Davita Dialysis Center of Erie

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 44820 Based on observations(OBS), review of facility policy and procedure and interview with facility employees (EMP), the facility failed to maintain a sanitary environment for 1 (one) of 1 (one) observation. (OBS #1) Findings include: A review of facility procedure: “1-06-01 A” conducted on 11/7/2024 at approximately 2:20 pm revealed: Title: “Preparation and administration of Pareteral medications... “ Revision: “April 2024” states: “ ...Procedure ...17. Distribute the medication to the patient station... place patient’s syringe(s) in a recloseable plastic bag if medication is not administered immediately. “ A review of facility procedure: “1-05-01” conducted on 11/7/2024 at approximately 2:30 pm revealed: Title: “Infection control for dialysis facilities”... “Facility Hygiene: 16. Clean areas should be clearly designated for the preparation, handling and storage of medications... clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled...” OBS#1 on 11/7/2024 at approximately 9:20 am: Surveyor observed approximately 16 - syringes labeled with patient name, date, time, initials of preparer and medication lying directly on nurses station counter. None of the syringes were in individual bags. None of the syringes were placed in a designated “clean” environment. On 11/7/2024 at approximately 09:25 am interview conducted with RN1 and PCT 1 that confirmed findings. PCT1 states “That is how the nurse gets the heparin ready for us before the patients arrive.””

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 44820 Based on observations (OBS), review of facility policy and procedure and interview with facility employees (EMP), the facility did not ensure precautions were in place to maintain a clean environment to prevent the possibility of spreading infectious diseases for 1 (one) of 2 (two) observations. (OBS#1) Findings include: A review of facility procedure: “1-05-01” conducted on 11/7/2024 at approximately 2:30 pm revealed: Title: “Infection control for dialysis facilities”... “Facility Hygiene: 16. Clean areas should be clearly designated for the preparation, handling and storage of medications... clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled...” OBS#1- conducted on 11/7/2024 at approximately 9:35 am: Surveyor witnessed staff personal coats, color black, placed on a wall hook with used “ dirty “ white gown PPE. Area not clearly designated “clean” or “dirty” Surveyor interview with EMP at approximately 9:36 am to clarify area designation confirms area is designated “clean”. EMP#1 states “I don’t know why the white gown is there. It is a clean area for us to hang our personal belongings. “ 11/7/2024 at approximately 9:35 am EMP#1 confirmed above findings.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 44820 Based upon a review of facility policy, review of manufacturer’s direction for use, facility policy, treatment area observations (OBS), and an interview with the Nurse and Facility Administrator, facility failed to ensure staff maintained aseptic technique for the care of vascular accesses, including intravascular catheters, for one (1) of two (2) observations (OBS #1). Findings include: On 11/7/2024 at approximately 12:15 p.m. a review of Manufacturer’s direction for use - Chloraprep One-Step (2% Chlorahexidine gluconate/ 70% Isopropyl alcohol) antiseptic swab states”...dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds...” On 11/7/2024 at approximately 1:00 p.m. a review of policy procedure: “1-04-02B” Title “Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps procedure”...Device Disinfectant and Skin Antiseptic - 2% Chlorhexidine Gluconate/70% isopropyl Alcohol... procedure step number 8. ... clean exit site with 2% Chlorhexidine Gluconate/0% Isopropyl Alcohol swaab for a minimum of 30 seconds, apply to the CVC exit site in a “back and forth” pattern... “ Observations conducted in patient treatment area on 11/7/2024 between approximately 9:30 a.m.-12:00 p.m. revealed the following: OBS #1: During observation of Central Venous Catheter (CVC) Exit Site Care on 11/7/2024 at approximately 9:30 a.m., station #17, Employee # 12 cleansed area around the CVC exit site, starting from the insertion site and moving outward in a spiral circular motion with a Chloraprep One-Step (Chlorahexidine swabstick) antiseptic swab. An interview with Nurse and Facility Administrator on 11/7/2024 at approximately 3:00 p.m. confirmed the above findings. EMP#12 states “The procedure is a circular motion from inside, closest entry point, to outside away from the catheter making a spiral.””

