Davita Pocono Home Training

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 36372 Based on a review of facility policy, a review of medical records, and an interview with the facility Administrator, facility failed to ensure that patient Hepatitis B status was known before admission and prior to first treatment for two (2) out of six (6) medical records (MR) reviewed (MR#1, MR#6). Findings: A review was conducted of facility policies/procedures on July 10, 2025 at approximately 8:30 a.m. Policy: 1-05-02 ‘Hepatitis B Surveillance, Vaccination, Infection Control Measures, and Isolation Guidance’ ‘Policy’ (1) “HBV serological status ...... of all patients should be known before admission to the hemodialysis facility.” (2) “If hepatitis B surface antigen ... is unknown, the facility Medical Director will be notified and the patient treated as a suspect patient for hepatitis B infection. ...” A review of patient medical records was completed on July 9, 2025 at approximately 3:00 p.m. Patients date of admit is included below. MR#1 Date of Admission 08/08/22: Patient’s first treatment date at the facility was 08/08/22 (‘Start Time: 10:10, Stop Time: 12:45’). No documentation provided of the patients hepatitis B status before admission to the facility and prior to the first treatment. Documentation provided of the facility hepatitis B testing on 08/08/22. MR#6 Date of Admission 03/31/25: Patient’s first treatment date at the facility was 03/31/25. No documentation provided of the patients hepatitis B status before admission to the facility and prior to the first treatment. Patient was treated four (4) days at the facility with hepatitis B status unknown (last treatment day, prior to facility receiving hepatitis B lab results, was 04/03/25). According to documentation provided of a facility adverse event report, the treatment room was utilized by other patients during this time period. The Medical Director and Davita management team was notified on 04/03/25. The treatment room was terminally cleaned on 04/04/25. Documentation provided of ‘Hepatitis B DNA, Quantitative PCR’ test ordered on 04/04/25 with results (negative/non-reactive) obtained on 04/07/25. An interview conducted with the facility Administrator on July 9, 2025 at approximately 3:30 p.m. and email correspondence with the facility Administrator on July 10, 2025 at approximately 9:30 a.m. confirmed the above findings.”

“H-TRAIN CONTENT INCLUDES ER PREP HOME PTS CFR(s): 494.100(a)(3) The training must- (3) Be conducted for each home dialysis patient and address the specific needs of the patient, in the following areas: (i) The nature and management of ESRD. (ii) The full range of techniques associated with the treatment modality selected, including effective use of dialysis supplies and equipment in achieving and delivering the physician’s prescription of Kt/V or URR, and effective administration of erythropoiesis-stimulating agent(s) (if prescribed) to achieve and maintain a target level hemoglobin or hematocrit as written in patient’s plan of care. (iii) How to detect, report, and manage potential dialysis complications, including water treatment problems. (iv) Availability of support resources and how to access and use resources. (v) How to self-monitor health status and record and report health status information. (vi) How to handle medical and non-medical emergencies. (vii) Infection control precautions. (viii) Proper waste storage and disposal procedures. This Standard is not met as evidenced by: 36372 Based on a review of facility policy, patient interviews, and an interview with the facility Administrator, facility failed to ensure home dialysis patients have access to resources and assistance 24 hours/day, 7 days/week, for one (1) out of two (2) patient interviews conducted (Interview #1). Findings: A review was conducted of facility policies/procedures on July 10, 2025 at approximately 8:30 a.m. Policy: 5-01-04 ‘Services Provided’ ‘Policy’ section (4) “The facility will provide ongoing services, including, but not limited to: .......Identify 24 hour coverage. ....” (5) The facility will provide the patient/care partner with the facility’s normal operating hours and contact information. In addition, the patient/caregiver will be provided with contact information for after hours and emergency issues.” Patient interviews were conducted at the facility on July 7, 2025 between approximately 10:15 a.m. and 11:00 a.m. Interview #1: An interview was conducted onsite with patient #7 (home hemodialysis patient) on 07/07/25 at approximately 10:15 a.m. The patient stated that between the hours of 4:00 p.m. - 5:00 p.m. there is no patient support. Stated facility closes at 4:00 p.m. and that the on-call service does not accept calls until 5:00 p.m. Stated complaints have been entered in the past. Discussed the patients concern with the faciltiy Administrator on 07/07/25. No complaints regarding this issue were noted in the facility complaint/incident log. Administrator completed a complaint entry on 07/08/25 at approximately 1:20 p.m. The entry included “ ...nurses typically leave around 4:30 p.m. The nurse on-call hours start at 5:00 p.m. Patient reports she has been told by the on-call system that she needs to wait to resolve her issues until after 5:00 p.m.” The complaint entry resolution section states “Brought to the awareness of the ROD to discuss/review a possible solution to the issue.” An interview conducted with the facility Administrator on July 9, 2025 at approximately 3:30 p.m. and email correspondence with the facility Administrator on July 10, 2025 at approximately 9:30 a.m. confirmed the above findings.