Davita Lawton Dialysis

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 34689 Based on observation and interview, the facility failed to ensure that clean areas were clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment, citing one of two facility areas (in-center hemodialysis treatment area) in that, the facility did not clearly separate clean areas from contaminated areas where used supplies and equipment were handled and/or stored. Findings included: A review of the facility’s Infection Control for Dialysis Facilities Policy dated April 2023, included, “Facility Hygiene...16. Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment were handled...” On 12/22/2023 at 9:55 AM, during a tour of the facility’s treatment area, the surveyor observed 2 - 4 face shields stored on top of the two counters mixed with clean supplies such as Normal Saline bags, dialyzers, arteriovenous fistula needles, and alcohol prep pads. There was an opened bottle without a cap of the residual chlorine strips, without date, time, and initial of the staff who opened the bottle, stored on top of the counter with clean supplies. On 12/22/2023 at 10:00 AM, the facility administrator (Personnel #1) confirmed the above findings.”

“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: 34689 Based on observation, interview, and record review, the facility’s direct care staff failed to label medications that included date, time, and initials of the staff who prepared and administered the medication, citing one of one patient (patient #3). This practice placed all patients at risk for medication administration error and cross contamination. Findings included: A review of the facility’s Infection Control for Dialysis Facilities Policy dated April 2023, included, “Supplies...8. Supplies will be stored in a manner that maintains their integrity...b. Expiration date and package integrity will be verified prior to use...d. Anytime the integrity of a package with or without an expiration date is in question...must be disposed of and not used...” On 12/22/2023 at 10:35 AM, the surveyor observed dialysis machine #3 connected to a Naturalyte dialysate 2.0 Potassium (K+) 3.0 Calcium jug did not include a date, time, and initials of the staff that opened the jug, at dialysis station #9, where Patient #3 dialyzed. On 12/22/2023 at 10:40 AM, personnel #9 confirmed the above findings. When asked why did the dialysate jug did not include a date, time, and initials of the staff that opened the jug, she stated, we were going to throw that at the end of the day anyway.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 34689 Based on observation, interview, and record review, the facility failed to ensure that infection control practices and techniques were followed and maintained to prevent risk to patient health and safety, as evidenced by: Findings included: 1. The facility failed to ensure that three of four facility areas (Peritoneal Dialysis area, water/treatment storage area, and water/treatment system area) provided and monitored a sanitary environment to minimize the transmission of infectious agents within and between the units or other public areas. Cross refer to V tag: V 111. 2. The facility failed to ensure one of one personnel (Personnel #7), wore disposable gloves appropriately and performed handwashing between change of gloves during the provision of patient care and/or when going from a “dirty” area or task to a “clean” area or task. This practice placed all patients at risk for cross-contamination and/or infection. Cross refer to V tag: V 113. 3. The facility failed to monitor and implement biohazard and infection control policies and activities within the dialysis unit, citing three of three personnel (Personnel #6, #7, and #8) in that the facility personnel did not apply the safety protector of the used arteriovenous fistula needles per the manufacturer’s instructions and facility procedure. This practice placed all patients and staff at risk for accidental needlesticks and cross - contamination and/or infection. Cross refer to V tag: V 121. 4. The facility failed to ensure that appropriate infection control measures to prevent intravascular catheter related infections were practiced and followed, citing one of one facility staff (Registered Nurse (RN) (personnel #7). This practice placed all patients at the facility at risk for infection. Cross refer to V tag: V 147.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 34689 Based on record review and interview, facility failed to ensure facility’s staff knowledge, competency training and skills were sustained in operation and/or testing and documented governing body approval of the major upgrade to the facility’s dialysis machines. This practice had the potential risk of inaccurate detection of chlorine/ chloramine in the water used to provide hemodialysis treatment to all patients who received hemodialysis treatment in the facility, as evidenced by: Findings included: 1. The facility failed to ensure that the manufacturer’s instructions regarding the use of an independent method to check for conductivity and measure for approximate pH before starting treatments of patients were followed, in that a) upgrade to the facility’s dialysis machines were done without documented governing body approval and b) there was no documented in-services to changes in procedures of conductivity testing, prior to use of the new upgraded dialysis machines. This practice placed all patients in the facility at risk for injuries related to improper dialyzable and/or connecting the wrong concentrates in dialysate could harm the patient. Cross refer to V tag: V 250. 