Maxim Healthcare Services, Inc.

“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 record review and staff interview, it has been determined that the agency failed to maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases relative to the use of a staff members personal glucometer to monitor a patient’s blood glucose levels, and the disposal of the soiled lancet devices used for blood glucose monitoring for 1 of 2 diabetic patients reviewed, Patient ID #1. Findings are as follows: Review of the agency reported complaint submitted to the Rhode Island Department of Health on 9/27/2024, revealed that on 9/26/2024 Licensed Practical Nurse (LPN), Staff A reported to the Clinical Manager Registered Nurse (RN), Staff B that a used lancet (used to obtain blood for testing blood sugar, or glucose levels) was found in the glucometer (blood glucose monitoring device) for Patient ID #1. Review of the agency policy titled, “Infection Control Program”, revised on 4/16/2021, states in part, “…Control of an infection or an infectious disease outbreak includes: ...Implementing appropriate nursing practices to limit the transmission of the infection…” Review of the agency policy titled, “Medical Waste Handling and Disposal”, revised on 7/10/2020, states in part, “…Medical waste materials will be handled…in accordance with standard precautions and all applicable laws and regulations…Contaminated needles and other contaminated sharps shall not be bent or recapped and immediately or as soon as possible after use, placed in a sharps container…” Review of the record for Patient ID #1 revealed s/he was admitted to the home care agency with diagnoses including but are not limited to hypoxia or hypercapnia (respiratory conditions that can cause shortness of breath), type 1 diabetes mellitus, epilepsy, reduction deformities of the brain, tracheostomy (an opening surgically created through the neck into the windpipe to allow air to fill the lungs), and gastrostomy (an opening into the stomach from the abdominal wall, made surgically for the introduction of food). Review of the care plan revealed a physician’s order to test his/her blood sugar every four hours. Review of an agency document titled, “Grievance Documentation” revealed that on 7/20/2023 LPN, Staff A expressed concern that RN, Staff C, was not disposing of a used lancet properly noting this is a safety hazard. Registered Nurse, Staff C was interviewed by the agency and acknowledged leaving a used lancet in the chamber. Further review revealed that Staff A indicated that this is the fifth time that RN, Staff C, had left a used lancet in the work area. Review of two documents, dated 4/11/2024, titled, “Corrective Action Form” and “Incident Report: Interview Summary” revealed that on 4/10/2024 LPN, Staff A reported to Clinical Supervisor, Staff D that a dirty lancet was left in the in the patient’s bed by RN, Staff C after obtaining his/her blood sugar around 6:00 AM. LPN, Staff A had indicated that she found the lancet in his/her bed after arriving for her 9:00 AM shift. Review of two documents, dated 9/27/2024 and titled, “Corrective Action Form” and “Incident Report”: Interview Summary” revealed that on 9/26/2024 LPN, Staff A reported to the Clinical Manager RN, Staff B that RN, Staff C left a dirty lancet in the patient’s glucose device and indicated that this is the 5th time she had found a dirty lancet in the work area. Additional review of these documents revealed that a final warning was given to Staff C relative to continued violations of the code of conduct. The final warning indicated that RN, Staff C, had utilized her own personal glucometer and equipment rather than following the appropriate procedures to request new supplies for Patient ID #1. Review of the agency investigation of the 9/26/2024 incident revealed that Clinical Manager RN, Staff B documented that LPN, Staff A informed her that RN, Staff C used her personal glucometer to check the patient’s blood sugar on 5/16/2024. Further review of the documentation revealed that RN, Staff C left her own personal glucometer and equipment in the home for the other nurses to use. Review of the manufacturer’s instructions for use of the Contour Next Generation (left by the nurse) blood glucose monitoring system, states in part, “…The CONTOUR Next GEN blood glucose monitoring system is intended to be used by a single person and should not be shared…Potential Biohazard…All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection…Clean and disinfect your CONTOUR Next GEN meter once a week. Use only Clorox Healthcare Bleach Germicidal Wipes containing 0.55% sodium hypochlorite bleach…” Review of an annual evaluation dated 6/26/2024 and completed by Clinical Supervisor RN, Staff D, revealed RN, Staff C received a performance rating scale of “3” relative to following company policies and procedures and healthcare rules and regulations to include safety, documentation infection control. A rating of “3” indicated that her performance is consistently strong and meets all expectations of her role. Further review of this document lacked documentation of the infection control incidents on 7/20/2023 or 4/11/2024. Further review of the employee file lacked evidence that RN, Staff C had received re-education after the agency was notified on 9/27/2024 that she used her own personal glucometer to monitor a Patient’s blood sugar. During a telephone interview with the patient’s representative, on 11/12/2024 at 1:22 PM, she indicated that the patient did not have any lancets for “a couple of weeks” and that she was unaware how the agency nurses were monitoring his/her blood glucose levels when s/he has run out of supplies. During a surveyor interview with the Clinical Manager, RN Staff B, and the Administrator, on 11/12/2024 at 11:20 