Davita Cambridge Dialysis Center

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 44367 Based on clinical observations and interviews with the administrative staff, the facility’s governing body failed to ensure that all expired medications are removed and not available for use. This failure placed the patients at potential risk of infection and cross contamination. Findings include: Review on 01/30/2024 of the facility’s policy 1-06-01 entitled, “Medication Policy”, states, “All open or unused ampules and/or vials are stored according to the manufacturer’s directions. Do not use any ampule or vial that has been stored improperly or has expired.” 1. Inspection of the medication area on 01/30/2024 revealed 25 vials of Gentamicin 80 mg/2 ml, lot number 6128766 expired 12/2023. 2. Inspection of the medication area on 01/30/2024 revealed two (2) Narcan Nasal Spray lot number 202206 expired 12/2023. The Facility Administrator was informed of the findings on 01/30/2024.”

“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: 44367 Based on observations and review of the facility’s policies and procedures, the governing body and the medical director failed to ensure that the clinical staff complied with the appropriate catheter care techniques and procedures. This failure placed patients at potential risk of infection or harm in maintaining their central venous catheter. Staff: Patient Care Technician #1 (PCT #1) and #2 Findings include: According to the National Institute of Health (NIH), “A central venous catheter (CVC) is an indwelling device inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium [parts of the heart].” Review of the facility’s policy 1-04-02B entitled “Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps” states to “Perform a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines, such as during line reversal, or if the patient is disconnected during treatment for any reason.” The policy also states, “Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides and the end of the hub thoroughly... “Clean exit site with 2% Chlorhexidine Gluconate 70% Isopropyl Alcohol swab for a minimum of 30 seconds...Then wait 60 seconds for air dry time.” 1. During observation of the clinical treatment area on 01/30/2024 at 10:16 a.m., during initiation of treatment of a CVC patient at station 13, PCT #2 scrubbed the venous hub for 2 seconds and scrubbed the arterial hub for 3 seconds after removing the caps. PCT #2 cleaned the exit site, but only allowed the site to dry for 30 seconds prior to placing a clean dressing. 2. During observation of the clinical treatment area on 01/30/2024 at 11:03 a.m., during initiation of treatment of a CVC patient at station 7, PCT #1 did not scrub the arterial hub or venous hub after removing the caps, prior to placing the 10 cc syringe. During the dressing change, PCT #1 cleaned the exit site for 19 seconds and allowed the site to dry for 25 seconds prior to placing a clean dressing. The Facility Administrator was informed of the findings on 1/30/2024.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 44367 Based on observations, the Facility’s Administration and the Medical Director failed to ensure that the manual pH testing of the dialysis machine was performed before starting the treatment of each patient. This failure placed the patient affected at potential risk of harm. Staff: Patient Care Technician #1 (PCT #1) and PCT #3 Findings Included: Review on 1/30/2024 of the facility’s policy 2-08-01B entitled “Operation of Portable Myron L Conductivity Meter” revealed that the “Manual pH testing must be performed prior to each patient treatment.” 1. On 1/30/2024 at 10:13 a.m., Staff #3 did not check the manual pH for the machines at station 13 and station 14, prior to initiating the patient’s treatment. 2. On 1/30/2024 at 10:44 a.m., Staff #1 did not check the manual pH for the machines at station 20, prior to initiating the patient’s treatment. The Facility Administrator was informed of the findings on 1/30/2024.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 44367 Based on observations and a review of the facility’s policies and procedures, the facility’s governing body failed to ensure that patients were safely monitored by the assigned patient care technician after the dialysis treatment was initiated.This failure placed the patients at potential risk of harm. Staff: Patient Care Technician #1 (PCT #1) Findings include: Review on 01/25/2024 of the facility’s policy entitled, “Initial and Continuous Assessment of the Hemodialysis Patient Prior to and During Dialysis Treatment” stated, “To assess and evaluate the patient’s status prior to, during,and after dialysis...The patient will also be continuously monitored during the treatment to avoid any problems that may occur during this time.” 1. During observation of the clinical treatment area on 01/25/2024 at 12:15, the surveyor noted that PCT #1 was assigned to patients in station 12, 13, and 14 area; However, PCT #1 was sitting in the medication area, which is approximately 75 feet away on the opposite side of the the assigned patients, with his/her back turned towards the patients on a cell phone for approximately 10 minutes. The surveyor asked PCT #1 if he/she could monitor the assigned patients properly from the medication area. PCT #1 stated “yes” and then stood on chair rest looked over at the patient and stated, “like this.” PCT #1 then sat back down and continued to manipulate his/her cell phone. The Facility Administrator was informed of the findings on 01/25/2024.”

“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: 44367 Based on observations and a review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the facility removed all expired supplies from the supply sources to prevent expired supplies being used or given to patients. This failure placed the patients at potential risk of harm. Findings include: When medications and supplies are no longer needed, they should be disposed of promptly. Healthcare providers should remove expired medications and supplies as quickly as possible to help reduce the chances that others accidentally receive or intentionally misuse them. 1. Inspection of the water treatment room on 01/25/2024 revealed one (1) bottle of Conductivity Solution 14 ms/cm, lot number 14220321 expired 3/21/2023. 2. Inspection of the clinical treatment area on 1/25/2024 revealed the following expired supplies: · 100 EZ pH Check Test Strips, lot number 105037 · 10 Light Blue BD Vacutainer Blood Collection Tubes, lot number 2074237, expired 12/31/2023. · Three (3) 0.2 Micron Filter Extension Set 17 inch, lot number 5005713, expired 10/31/2023. · 50 Recirculation Caps, lot number 2000133, expired 12/23/2023. The Facility Administrator was informed of the findings on 01/25/2024.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies and procedures, the facility’s administration and the Medical Director failed to ensure that the clinical staff complied with the appropriate procedures when assessing the patients’ vascular access prior to cannulation and practiced the correct infection control protocol. This failure placed the safety and wellbeing of the patients at potential risk of harm in maintaining their vascular access. Staff: Patient Care Technician #1 (PCT #1) Findings included: Review on 01/25/2024 of the facility’s policy 01-04-01E entitled “Cannulation of Fistula or Graft” states “Do not palpate insertion site once area has been prepped. Rationale: Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.” Review on 01/25/2024 of the facility’s policy entitled “AV Fistula or Vein Graft - Initiating Dialysis for Mature Access” states that, “Before initiating dialysis the Dialysis Tech or nurse shall determine the integrity of the vascular access by palpating for a thrill and auscultating for a bruit...Aseptic technique shall be followed when initiating dialysis.” 1. Observation of the clinical treatment area on 01/25/2024 at 10:57 a.m. revealed that during treatment initiation of a AVF/AVG patient at station 12, PCT #1 did not listen for a bruit prior to cannulation. PCT #1 touched the access after disinfection and prior to cannulation. PCT #1 did not re-clean the access. 2. Observation of the clinical treatment area on 01/30/2024 at 10:35 a.m. revealed that during treatment initiation of a AVF/AVG patient at station 7, PCT #1 did not listen for a bruit prior to cannulation. PCT #1 touched the access after disinfection and prior to cannulation. PCT #1 did not re-clean the access. The Facility Administrator was informed of the findings on 01/25/2024 and 01/30/2024.”