2. The facility failed to ensure staff were appropriately trained and/or have an updated skills that are sustained, one of one Licensed Practical Nurse (LPN) (personnel #10). These findings have the potential to cause harm to all patients at the facility by the failure to train and evaluate the staff on their knowledge and understanding of the facility water treatment system skills and/or machine equipment procedures and skills. Cross refer to V tag: V 260.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 34689 Based on observation, record review, and interview, the medical director failed to ensure that all policies and procedures relative to patient care, infection control, and safety were adhered to by all individuals who treat patient in the facility, as evidenced by: Findings included: 1. The facility failed to ensure all staff and patients of the facility participated in fire drills, citing two of two dialysis modalities (In-Center hemodialysis and Peritoneal Dialysis Program) in that there were no documented facility fire drills. This practice placed all patients and staff’s safety at risk during an emergency in the facility. Cross refer to E tag: E 0036. 2. The facility failed to ensure patient #5 was able to reach the emergency call light during her dialysis treatment in the isolation room. Cross refer to V tag: V 402. 3. The facility failed to ensure that all facility areas, two of two facility areas (water treatment system area and in-center hemodialysis treatment area), were cleaned and maintained in accordance with the manufacturer’s recommendations. Cross refert to V tag: V 403. 4. The facility failed to evaluate the appropriateness of the dialysis prescription, citing three of three dialysis patients (Patients #7, #8, and #9) who did not have physician’s orders for the provision of care. Cross refer to V tag: V 503. 5. The facility failed to ensure a complete assessment of a patient’s dialysis access, citing two of two patients (Patients #7 and #12), in that patients’ peritoneal dialysis catheter site and vascular access assessment was not observed and documented. Cross refer to V tag: V 511.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 34689 Based on observation, record review, and interview, the Governing Body failed to ensure to address overall management of the facility and demonstrate responsibility for the operation of the facility, including fiscal management, and staff training as evidenced by: Findings included: 1. The governing body failed to demonstrate responsibility ensuring that all members of the facility’s staff were qualified to perform the duties and responsibilities assigned to them, citing one of two Peritoneal Dialysis staff (Personnel #2) in that personnel #2’s personnel file did not include Peritoneal Dialysis competency and skills training. Cross refer to V tag: V 685. 2. The facility failed to ensure five of five facility personnel (personnel #7, #10, #12, and #13) personnel files included an orientation specific to the facility. Cross refer to V tag: V 760.”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 34689 Based on record review and interview, the facility failed to ensure all staff and patients of the facility participated in fire drills, citing two of two dialysis modalities (In-Center hemodialysis and Peritoneal Dialysis Program) in that there were no documented facility fire drills. This practice placed all patients and staff’s safety at risk during an emergency in the facility. Findings included: A review of the facility’s Facility Emergency Management Plan Policy dated April 2023, included, “...Fire Safety Preparedness...1. Facility Administrator (FA) or designee, is reponsible to...b. Conduct and review quarterly fire safety...” 1. In - Center Hemodialysis facility showed no documented fire drills for 2022 and 2023 for facility staff and patients. - A Drill Evaluation Form dated 03/03/23 Drill facilitator: Personnel #19 corrective Action Plan: Everyone did very well made sure staff could verbalize all aspects of drill. Facility Administrator (FA) Personnel #19. 11/08/2023 at 10:44 AM, interviewed Patient #3, been here for 2 years and 2 months. When asked if had participated on fire drills while he was on his treatment, he stated, “no fire drills.” 11/08/2023 at 11:00 AM, when Patient #5 was asked if she had participated in a fire drill while she was in the facility or during her dialysis treatment, she stated, no fire drills. 11:02 AM Confirmed findings the patient care technician (PCT) (Personnel #6). 2. Peritoneal Dialysis (PD) facility modality showed no documented fire drills done for 2022 and 2023 for facility staff and patients. On 11/09/2023 at 2:00 PM the group facility administrator (GFA) (Personnel #4) confirmed the above findings. When Personnel #4 was asked to provide the facility’s fire drill reports for the in-center and peritoneal dialysis modalities, she stated, we could not find any fire drill reports.”

