Davita Renal Center of Orange

“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: 35561 Based on observation, interview, and review of policy, the facility failed to ensure one of one Licensed Vocational Nurses (Licensed Vocational Nurse (LVN)1) observed, implemented proper infection control measures during initiation and/or discontinuation of dialysis through a Central Venous Catheter (CVC) access, (a large plastic tube placed in a vein in the neck or groin for exchange of blood to and from the hemodialysis machine during the hemodialysis treatment). Failure to use recommended infection control practices increases the relative risk for bacteremia in patients with dialysis catheters. This deficient practice had the potential to affect 17 current and, all future facility patients that dialyzed with CVC accesses. Findings include: On 01/19/24 at 11:20 AM, LVN1 was observed initiating hemodialysis for an unidentified patient with a CVC access at Station 14. When performing care of the catheter insertion site LVN1 was noted to clean the skin outside in, progressing from the periphery of the area inward, leaving the catheter insertion to be cleaned last, with the same swab. On 01/19/24 at 12:15 AM, LVN1 was observed initiating hemodialysis for an unidentified patient with a CVC access at Station 3. When performing care of the catheter insertion site LVN1 was again noted to clean the skin outside in, progressing from the periphery of the area inward, leaving the catheter insertion to be cleaned last, with the same swab. During an interview on 01/19/24 at 2:30 PM, LVN1 stated that she was not aware that cleaning the insertion site of a catheter with an alcohol swab that already been used to clean the patient’s surrounding skin could be a source of contamination. During an interview on 01/19/24 at approximately 3:00PM., these findings were discussed with the Facility Administrator at which time the Facility Administrator responded, “These observations do not meet the requirements of our infection control policy for care of a central venous catheter.” Review of the facility’s policy titled, “Central Venous Catheter Procedure,” last revised 10/2023, revealed, “Clean exit site with ... swab for a minimum of 30 seconds, apply to the CVC exit site in a ‘back and forth’ pattern, using gentle friction progressing from the insertion site to the periphery.””

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 35561 Based on observation and interview, the facility failed to ensure that the building in which dialysis services were furnished was maintained free from damage and defects to ensure the safety of the patients, staff and public. The failure to maintain the integrity of all surfaces interferes with effective cleaning and provides for the potential for microbial growth. This deficient practice allows the potential for cross-contamination of blood or body fluids and could lead to transmission of bloodborne pathogens, potentially affecting all patients receiving treatment at this dialysis clinic. Findings include: Observation during an environmental tour on 01/19/24 at 12:30 PM, conducted with the Facility Administrator revealed the following: 1.The stainless sink adjacent to Station 2 was noted to be stained throughout the basin with a one half inch area of thick black corrosion surrounding the facet. The lack of an intact sink surface rendered the sink unable to be thoroughly disinfected. 2.The Styrofoam ceiling tiles above Station 15 were observed to be warped and bent causing them to be loose and not secured. The lack of secure ceiling tiles immediately above a patient treatment station created a safety hazard. Interview during this observational tour on 01/19/24 at 12:30 PM, the Facility Administrator acknowledged that the lack of intact surfaces and loose ceiling tiles presented a potential safety hazard. The Facility Administrator stated, “we have tried to clean that sink several times, but the corrosion comes right back.””

“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: 35561 Based on observation, staff interview, review of policies and procedures, and review of manufacturer’s instructions for use, the facility failed to ensure one of one Registered Nurses (Registered Nurse (RN), one of one Licensed Vocational Nurses (Licensed Vocational Nurse (LVN)1, and three of four Patient Care Technicians (Patient Care Technicians (PCT)1, PCT2, PCT3) who were observed during care delivery, prepared the dialyzers (artificial kidney) by discarding the saline prime in accordance with the manufacturer’s instructions for use prior to initiating the dialysis treatment. Failure to ensure that all equipment is operated in accordance with the manufacturer’s recommendations had the potential to adversely affect safe in center dialysis treatments for all patients. This deficient practice had the potential to affect all 48 current patients receiving hemodialysis treatments. Findings include: During observation on the dialysis treatment floor on 01/17/24 at 11:10 AM, PCT2 was observed at Station 11 initiating a dialysis treatment for an unsampled patient. It was noted PCT2 failed to refresh the normal saline (0.9% salt solution) contained within the extracorporeal circuit (circuit consisting of the artificial kidney and bloodlines) as required. Instead, when initiating the dialysis treatment, PCT2 was observed infusing the recirculated normal saline into the patient. On 01/17/24 at 10:30 AM, at Station 