AM, the Administrator indicated that the annual evaluation completed for RN, Staff C should have included the previous infection control concerns identified from 2023 and 2024. During an interview with the Clinical Manager, RN Staff B, and the Administrator on 11/13/2024 at 12:13 PM, they were unable to provide evidence that the patient’s physician or patient representative had been notified of the failure in infection control practices. The complaint investigation which was completed on 11/13/2024 alleging poor infection control practices by nursing staff resulted in an Immediate jeopardy (IJ) deficiency related to G-680 Infection Control. Following identification of the IJ, a template was presented to the agency Administrator on 11/12/2024, the agency submitted an immediate corrective action plan on 11/12/2024 which indicated the following would be immediately implemented: -The Clinical Manager or clinical designee will provide education to all active RNs and LPNs regarding infection control prevention, cleaning of glucometers, disposal of sharps and use of supplies intended for single patient use on 11/12/24. -An email blast will also be sent to all active RNs and LPNs to educate regarding infection control prevention, cleaning of glucometers, disposal of sharps and use of supplies intended for single patient use on 11/12/24. The following educational information was verified as sent to all nursing staff via phone contact and email. On 11/13/2024 the State Survey Agency verified through staff interviews and document review; the agency had fully implemented their immediate plan of correction.”

“Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This Standard is not met as evidenced by: Based on record review and staff interview, it has been determined that the home care agency failed to provide additional education to staff, and a patient caregiver, in response to a recognized lapse in adherence to infection control practices for 1 of 2 clients reviewed, Patient ID #1. This requirement is NOT MET as evidenced by: Review of the agency policy titled, “Infection Control Program”, revised on 4/16/2021, states in part, “…Control of an infection or an infectious disease outbreak includes…Implementing appropriate nursing practices to limit the transmission of the infection…Prevention activities will include…not reusing supplies intended for single patient/client use…” Review of the record for Patient ID #1 revealed s/he was admitted to the home care agency with diagnoses including but are not limited to type 1 diabetes mellitus. Review of the care plan revealed physician orders to test his/her blood sugar every four hours. Review of two documents, dated 9/27/2024 and titled, “Corrective Action Form” and “Incident Report: Interview Summary” revealed that on 9/26/2024 LPN, Staff A reported to the Clinical Manager RN, Staff B that RN, Staff C left a dirty lancet in the patient’s diabetic lancing device. The report indicated that this is the 5th time she had found a dirty lancet in the work area. Additional review of these documents revealed that a final warning was given relative to continued violations of the code of conduct and indicated that RN, Staff C, “…utilized her personal glucometer and equipment rather than following the appropriate procedures to request new supplies…” Review of the agency’s investigation into the 9/26/2024 incident revealed that Clinical Manager RN, Staff B documented that LPN, Staff A informed her that RN, Staff C used her personal glucometer to check the patient’s blood sugar on 5/16/2024. Further review of the documentation revealed that RN, Staff C had left her own personal glucometer and equipment in the home for the other nurses to use because the patient was running low on lancets. During a telephone interview with RN Staff C, on 11/8/2024 at 9:45 AM, she acknowledged forgetting to remove used lancets after obtaining blood glucose readings for the patient on multiple occasions. Furthermore, she acknowledged that she utilized her own personal glucometer after cleaning it with alcohol, to monitor the patient’s blood glucose levels when s/he ran out of blood glucose supplies. Review of the manufacturer’s instructions for use of the glucometer, the Contour Next Generation blood glucose monitoring system, states in part, “…The CONTOUR Next GEN blood glucose monitoring system is intended to be used by a single person and should not be shared…Potential Biohazard…All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection…Clean and disinfect your CONTOUR Next GEN meter once a week. Use only Clorox Healthcare Bleach Germicidal Wipes containing 0.55% sodium hypochlorite bleach…” During a telephone interview with the patient’s representative, on 11/12/2024 at 1:22 PM, she indicated that the patient did not have the necessary supplies for “a couple of weeks” and she was unaware how the agency nurses were monitoring his/her blood glucose levels when s/he had run out of supplies. A review of the agency documentation lacked evidence that the agency notified, or provided the patient’s representative, with additional education relative to infection control regarding the above-mentioned incident. In addition, the documentation lacked evidence that Staff C was provided re-education relative to the reuse of a personal single use diabetic device for the patient after the agency became aware of the nurse’s lapse in adherence to proper, safe infection control practices. During an interview with the Clinical Manager, RN Staff B, and the Administrator on 11/13/2024 at 12:13 PM, they were unable to provide evidence that infection control procedures were followed, or that education was provided to either Staff C or the patient caregiver relative to Staff C’s lack of adherence to infection control standards.”