“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: 34689 Based on observation, record review, and interview, the facility failed to ensure that three of four facility areas (Peritoneal Dialysis area, water/treatment storage area, and water/treatment system area) provided and monitored a sanitary environment to minimize the transmission of infectious agents within and between the units or other public areas. Findings included: A review of the facility’s Infection Control For Dialysis Facilities Policy dated April 2023, included, “...Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment...Supplies...8. Supplies will be stored in a manner that maintains their integrity...b. Expiration date and package integrity will be verified prior to use...Disinfection...12. Cleaning and/or disinfection of equipment and work surfaces...” 1. Peritoneal Dialysis (PD) area: On 11/08/2023 at 9:50 AM, the surveyor observed the cabinets under the sink inside the PD training rooms #1 and #2 were dirty and hinges on the cabinet doors with corroded dark orange crusting. PD room training #1 cabinet with brownish sediments and pieces of brownish powder like sawdust sediments. PD room training #2 cabinet with black non-moving insect. The dialysis treatment recliner when the sides were opened, the metal parts were corroded with dark orange crusting. On 11/08/2023 at 10:00 AM, the PD Registered Nurse (RN) (Personnel #2) confirmed the above findings. 2. Water/treatment area storage area: On 11/08/2023 at 10:20 AM, there were approximately 10 plastic dusty dialysate containers not inverted and stored on the top shelf of the wire storage unit. The floor to the storage area was cluttered with pieces of paper, alcohol prep pads, and pieces of tape. There were 3 -4 blue mops with handles stored under the wire storage unit by the wall. 3. Water treatment system area: There was a yellow tubing approximately 2 - 3 yards in length wound together on the ground by the wall of the water treatment system pipes beside the blending pump and the multimedia tank. There were thick brownish stains on the wall beside the multimedia tank. On 11/08/2023 at 10:25 AM, the facility administrator (FA) (Personnel #1) confirmed the above findings.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 34689 Based on observation, record review, and interview, the facility failed to ensure one of one personnel (Personnel #7), wore disposable gloves appropriately and performed handwashing between change of gloves during the provision of patient care and/or when going from a “dirty” area or task to a “clean” area or task. This practice placed all patients at risk for cross-contamination and/or infection. Findings included: A review of the facility’s Infection Control For Dialysis Facilities Policy dated April 2023, included, “...Purpose: To minimize the spread of infections or bloodborne pathogens in the facility environment...Hand Hygiene...1. All teammates...will perform hand hygiene...b. prior to gloving and immediately after removal of gloves...d. after patient and dialysis delivery system contact...g. before touching clean areas such as supplies, supply cart and chairside keyboard...Personal Protective Equipment (PPE) (i.e., gown, gloves...)...7. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station...a. Gloves should be changed when...ii. when going from a “dirty” area or task to a “clean” area or task...iii. When moving from a contaminated body site to a clean body site of the same patient...” 1. On 11/08/2023 at 12:30 PM, the surveyor observed the Registered Nurse (RN) (Personnel #7) prepared, assessed, and cleansed Patient #6’s right central venous catheter (CVC). Personnel #7 applied and wrapped gloves to 2 - 3 fingers, removed the gloves and reapplied gloves on one hand, did not use hand sanitizer and worked on the dialysis machine and on the computer keyboard with the same gloves. Personnel #7 changed gloves without using the hand sanitizer in between glove changes and provision of care. On 11/08/2023 at 12:42 PM, Personnel #7 confirmed the above findings. 2. On 11/09/2023 at 2:20 PM, the surveyor observed Personnel #7 discontinued Patient #11’s dialysis treatment, removed arteriovenous fistula (AVF) needles from upper left arm, discarded AVF needle in the sharps container and pushed the AVF needle with her fingers, inside the opening of the sharps container, and pulled the other AVF needle off the AVF site, discarded the AVF needle on the opening of the sharps container, pushed the AVF needle inside the container with her fingers. Personnel #7 did not change her gloves after she pushed the AVF needle the opening of the sharps container and proceeded to remove the second AVF needle from the vascular site. On 11/09/2023 at 2:40 PM, Personnel #7 confirmed the above findings.