10, PCT1 was observed initiating a dialysis treatment for an unsampled patient. It was noted PCT1 failed to refresh the normal saline contained within the extracorporeal circuit as required. Instead, when initiating the dialysis treatment, PCT1 was noted to infuse the recirculated normal saline into the patient. On 01/19/24 at 10:40 AM, at Station 9, PCT2 was observed initiating a dialysis treatment for an unsampled patient. It was noted PCT2 failed to refresh the normal saline contained within the extracorporeal circuit as required. Instead, when initiating the dialysis treatment, PCT2 was noted to infuse the recirculated normal saline into the patient. On 01/17/24 at 11:00 AM, at Station 5, RN1 was observed initiating a dialysis treatment for an unsampled patient. It was noted RN1 failed to refresh the normal saline contained within the extracorporeal circuit as required. Instead, when initiating the dialysis treatment, RN1 was noted to infuse the recirculated normal saline into the patient. On 01/19/24 at 9:40 AM, at Station 13, PCT3 was observed initiating a dialysis treatment for an unsampled patient. It was noted PCT 3 failed to refresh the normal saline contained within the extracorporeal circuit as required. Instead, when initiating the dialysis treatment, PCT3 was noted to infuse the recirculated normal saline into the patient. On 01/19/24 at 10:00 AM, at Station 11, PCT3 was observed initiating a dialysis treatment for an unsampled patient. It was noted PCT3 failed to refresh the normal saline contained within the extracorporeal circuit as required. Instead, when initiating the dialysis treatment, PCT3 was noted to infuse the recirculated normal saline into the patient. When asked if it was necessary to “rinse out the kidney” before initiating the dialysis treatment, PCT3 responded “we don’t do that anymore.” On 01/19/24 at 10:45 AM, at Station 16, RN1 was observed initiating a dialysis treatment for an unsampled patient. It was noted RN1 failed to refresh the normal saline contained within the extracorporeal circuit as required. Instead, when initiating the dialysis treatment, RN1 was noted to infuse the recirculated normal saline into the patient. On 01/19/24 at 11:15 AM, at Station 7, RN1 was observed initiating a dialysis treatment for an unsampled patient. It was noted RN1 failed to refresh the normal saline contained within the extracorporeal circuit as required. Instead, when initiating the dialysis treatment, RN1 was noted to infuse the recirculated normal saline into the patient. On 01/19/24 at 12:15 AM, at Station 3, LVN1 was observed initiating a dialysis treatment for an unsampled patient. It was noted LVN1 failed to refresh the normal saline contained within the extracorporeal circuit as required. Instead, when initiating the dialysis treatment, LVN1 was noted to infuse the recirculated normal saline into the patient. Review of the Optiflux dialyzer manufacturer’s instructions titled, “Instructions for Use,” dated 07/23, revealed, “Do not infuse the recirculated saline prime into the patient. Discard the recirculated saline and fill the entire extracorporeal circuit with fresh saline prior to connecting to the patient. The volume of fresh saline used to fill the extracorporeal circuit should be equal to the volume of the dialyzer and blood tubing set in use.” Review of the facility’s policy titled, “Initiation of Dialysis using the Fresenius 2008 Series Dialysis Delivery Systems,” last revised 10/2021, indicated “Open the clamp on the arterial line and flush for 25 seconds (approximately 50 ml (milliliters) of saline) through the arterial line ...unclamp venous line, turn blood pump on and flush 250 ml of normal saline into priming container ... this flushes the dialyzer and blood lines with fresh saline prior to treatment initiation.” An interview with the Facility Administrator on 01/19/24 at 3:30 PM verified that the staff were expected to discard the existing recirculated saline prime and to fill the entire extracorporeal circuit with fresh saline prior to connecting to the patient.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 35561 Based on interview, medical record review, and policy review, the facility failed to ensure patient target weight or estimated dry weight (what the patient would weigh if “dry,” meaning without excess fluid accumulation) was achieved during each dialysis treatment for three of five records reviewed. (Patient (P)1, P4, P5). This failure had the potential to place the patient at risk for serious medical complications related to removal of too little or too much fluid during the treatment, and could affect all 48 in-center dialysis patients receiving treatment at the facility. Findings include: 1.Review of P1’s most current treatment sheets found in the medical record dated from 12/26/23 through 01/17/24, titled “Treatment Details Report” under the section titled, “Post Treatment Weight” revealed the following for five of nine treatments: a. Treatment Details Report on 12/26/23 documented a target weight of 60.0 kilogram ( kg). The pretreatment weight was documented as “65.0 kg.” The post treatment weight was documented as “63.0 kg” The difference from target weight was 3.0 kg (6.6 pounds (lbs.). There was no documentation of the nurse or physician being notified or interventions initiated when P1’s post dialysis weight was 6.6 lbs. higher than the target weight ordered by the physician in the dialysis plan of care. b. Treatment Details