“Communication with all physicians CFR(s): 484.60(d)(1) Standard: Coordination of Care. The HHA must: (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 home care agency failed to communicate a failure in infection control practices provided by the agency with the Patients physician, or allowed practitioners, involved in the plan of care for 1 of 2 patients reviewed, Patient ID #1. Findings are as follows: Review of the record for Patient ID #1 revealed s/he was admitted to the home care agency with diagnoses including but not limited to hypoxia or hypercapnia (respiratory conditions that can cause shortness of breath), type 1 diabetes mellitus, epilepsy, reduction deformities of the brain, tracheostomy (an opening surgically created through the neck into the windpipe to allow air to fill the lungs), and gastrostomy (an opening into the stomach from the abdominal wall, made surgically for the introduction of food). Review of the care plan revealed a physician’s order to test his/her blood sugar every four hours. Review of two documents, dated 9/27/2024, titled, “Corrective Action Form” and “Incident Report”: Interview Summary” revealed that on 9/26/2024 LPN, Staff A reported to the Clinical Manager RN, Staff B that RN, Staff C left a dirty lancet and indicated that this is the 5th time she had found a dirty lancet in the work area. Additional review of these documents revealed that Staff C had received a final warning relative to continued violations of the code of conduct and indicated that RN, Staff C, “…utilized her personal glucometer and equipment rather than following the appropriate procedures to request new supplies…” A review of the agency’s investigation into this incident revealed that the Clinical Manager RN, Staff B documented that LPN, Staff A informed her that RN, Staff C used her personal glucometer to check the patient’s blood sugar on 5/16/2024. Further review of the documentation revealed that RN, Staff C left her own personal glucometer and equipment in the home for the other nurses to use. During a telephone interview with RN Staff C, on 11/8/2024 at 9:45 AM, she acknowledged that she left the used lancets after obtaining blood glucose readings for the patient on multiple occasions. Furthermore, she acknowledged that the patient ran out of blood glucose supplies for his/her own glucometer for approximately 2-3 weeks back in May and in response she used her own personal glucometer after cleaning it with alcohol to monitor the patient’s blood glucose levels. Staff C acknowledged she continued to use her own glucometer until the patient’s supplies were available. Review of the agency documentation failed to provide evidence that the patient’s physician, or allowed practitioner, were notified of this incident. During an interview with the Clinical Manager, RN Staff B, and the Administrator on 11/13/2024 at 12:13 PM, they were unable to provide evidence that either the patient’s physician or patient representative were notified of the failure in infection control practices used for Patient ID #1.”

“Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated 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 home care agency failed to provide services that were ordered by the physician, as indicated in the plan of care, for 1 of 2 patients reviewed, Patient ID #1. Findings are as follows: Review of the record for Patient ID #1 revealed s/he was initially admitted to the home care agency on 4/30/2019 with diagnoses including but were not limited to gastrostomy (G-tube, an opening into the stomach from the abdominal wall, made surgically for the introduction of food) and full incontinence of feces. Review of the plan of care revealed the following physician orders: Senna 8.8. milligrams/5 mL syrup as needed one time maximum via G-tube once daily as needed for no stool in 48 hours. Fleet Glycerin Laxative 5.4 gram/5.4 milliliter (mL) rectal solution, 1 suppository as needed for not stool in 3 days. Review of the agency grievance/complaint documentation revealed that on 8/23/2023 at 9:29 AM Licensed Practical Nurse (LPN), Staff A reported to the Clinical Supervisor, Registered Nurse (RN) Staff D that the patient had not moved his/her bowels since 8/19/2023 and was not administered a suppository per the physician’s order. Further review of the documentation revealed the Clinical Supervisor, RN Staff D notified the physician that the patient was not provided with any stool medications on 8/22/2203 for his/her constipation. During an interview with the Clinical Manager, RN Staff B, in the presence of the Administrator on 11/13/2024 at 11:55 AM, the Clinical Manager reviewed the patient’s medication administration record from August 2023 and indicated that the above-mentioned laxatives were not administered as ordered, and the record does not reflect if these medications were offered to the patient.”