weekly wound measurements between the dates of 8/20/2023 through 8/26/2023. A partial assessment was completed on 8/22/2023 revealing that there was greater than 25% granulation (a type of new connective tissue) and greater than 25% epithelial (tissue that forms the outer covering of skin.) There failed to be documentation of wound measurements. During a surveyor interview on 9/18/2023 at 10:15 AM with the wound care coordinator Staff J, she was unable to provide evidence that the above weekly wound measurements were obtained. 2. Review of the clinical record for Patient ID #4 revealed that s/he had a start of care date of 8/6/2020 with diagnoses including but not limited to, pressure ulcer of the left gluteus Medius (buttock), stage 4. A physician’s order for the certification period of 7/22/2023 through 9/19/2023 revealed an order for the skilled nurse to perform wound care to the stage 4 ulcer 3 times weekly. Further record review revealed a stage 2 pressure ulcer to the Right ischium (lower back part of the hip bone) with an onset date of 7/24/2023. A physician’s order for the certification period of 7/22/2023 through 9/19/2023 revealed an order for the skilled nurse to perform wound care to the stage 2 ulcer 3 times weekly. Review of the wound documentation in the patient’s record revealed missing documentation for weekly wound measurement for the above wounds for the weeks of 8/13/2023 through 8/19/2023 and 8/20/2023 through 8/26/2023. During a surveyor interview on 9/18/2023 at 12:08 PM with the Manager of Clinical Education, she was unable to provide evidence that the above weekly wound measurements were obtained. 3. Review of the clinical record for Patient ID #5 revealed that s/he had a start of care date of 5/24/2023 with diagnoses including but not limited to, pressure ulcer of the sacral region, stage 3. A physician’s order for the certification period of 7/23/2023 through 9/20/2023 revealed an order for the skilled nurse to perform wound care to the stage 3 ulcer 3 times weekly. Review of the wound documentation in the patient’s record revealed missing documentation for weekly wound measurement for the above wounds for the weeks of 8/20/2023 through 8/26/2023 and 9/3/2023 through 9/9/2023. During a surveyor interview on 9/18/2023 at 12:03 PM with the Manager of Clinical Education, she was unable to provide evidence that the above weekly wound measurements were obtained.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and staff interview it has been determined that the agency failed to complete discharge summaries for 2 of 4 patient whose closed records were reviewed, patient ID #’s 11 & 16. Findings are as follows: 1. Review of the record for patient ID # 11 reveals the patient was admitted to the home care agency, with a start of care date of 7/24/2023 and discharged on 8/21/2023. Review of the record lacks evidence of a discharge summary. 2. Review of the record for patient ID # 16 reveals the patient was admitted to the home care agency, with a start of care date of 6/2/2023 and a discharge date 6/14/2023 on the agencies discharge list. Review of the record lacks evidence of a discharge summary. During surveyor interview with the Nurse Educator and Clinical Nurse Manager on 9/18/2023, they were unable to produce evidence of discharge summaries for patient ‘s ID # 11 and 16.