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 36372 Based on a review of facility policy, patient medical records, water treatment equipment records, and an interview with the facility Administrator, the facility failed to ensure a registered nurse completed an initial nursing evaluation prior to initiating treatment for two (2) of six (6) medical records (MR) reviewed (MR #1, MR #3); failed to ensure facility forms were completed per policy/procedure, for one (1) of one (1) dialysis machine maintenance logs reviewed. (Log #1); and failed to ensure physician medication orders were transcribed correctly into patients home dialysis machine for one (1) of two (2) home hemodialysis patient medical records reviewed (MR#1). Findings: A review was conducted of facility policies/procedures on July 10, 2025 at approximately 8:30 a.m. Policy: 1-03-07 ‘Initial Patient Nursing Assessment For New Patients’ section (1) “A registered nurse (RN) as required by federal regulation will perform an initial pre-treatment evaluation of all patients prior to the initiation of their first treatment at the facility.” Section (4) “This initial pre-treatment evaluation will be documented in the electronic health record as the intitial Patient Nursing Assessment. In the event of system downtime, it may be documented on paper using the New Patient Pre-Treatment Initial Nurse Assessment form ...and is to be entered into CWOW when system comes back on-line.” MR#1 Date of Admission 08/08/22: Patient’s first peritoneal dialysis treatment nursing note dated 08/08/22 was reviewed. The ‘New PD Patient Pre-Treatment Initial Nurse Assessment’ documentation was completed on 08/08/22. No registered nurse signature/time stamp/date was included on the form. The section was left blank. MR#3 Date of Admission 06/09/25: Patient’s first peritoneal dialysis treatment nursing note dated 06/09/25 was reviewed. No documentation provided of an initial nursing assessment to determine the patients immediate needs. Procedure: 12-13-11-A ‘Home Hemodialysis Policies and Procedures’ section (9) “Bleach Waste Line: The Bleach Waste Line procedure is completed at least weekly or as often as needed, when in use.....” (10) “Verified by an RN: An RN will verify that maintenance log is complete.” A review of dialysis machine maintenance logs was completed on July 9, 2025 at approximately 11:00 a.m. Log #1: The ‘NxStage Maintenance Schedule Logs’ dated 2023 - 2025 review revealed the following: Cycler Serial #16691: 2023 (January - December)....’Initials of RN reviewing’ section blank with no entries. 2024 (January - December)....’Initials of RN reviewing’ section blank with no entries. 2025 (February - June)....’Initials of RN reviewing’ section blank with no entries. Cycler Serial #12442: 2025 (March - June)....’Initials of RN reviewing’ section blank with no entries. ‘Bleach Waste Line’ section dates between 3/5/25 and 3/31/25 blank with no entries. Cycler Serial #8541: 2023 (January - December)....’Initials of RN reviewing’ section blank with no entries. 2024 (January - December)....’Initials of RN reviewing’ section blank with no entries. 2025 (February - June)....’Initials of RN reviewing’ section blank with no entries. Cycler Serial #17512: 2024 (January - December)....’Initials of RN reviewing’ section blank with no entries. Cycler Serial #13372: 2023 (January - December)....’Initials of RN reviewing’ section blank with no entries. Policy:3-02-03 ‘Physician Orders For Patient Care’ ‘Purpose’ “To verify that orders are properly documented, transcribed, verified, and implemented in a timely manner for patient care ....” Policy: 12-01-41 ‘Daily Home Treatments Record (Flowsheet)’ ‘Policy’ (3) (a) “The licensed nurse ...will review the patients data via the submitted Daily Home Treatment Records.” (d) “The licensed nurse is responsible for end of month review for all Daily Home Treatment Records ....” A review of patient medical records was completed on July 9, 2025 at approximately 3:00 p.m. Patients date of admit is included below. MR#1, Date of admit 08/08/22: Physician ‘Medication Order’ (Active) “Heparin Pork (At home), Loading dose 3,000 units, every dialysis treatment, intravenous, flush.” Start Date: 10/02/22. Patient treatment flowsheets were reviewed from 04/10/25 - 6/23/25. ‘Prescription’ section includes but is not limited to “Heparin Dose: 4,000 units.” ‘Medication’ administration section blank with no entries. A telephone interview was conducted on 07/09/25 at approximately 2:00 p.m. with the facility home hemodialysis registered nurse.(employee #7). Employee #7 stated the error 4,000 units of heparin listed on the treatment flowsheet was overlooked during treatment flow sheet reviews. When documentation was requested of the patient being educated on completing the ‘Medication’ administration section of the treatment flowsheet, no documentation was provided. An interview conducted with the facility Administrator on July 9, 2025 at approximately 3:30 p.m. and email correspondence with the facility Administrator on July 10, 2025 at approximately 9:30 a.m. confirmed the above findings.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 36372 Based on a review of facility policy, inspection of emergency evacuation kit contents, and an interview with the facility Administrator, facility failed to ensure patient records were safeguarded against unauthorized use for one (1) out of one (1) emergency evacuation kit inspections (Inspection #1). Findings: A review was conducted of facility policies/procedures on July 10, 2025 at approximately 8:30 a.m. ‘Facility Emergency Management Plan (ICHD, Home)’ ‘Emergency Evacuation Kit’ section (6) “Each evacuation kit/s should contain: (a) Copy of each patients treatment orders and medication list. FA or designee will verify patient information is updated and replaced at least monthly. (8) “Evacuation Kit will be sealed with a break away lock ...” An inspection of the facility emergency evacuation kit on 07/09/25 at approximately 11:00 a.m. revealed the following: Inspection #1: The emergency evacuation kit (wheeled cart) was observed next to the nursing station/treatment room area entry/exit door to the patient waiting room. The ‘Patient Summary Reports’ log was marked accordingly and was sitting on top of the wheeled cart, unsecured with easy access. The contents of the log (Patient Summary reports) contain confidential patient information which includes but is not limited to patient patient phone number, dialysis start dates, allergies, health diagnosis, dialysis access, and dialysis treatment orders. The log did not contain Patient Summary reports for all facility patients. No home hemodialysis patients were in the log (seven patients, patients #1, #5, #7, #9 - #12) and two peritoneal dialysis patients (patient #3, patient #8) were not in the log. An interview conducted with the facility Administrator on July 9, 2025 at approximately 3:30 p.m. and email correspondence with the facility Administrator on July 10, 2025 at approximately 9:30 a.m. confirmed the above findings.”