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [The facility must demonstrate that it follows standard infection control precautions by implementing-] (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 34689 Based on observation, record review, and interview, the facility failed to monitor and implement biohazard and infection control policies and activities within the dialysis unit, citing three of three personnel (Personnel #6, #7, and #8) in that the facility personnel did not apply the safety protector of the used arteriovenous fistula needles per the manufacturer’s instructions and facility procedure. This practice placed all patients and staff at risk for accidental needlesticks and cross - contamination and/or infection. Findings included: A review of Nipro SafeTouch Tulip Safety AV Fistula Needle Set with Anti-Stick Needle Protector procedure, included, “...Removal of AVF from patient and engagement of Tulip needle protector...5. To withdraw AVF from patient, pull on tubing while pushing...needle protector forward completely covering the needle...” A review of the facility’s Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles Procedure dated April 2023, included, “...7. Remove needle...following the manufacturer’s instructions. Slide safety device over needle tip and apply pressure to insertion site...rationale...safety devices protect patients and teammates...8. With safety device engaged, dispose of safety fistula needle in the sharps container...” During a tour of the facility on 11/08/2023, the surveyor observed the following: 1. At 10:30 AM, the Licensed Practical Nurse (LPN) (Personnel #8) pulled the arteriovenous fistula (AVF) needle from Patient #2’s left lower forearm vascular site with personnel #8’s right hand, tried to engage and apply the AVF needle’s safety protector beside Patient #2’s left arm and simultaneously held Patient #2’s AVF vascular site with her left fingers. The used AVF needle had blood dripped from the needle to the white pad on the chairside table. On 11/08/2023 at 10:38 AM, personnel #8 confirmed the above findings and stated, that she does not normally have problem with the safety. 2. At 10:40 AM observed the patient care technician (PCT) (Personnel #6) removed and pulled 2 AVF needles from Patient #3’s right lower forearm AVF without applying the AVF needles’ safety. Personnel #6 manipulated and tried to engage the safety protector of the AVF needle beside Patient #3’s arm, with his right hand while his left fingers applied pressure on patient’s AVF vascular site and placed the used AVF needle on top of patient’s arm to secure and steady the safety protector. Blood dripped from the used AVF needles to the white pad on top of the chairside table. On 11/08/2023 at 10:43 AM, Personnel #6 confirmed the above findings. 3. On 11/09/2023 at 2:20 PM, the surveyor observed the Registered Nurse (RN) (Personnel #7) discontinued Patient #11’s dialysis treatment, removed AVF needles from the upper left arm, discarded AVF needle in the sharps container and pushed the AVF needle with her fingers, inside the opening of the sharps container, and pulled the other AVF needle off the AVF site, discarded the AVF needle on the opening of the sharps container, pushed the AVF needle inside the container with her fingers. On 11/09/2023 at 2:40 PM, Personnel #7 confirmed the 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: 34689 Based on observation, record review, and interview, the facility failed to ensure that appropriate infection control measures to prevent intravascular catheter related infections were practiced and followed, citing one of one facility staff (Registered Nurse (RN) (personnel #7). This practice placed all patients at the facility at risk for infection. Findings included: A review of the facility’s Central Venous Catheter (CVC) With Clearguard Hemodialysis (HD) Antimicrobial End Caps Procedure Policy dated October 2023, included, “...Notes: Use Dialysis Precautions and aseptic technique throughout procedure...8...using aseptic technique, clean exit site with...swab...apply to the CVC exit site in a back and forth pattern, using gently friction progressing from the insertion site to the periphery using both sides of the swab. If site is not free of exudates, repeat this step with new swab...” On 11/08/2023 at 12:30 PM, the surveyor observed Personnel #7 used swab stick on CVC site, started cleaning right on the CVC puncture site and the skin around the CVC. Personnel #7 used the swab stick, repeated the procedure and started on the CVC puncture site. On 11/08/2023 at 12:42 PM, Personnel #7 confirmed the above findings.”