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 44820 Based on reviews of policies/procedures, Daily Verification forms and interview with the Bio-Med Technician, the clinic failed to ensure chemicals used incenter were properly stored according to policy and procedures for 24 out of 27 dates reviewed from 10/8/2024 through 11/7/2024. Findings include: Reviews of policies completed on 11/7/2024 between approximately 1:00 p.m. and 3:00 p.m. revealed: Policy: “1-22-01”; Title: “Chemical Use Policy”... Policy: “1. Peracetic Acid is to be stored separate from other chemicals, especiall bleach. It is to be stored in a cool, dry area (32 degrees F - 75 degrees F)...” Review of Peracetic acid and CM130 reagent temperature storage log conducted on 11/7/2024 between approximately 1:00 p.m. and 1:15 p.m. revealed: On 10/8/2024: Minncare (Peracetic acid), documented temperature: 80 degrees F. On 10/9/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 10/11/2024: Minncare (Peracetic acid), documented temperature: 76 degrees F. On 10/12/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 10/14/2024: Minncare (Peracetic acid), documented temperature: 76 degrees F. On 10/16/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 10/17/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 10/19/2024: Minncare (Peracetic acid), documented temperature: 76 degrees F. On 10/21/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 10/22/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 10/23/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 10/24/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 10/25/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 10/26/2024: Minncare (Peracetic acid), documented temperature: 80 degrees F. On 10/28/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 10/29/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 10/30/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 10/31/2024: Minncare (Peracetic acid), documented temperature: 80 degrees F. On 11/1/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 11/2/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 11/4/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. On 11/5/2024: Minncare (Peracetic acid), documented temperature: 76 degrees F. On 11/6/2024: Minncare (Peracetic acid), documented temperature: 76 degrees F. On 11/7/2024: Minncare (Peracetic acid), documented temperature: 78 degrees F. Interview with the BioMed Technician conducted on 11/7/2024 at approximately 1:30 p.m. confirmed the above findings.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 44820 Based on review of policy, clinical records (CR) and interview with the facility administrator the clinic failed to ensure the nurse documented interventions for the patient leaving treatment more than 1 kg over the estimated dry weight, the clinic failed to ensure documentation of interventions for “abnormal findings” per policy, the clinic failed to ensure facility staff notified and documented that the nurse was notified if patient BP’s recorded contained systolic greater than 180 mm/Hg or below 90 mm/Hg, the clinic failed to ensure patient received medications as prescribed by the physician, the clinic failed to ensure and document that the patient received the prescribed dialysis treatment time and the clinic failed to ensure all medications orders contained frequency and parameters for administration, the clinic failed to ensure physician was notified for three (3) of nine (9) records reviewed (CR#1, CR#2 and CR#3). Findings include: Review of Policy “1-03-08” TITLE: “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT” completed on 11/5/2024 at approximately 11:00 AM revealed: PURPOSE: “To obtain and document baseline and ongoing inforamtion about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring duringtreatment and for reviewing the patient’s response to treatment and status prior to discharge... POLICY: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. a. Data collection includes butisnotnecessarily limited to:... ii. Measurement of Blood Pressure (BP); 1. Sitting and standing BP measurement required pre and post treatment (if patient unable to stand, document reason in patient electronic record or flow sheet)... PRE-TREATMENT DATA COLLECTION/ASSESSMENT; 4. Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse... 10. If the dialysis prescription is not being met... the reason will be documented and the licensed nurse informed... 