Report on 12/28/23 documented a target weight of 60.0 kg. The pretreatment weight was documented as “65.3 kg.” The post treatment weight was documented as “63.4 kg” The difference from target weight was 3.4 kg (7.5 lbs.). There was no documentation of the nurse or physician being notified or interventions initiated when P1’s post dialysis weight was 7.5 lbs. higher than the target weight ordered by the physician in the dialysis plan of care. c. Treatment Details Report on 12/30/23 documented a target weight of 61.0 kg. The pretreatment weight was documented as “65.0 kg.” The post treatment weight was documented as “63.7 kg.” The difference from target weight was 2.7 kg (6.0 lbs.). There was no documentation of the nurse or physician being notified or interventions initiated when P1’s post dialysis weight was 6.0 lbs. higher than the target weight ordered by the physician in the dialysis plan of care. d. Treatment Details Report on 01/02/24 documented a target weight of 61.0 kg. The pretreatment weight was documented as “65.6 kg.” The post treatment weight was documented as “63.9 kg.” The difference from target weight was 2.9 kg (6.4 lbs.). There was no documentation of the nurse or physician being notified or interventions initiated when P1’s post dialysis weight was 6.4 lbs. higher than the target weight ordered by the physician in the dialysis plan of care. e. Treatment Details Report on 01/04/24 documented a target weight of 61.0 kg. The pretreatment weight was documented as “65.1 kg.” The post treatment weight was documented as “63.5 kg.” The difference from target weight was 2.5 kg (5.5 lbs.). There was no documentation of the nurse or physician being notified or interventions initiated when P1’s post dialysis weight was 6.4 lbs. higher than the target weight ordered by the physician in the dialysis plan of care. 2. Review of P4’s most current treatment sheets found in the medical record dated from 12/26/23 through 01/17/24, titled “Treatment Details Report” under the section titled, “Post Treatment Weight”” revealed one of nine treatments as follows: a. Treatment Details Report on 12/30/23 documented a target weight of 57.5 kg. Previous post treatment weight on 01/28/23 was “56.9.” The pretreatment weight on 12/30/23 was documented as “43.4 kg.” The post treatment weight was documented as “42.5 kg” The difference from target weight was 15.0 kg (33.1 lbs.). There was no documentation that the LVN1 (Licensed Vocational Nurse (LVN)1) verified the patient’s weight pre dialysis to ensure accuracy and enable correct calculation of ultrafiltration (fluid removal) for the treatment. There was no documentation of the RN (Registered Nurse (RN) being notified by the LVN1 of this large discrepancy in P4’s weights. 3. Review of P5’s most current treatment sheets found in the medical record dated from 12/26/23 through 01/17/24, titled “Treatment Details Report” under the section titled, “Post Treatment Weight” revealed the following for four of nine treatments: a. Treatment Details Report on 12/26/23 documented a target weight of 54.5 kg. The pretreatment weight was documented as “59.4 kg.” The post treatment weight was documented as “57.1 kg,” The difference from target weight was 2.6 kg (5.7 lbs.). There was no documentation of the nurse or physician being notified or interventions initiated when P5’s post dialysis weight was 5.7 lbs. higher than the target weight ordered by the physician in the dialysis plan of care. b. Treatment Details Report on 12/28/23 documented a target weight of 54.5 kg. The pretreatment weight was documented as “59.4 kg.” The post treatment weight was documented as “56.2 kg.” The difference from target weight was 1.7 kg (3.7 lbs.). There was no documentation of the nurse or physician being notified or interventions initiated when P5’s post dialysis weight was 3.7 lbs. higher than the target weight ordered by the physician in the dialysis plan of care. c. Treatment Details Report on 01/02/24 documented a target weight of 54.5 kg. The pretreatment weight was documented as “59.4 kg.” The post treatment weight was documented as “56.5 kg.” The difference from target weight was 2.0 kg (4.4 lbs.). There was no documentation of the nurse or physician being notified or interventions initiated when P5’s post dialysis weight was 3.7 lbs. higher than the target weight ordered by the physician in the dialysis plan of care. d. Treatment Details Report on 01/10/24 documented a target weight of 55.5 kg. The pretreatment weight was documented as “59.6 kg.” The post treatment weight was documented as “56.8 kg” The difference from target weight was 1.3 kg (2.9 lbs.). There was no documentation of the nurse or physician being notified or interventions initiated when P5’s post dialysis weight was 2.9 lbs. higher than the target weight ordered by the physician in the dialysis plan of care. During an interview on 01/19/24 at 3:30 PM the Facility Administrator confirmed the above findings. The Facility Administrator stated the Patient Care Technician’s (PCT) and the LVN should have reported each failure to achieve the target weight to the Registered Nurse (RN) and documented it in the treatment record. Review of the facility’s policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” last revised 10/23, revealed “Abnormal Findings: The following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record ... Post-Treatment: If patient is above or below 1 kg (kilogram) from the target weight.”