“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: 34689 Based on record review and interview, the facility failed to ensure that the manufacturer’s instructions regarding the use of an independent method to check for conductivity and measure for approximate pH before starting treatments of patients were followed, in that a) upgrade to the facility’s dialysis machines were done without documented governing body approval and b) there was no documented in-services to changes in procedures of conductivity testing, prior to use of the new upgraded dialysis machines. This practice placed all patients in the facility at risk for injuries related to improper dialyzable and/or connecting the wrong concentrates in dialysate could harm the patient. Findings included: A review of the facility’s Machine Start Up and Priming A Single Use Dialyzer Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Streamline Blood Lines for First Shift of the Day Policy dated October 2022, included, “...If Using the Fresenius 2008 T or T BlueStar Model, no manual conductivity is required unless required by State Regulations...Procedure...40. If using Fresenius 2008 T or T BlueStar model, no manual conductivity is required...If the final dialysate conductivity is not within range do not initiate treatment...” On 11/08/2023 at 11:20 AM, when the Licensed Practical Nurse (LPN) (Personnel #8) was asked where the Phoenix Meters or the Myron L conductivity meters were, she stated, we don’t have them anymore. We just check the pH with these test strips since about last year, we were told not to do the conductivity anymore. When asked what the reason was for not checking conductivity, she stated, I do not know. On 11/08/2023 at 11:40 AM, the facility administrator (Personnel #3) confirmed the above findings and stated the facility had their machines upgraded to do independent conductivity. On 11/09/2023 at 10:00 AM, the surveyor conducted an interview with the facility’s Biomed (Personnel #15) and the Biomedical Operations Manager (BOM) (Personnel #16). When Personnel #16 was asked the reason for facility staff not checking conductivity prior to patients’ dialysis treatments, he stated, we have all 2008 T dialysis machines in this facility upgraded to perform independent conductivity and if there’s an issue with the conductivity, the dialysis machine will not pass the test and will not be able to use for the dialysis treatment. When asked when did facility’s dialysis machines upgrade happen, he stated, 06/14/2022. When asked for the governing body meeting to approve the upgrade for all the facility’s dialysis machines and for the in-services to facility staff of the upgrade and the change in facility procedure regarding pH and conductivity, he stated, the facility administrator will have that. At 11:00 AM, the surveyor requested the group facility administrator (GFA) (Personnel #4) and Personnel #16 for the governing body meeting minutes to upgrade the facility’s dialysis machines and the facility staff in-services for the facility staff of the upgrade and change of procedures for pH and conductivity testing. At 1:00 PM, Personnel #4 confirmed the above findings. When asked where the governing body meeting minutes to upgrade the facility’s 2008 T dialysis machines and in-services to the facility staff to change the facility’s procedure for checking the conductivity prior to patients’ treatments, she stated, we could not find the governing body meeting minutes and not able to find any in-services to facility staff regarding the procedure change for checking the conductivity.