13. All findings, interventions and patient response will be documented in the patient’s medical record... 16. If an abnormal finding or concern is identified post treatment, this needs to be reported to the licensed nurse... 17. Licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions or notification of physician is necessary prior to discharge of the patient from the facility... ABNORMAL FINDINGS; ... The following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record... Fluid Status... Post-treatment: If patient is above or below 1 kg from the target weight... Blood Pressure: Pre-dialysis: Systolic greater than 180mm/Hg or less than 90mm/Hg... Blood Pressure-Intradialytic: Systolic greater than 180mm/Hg or less than 90mm/Hg... Blood Pressure Post Treatment: If the patient can stand: standing Systolic BP greater than 140mm/Hg or less than 90mm/Hg; If patient is not able to stand, document reason and sitting BP... Pre/Intra/Post Patient Reports/Complaints and/or teammate observation of:... Weakness or numbness... Changes in mobility, ambulation or reports of falls...” Review of CR’s completed on 11/6/2024 between approximately 10:30 AM and 11:30 AM; 11/8/2024 between 3:00 PM and 3:30 PM and 11/12/2024 between approximately 9:00AM and 3:00pm revealed: CR#1, Admit date: 9/28/2023; Mobility: ambulates - device needed - Walker Treatment date: 11/5/2024: standing BP not documented pre-treatment - No documented interventions by nurse. Treatment date: 11/2/2024: standing BP not documented pre-treatment, target weight 96 kilograms (kg) post-treatment weight documented 94.5 kg - no documented interventions by nurse. Treatment date: 10/31/2024: standing BP not documented pre-treatment; Dialysis prescription treatment time ordered: 3 hours 30 minutes - treatment start time 12:34pm - treatment end time 15:18 pm; Heparin Pork 400 units/Hr, Intravenous infusion, every dialysis treatment - not administered; No documented interventions by nurse/no physician notification documented. Treatment date: 10/29/2024: standing BP not documented pre-treatment; Heparin Pork 1,000 Units, Intravenous; Push, Every dialysis treatment - not administered; Heparin Pork 400 units/Hr, Intravenous infusion, every dialysis treatment - not administered; No documented interventions by nurse/no physician notification documented. Treatment date: 10/26/2024: standing BP not documented pre-treatment; Heparin Pork 1,000 Units, Intravenous; Push, Every dialysis treatment - not administered; Heparin Pork 400 units/Hr, Intravenous infusion, every dialysis treatment - not administered; No documented interventions by nurse/no physician notification documented. Treatment date: 10/24/2024: standing BP not documented pre-treatment; Heparin Pork 1,000 Units, Intravenous; Push, Every dialysis treatment - not administered; Heparin Pork 400 units/Hr, Intravenous infusion, every dialysis treatment - not administered; Target weight - 96.0kg - Post weight documented 98.7kg. Mupirocin 1(one) application, external, every dialysis treatment ordered - not administered. No documented interventions by nurse/no physician notification documented. Treatment date: 10/22/2024: standing BP not documented pre-treatment; Target weight - 96.0kg - Post weight documented 98.9kg. Mupirocin 1(one) application, external, every dialysis treatment ordered - not administered. No documented interventions by nurse/no physician notification documented. Treatment date: 10/19/2024: standing BP not documented pre-treatment; Target weight - 96.0kg - Post weight documented 98.2kg. No documented interventions by nurse/no physician notification documented CR#2, Admit date: 1/30/2024; Mobility: ambulates - assistance needed. Treatment date: 11/5/2024: standing BP not documented pre-treatment; treatment time prescribed 3 hours 30 minutes - not achieved (treatment start time 11:47am - end time 15:03pm). No documented interventions by nurse/no physician notification documented. Treatment date: 11/2/2024: standing BP not documented pre-treatment; Target weight prescribed - 54 kg - post weight recorded 55kg. No documented interventions by nurse/no physician notification documented. Treatment date: 10/31/2024: standing BP not documented pre-treatment; No documented interventions by nurse/no physician notification documented. Treatment date: 10/29/2024: standing BP not documented pre-treatment; No documented interventions by nurse/no physician notification documented. Treatment date: 10/26/2024: standing BP not documented pre-treatment; No documented