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 34689 Based on observation, record review, and interview, the facility failed to ensure staff were appropriately trained and/or have an updated skills that are sustained, one of one Licensed Practical Nurse (LPN) (personnel #10). These findings have the potential to cause harm to all patients at the facility by the failure to train and evaluate the staff on their knowledge and understanding of the facility water treatment system skills and/or machine equipment procedures and skills. Findings included: A review of the facility’s Initial and Annual Training Requirements for Water and Dialysate Concentrate Policy dated October 2023, included, “...Policy...1...require the operators of the water/dialysate system equipment to be trained...4...require that each teammate performing the procedures listed below...monitoring and testing of dialysate quality water to include total chlorine testing...” On 11/08/2023 at 9:05 AM, the surveyor and the facility administrator (FA) (Personnel #3) observed the Licensed Practical Nurse (LPN) (Personnel #10) demonstrated water testing for chlorine/chloramines. When asked how long she had done water testing for this facility, she stated, since April 2023. -When Personnel #10 was asked which tank did the water sample come from to do the chlorine/chloramines testing she did, she stated, I don’t know.” When asked to review and look at the facility’s water treatment system and find out where the sample from the water testing came from, she stated, that she did not know. -When asked how the cold water from the city, water from the hot water tank get the correct temperature to blend and run through the water treatment system, she stated, she didn’t know. On 11/08/2023 at 9:25 AM, the FA confirmed the above findings, and stated Personnel #10 did not know the water treatment system functions.”

“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: 34689 Based on observation and interview, the facility failed to ensure patient #5 was able to reach the emergency call light during her dialysis treatment in the isolation room. Findings included: On 11/08/2023 at 11:00 AM, the surveyor observed Patient # 5 dialyzed in dialysis station #12 (isolation room) alone and observed the call light hung on the wall behind patient #5’s right side. When patient was asked if this was the station she dialyzed at, she stated, yes, mostly in this room. When asked if and when she needed assistance or help from the facility staff, how did she call for the facility staff, she stated, I would yell or wave someone in. When asked if she knew there was a call light to use to call for help, she stated, she did not know. On 11/08/2023 at 11:05 AM, Personnel #6 confirmed the above findings.”

“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: 34689 Based on observation, record review, and interview, the facility failed to ensure that all facility areas, two of two facility areas (water treatment system area and in-center hemodialysis treatment area), were cleaned and maintained in accordance with the manufacturer’s recommendations. Findings included: On 11/08/2023, the surveyor conducted a tour of the facility with the facility administrators (Personnel #1 and #3) and observed the following: 1. Water treatment system area: At 10:20 AM, the hot water tank with a square metal pan approximately the size of 36 inches by 36 inches and was approximately half filled with standing water and metal pan corroded with dark orange discoloration. There was a continuous dripping leak from the pipe of the hot water tank. On 11/08/2023 at 10:22 AM, Personnel #1 confirmed the above findings. When asked how long had the drip and water been in the metal pan, she stated, she did not know. 2. In-center hemodialysis treatment area: At 11:10 AM, machine #12 at dialysis station #4 had standing water from the left side and the front of the machine. On 11/08/2023 at 11:15 AM, the patient care technician (PCT) (Personnel #6) confirmed the above findings. When asked where the water came from, he stated, on the wall connection located at the back of the patient’s recliner at dialysis station #4. On 11/08/2023 at 11:30 AM, the facility administrator (FA) (Personnel #3) mopped the floor at dialysis station #4. At 12:40 PM observed pooling and standing water on the side of Machine #12 at dialysis station #4. Personnel #3 stated that she already cleaned and dried the floor before.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 34689 Based on observation, record review and interview, the facility failed to evaluate the appropriateness of the dialysis prescription, citing three of three dialysis patients (Patients #7, #8, and #9) who did not have physician’s orders for the provision of care. Findings included: A review of the facility’s Physician Orders For Patient Care Policy dated April 2018, included, “...Definition: An order is a diagnostic or therapeutic patient care directive from...credentialed practitioner...Policy: General...4. Orders must be received prior to the delivery of any treatment or service ordered...10. All orders must be entered into the Electronic Medical Record...” 1. Patient #7: Peritoneal Dialysis (PD) Patient Training Treatment Form showed: -Dated 04/04/2022, included, “...patient (pt) arrived ambulatory. pt had PD catheter placed last Monday...PD catheter flushed with 100 millimeter (ml) 1.5% Dianeal...Personnel #22 (RN)...” A review of Patient #7’s clinic records showed no documented orders for peritoneal dialysis catheter (PD) first flush post PD catheter placement, what and how much solution to use for the first flush procedure from Patient #7’s physicin (Personnel #11). On 11/08/2023 at 3:15 PM, Personnel #2 confirmed the above findings. 2. Patient #8: Patient Notes dated 03/15/2023, included, “...patient (pt) presents today for dressing change and flush of peritoneal dialysis (pd) catheter...(Personnel #18) Registered Nurse (RN)...” A review of Patient #8’s clinic records showed no documented orders for peritoneal dialysis catheter (PD) first flush post PD catheter placement, what and how much solution to use for the first flush procedure from Patient #8’s physicin (Personnel #11). On 11/08/2023 at 3:05 PM, the peritoneal dialysis (PD) RN (Personnel #2) confirmed the above findings. 3. Patient #9: On 11/08/2023 at 9:10 AM, when the facility administrator (FA) (Personnel #1) was asked if the facility has any current COVID positive patients, she stated, yes, we have one patient, patient #9 and he is dialyzing in the isolation room. A review of Patient #9’s clinic records showed the following: Treatment Details Report: - Dated 11/03/2023, included, “...machine setup...station #10...pre treatment vitals...Blood Pressure (BP) 107/52 Heart rate (HR) 79...fluid calculations...ordered target weight 79.0 kilogram (kg)...pre weight 79.1 kg...6:28 AM BP 143/59 HR 69...treatment started...(Personnel #8) Licensed Practical Nurse (LPN)...9:26 AM BP 140/95 HR 62...treatment terminated...(Personnel #9) Patient Care Technician (PCT)...” - Dated 11/07/2023, included, “...machine setup...station #12...pre treatment vital signs...Blood Pressure (BP) 121/54...Heart rate (HR) 88...fluid calculations: ordered target weight 79,0 kilograms (kg)...pre weight 82.6 kg...5:50 AM...treatment started BP 168/66...HR 72...10:03 AM BP 117/61...HR 64...treatment terminated...(Personnel #10) Licensed Practical Nurse (LPN)...” Comprehensive Encounter dated 11/07/2023, included, “...patient status...Has COVID PNA - getting isolation hemodialysis (HD)...(Personnel #17) Medical Doctor (MD)...” On 11/09/2023 at 11:00 AM, when the group facility administrator (GFA) was asked when and how did facility staff know of Patient #9’s COVID positive status, she stated, Patient #9 called the facility on 11/04/2023 and reported that he was COVID positive. When asked where did Patient #9 wait for his dialysis treatment to start, she stated, he waited in his car and he was called to come in when the station was ready. There was no documented evidence facility staff called and notified Patient #9’s Nephrologist (Personnel #17) of Patient #9’s positive COVID test. There was no documented orders from Patient #1’s Nephrologist (Personnel #17) to dialyze Patient #9 in the isolation room and/or to follow the facility’s COVID protocol when Patient #9 is treated in the facility. On 11/09/2023 at 11:30 AM, the surveyor conducted a telephone interview with Patient #9’s physician (Personnel 17) and when asked if and when did facility staff informed him of Patient #9’s COVID positive status, he stated, nobody called him to let him know that Patient #9 has COVID and that he found out when he saw Patient #9 at the clinic on 11/07/2023. On 11/09/2023 at 11:40 AM, Personnel #4 (GFA) confirmed the above findings.