interventions by nurse/no physician notification documented. Treatment date: 10/24/2024: standing BP not documented pre-treatment; No documented interventions by nurse/no physician notification documented. Treatment date: 10/22/2024: standing BP not documented pre-treatment; Mupirocin 1(one) application, external, every dialysis treatment ordered - not administered. No documented interventions by nurse/no physician notification documented. Treatment date: 10/19/2024: standing BP not documented pre-treatment; No documented interventions by nurse/no physician notification documented. CR#3, Admit date: 9/19/2024; Mobility: ambulates - no assistance needed. Treatment date: 11/2/2024: standing BP not documented pre-treatment; Target weight prescribed - 75 kg - post weight recorded 76.8kg. No documented interventions by nurse/no physician notification documented. Treatment date: 10/29/2024: standing BP not documented pre-treatment; No documented interventions by nurse/no physician notification documented. Treatment date: 10/26/2024: standing BP not documented pre-treatment; pre-treatment sitting BP 246/146 documented at 11:22am - registered nurse (RN) assessed- No documented interventions by nurse; 11:28 am treatment initiated - BP 235/141 - RN assessed- No documented interventions by nurse; 11:33am BP 236/128- No documented interventions by nurse; 12:03pm BP 219/110 - RN monitoring - No documented interventions by nurse; 12:20pm - clonidine 0.1 mg prn administered by RN - clonidine orders do no contain parameters for administration or frequency; post treatment BP 199/113 - No documented interventions by nurse/no physician notification documented. Treatment date: 10/22/2024: standing BP not documented pre-treatment; pre-treatment sitting BP 217/119 documented at 11:00am - registered nurse (RN) assessed- No documented interventions by nurse; 11:02 am treatment initiated - BP 187/113- RN assessed- No documented interventions by nurse; 11:13am clonidine 0.1 mg prn administered by RN - clonidine orders do no contain parameters for administration or frequency; 11:37 am BP 194/106 - No documented interventions by nurse; 12:02pm BP 184/102 - RN monitoring - No documented interventions by nurse; 12:32pm BP 185/93 - clonidine 0.1 mg prn administered by RN - clonidine orders do no contain parameters for administration or frequency; post treatment BP Sitting: 201/114; post treatment BP standing: 202/122 - No documented interventions by nurse/no physician notification documented. Interview with the Facility Administrator completed 11/7/2024 at 3:30PM 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: 44820 Based upon a review of facility policy, review of facility policy, treatment area observations (OBS), and an interview with the Nurse and Facility Administrator, the Medical Director failed to ensure staff maintained aseptic technique for the care of vascular accesses arteriovenous fistulas (AVF), including intravascular catheters (CVC) per policy, for one (1) of two (2) observations (OBS #1). Findings include: A review on 11/5/2024 at approximately 2:45 of Incenter Hemodialysis Policies & Procedures Davita Inc. revealed: Procedure: “1-04-01E” Title: “AV Fistula or graft cannulation... Procedure... step number 5. Perform inspection, auscultation and palpation on entire length of access... step number 8. Locate and palpate needle cannulation sites prior to skin preparation... step number 10. while maintain aseptic technique, prep each planned needle site by applying a 70% alcohol prep pad to each site... step number 13. Do NOT palpate insertion site once area has been prepped... step number 18. while maintaining aseptic technique, grasp the wings of appropriate fistula needle and remove cap...” Observations conducted in patient treatment area on 11/5/2024 between approximately 10:30 a.m.-1:00 p.m. revealed the following: OBS #1 occurred on 11/5/2024 at approximately 12:20 pm station # 12, Pod “A”, patient “DW”. PCT failed to maintain aseptic technique and failed to adhere to policy and procedure by surveyor observation. Observation revealed PCT performing preparation of AVF for cannulation by applying 70% alcohol prep pad per policy and then PCT was observed auscultating AVF (ateriovenous fistula) with a stethoscope after prep was completed and immediately cannulated AVF. PCT did not cleanse/prep site again prior to cannulating. An interview with the staff/employee (EMP) and PCT conducted on 11/5/2024 at approximately 12:35 PM confirmed the above findings.”