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 34689 Based on interview and record review, the facility failed to ensure a complete assessment of a patient’s dialysis access, citing two of two patients (Patients #7 and #12), in that patients’ peritoneal dialysis catheter site and vascular access assessment was not observed and documented. Findings included: A review of the facility’s Routine Support Service Policy dated April 2023, included, “...Policy...2. The Peritoneal Dialysis Registered Nurse (RN) must conduct the clinic visit...5. Clinic visits may include the following...Data collection and assessment of...exit site status...” A review of the facility’s CWOW-Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment Policy dated April 2021, included, “...Policy...1. Patient data...will be obtained and documented by the patient care technician (PCT)...a. Data collection includes...vi. Vascular access status...” 1. Patient #12: On 11/08/2023 at 11:05 AM, the surveyor observed the patient care technician (PCT) (Personnel #6), prepared Patient #12 to start dialysis treatment with the Registered Nurse (RN) (Personnel #7) at the chairside. Personnel #6 cleansed Patient #12’s upper left arm arteriovenous fistula (AVF) site and cannulated AVF X2 without listening for bruit and/or assessing for thrill. Personnel #6 did not have his stethoscope with him during his preparation for the treatment. On 11/08/2023 at 11:07 AM, the Registered Nurse (RN) (Personnel #7) confirmed the above findings. 2. Patient #7: Patient Note dated 05/02/2023, included, “...patient (pt) presented to clinic today unstable gait...some abdominal pain...RN took bp and was 67/42...physician spoke with pt and spouse...called for ambulance...” A review of clinical records showed no documented assessment of Patient #7’s PD catheter site. On 11/09/2023 at 9:00 AM, the RN (Personnel #3) confirmed the above findings.”

“PQ-SELF/HOME TRG RN-12 MO RN+3 MO MODALITY CFR(s): 494.140(b)(2) (2) Self-care and home dialysis training nurse. The nurse responsible for self-care and/or home care training must- (i) Be a registered nurse; and (ii) Have at least 12 months experience in providing nursing care and an additional 3 months of experience in the specific modality for which the nurse will provide self-care training. This Standard is not met as evidenced by: 34689 Based on record review and interview, the governing body failed to demonstrate responsibility ensuring that all members of the facility’s staff were qualified to perform the duties and responsibilities assigned to them, citing one of two Peritoneal Dialysis staff (Personnel #2) in that personnel #2’s personnel file did not include Peritoneal Dialysis competency and skills training. Findings included: A review of Peritoneal Dialysis (PD) Patients #7 and #8’s clinic records showed Personnel #2 assessed and provided PD patients care and education regarding PD fluid restriction, infection prevention and appropriate dialysate fluid selection for fluid overload during monthly clinic visits on and off 07/06/2023 - 10/13/2023 visits for Patient #7 and on and off 05/22/2023 - 10/30/2023 visits for Patient #8. A review of the facility’s Peritoneal Dialysis (PD) Registered Nurse (RN) (Personnel #2)’s personnel file showed no documented PD knowledge examination and PD competency skills. On 11/09/2023, the group facility administrator (GFA) (Personnel #4) confirmed the above findings.”

“GOV-GB RESP FOR STAFF ORIENTATION CFR(s): 494.180(b)(3) The governing body or designated person responsible must ensure that- (3) All staff, including the medical director, have appropriate orientation to the facility and their work responsibilities; This Standard is not met as evidenced by: 34689 Based on record review and interview, the facility failed to ensure five of five facility personnel (personnel #7, #10, #12, and #13) personnel files included an orientation specific to the facility. Findings included: A review of personnel files for the Registered Nurse (RN) (Personnel #7), Patient Care Technician (PCT) (Personnel #9), Licensed Practical Nurse (LPN) (Personnel #10), the Social Worker (SW) (Personnel #12), and the Dietitian (RD) (Personnel #13) showed no documented orientation to the facility. On 11/09/2023 at 2:15 PM, the group facility administrator (Personnel #4) confirmed the above findings.”