Dci Center

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 48749 Based on observation, record review, and interview, the facility staff failed to complete the “Emergency Evacuation Kit checklist” weekly. The staff failed to follow the facility’s “Emergency Evacuation Kit” policy. Findings include: A review of the Emergency Evacuation Kit Checklist logs for the months of August, September, and October 2024 revealed that the Emergency Kit was not checked by staff every week of each month. A review of the facility’s “Emergency Evacuation Kit” policy dated 01/19/2023 revealed, “Purpose: To have available, in a convenient location, the supplies needed to remove needles, dress needle sites, and flush and cap indwelling venous catheters when an emergency evacuation of the Dialysis Clinic is necessary. 2. The staff will be responsible for ensuring supplies are available and not expired on a weekly basis.” An interview was conducted with Staff #1 on the afternoon of 10/04/2024. Staff #1 stated, “We have only been checking the kits once a month. The policy states weekly.” Staff #1 confirmed that the Emergency Evacuation Kits have been checked by staff once a month.”

“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: 48749 Based on observation, record review, and staff interview, the facility staff failed to monitor and provide a sanitary environment to minimize the transmission of infectious agents within 3 (Sterile Supply, In-Center Treatment area, and Medication Room) of 3 areas in the dialysis center. Also, the facility staff failed to follow the facility’s policy, “Post Dialysis Machine Care and Disinfection”. This deficient practice had the likelihood to cause harm to patients, staff members, and the public by increasing the risk of transmission of infectious agents within the facility. During a tour of the facility on 11/04/2024 at 12:30 PM, the surveyor observed the following infection control issues in the in-center treatment area, storage room, and medication room. Findings include: STORAGE ROOM: The surveyor observed an accumulation of: * dust on the container lids of the boxes storing sterile patient supplies. * papers and dust on a supply cart. * an unknown dried white substance on a supply cart and a calculator. * dust and debris on a supply cart. * rust on the wheel bolts on the supply cart. * an unknown dried white substance on a cart holding vinegar bottles. There was an unknown dried white substance on the outside of the vinegar bottles and the lids. IN-CENTER TREATMENT AREA: The surveyor observed: * an accumulation of rust and an unknown dried green substance on the wheels of a patient privacy screen. * an accumulation of dust and debris on the door and the bottom of the laboratory refrigerator. * an accumulation of lint and debris on the blood pressure cuffs. * two bag 500 milliter bags of 5% dextrose expired with a date of June 2024 in the treatment floor crash cart. * an accumulation of dust on the suction machine and top of the crash cart. * a urinal and patient thermometers sitting next to a clean handwashing sink. * a fly swatter sitting on the counter near sterile patient supplies. * an unknown dried white substance on the exterior of an oxygen concentrator (a medical device that uses room air, removes nitrogen, and delivers a higher oxygen concentration). * a nasal cannula in a basket with a battery, pens, and nail files. * a build-up of dust on the base of the patient Hoyer lift (equipment that allows a person to be lifted and transferred with a minimum of physical effort). * an accumulation of dust on the chairs at the nurse’s station. * an accumulation of dust in the corner behind a chase wall. MEDICATION ROOM: The surveyor observed an accumulation of: * dust in the drawers and cabinets. There was an open sterile syringe loose in a drawer. * dust inside and on top of the medication refrigerator. * dust and cardboard particles on the patient nutrition cart. “External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust.” (AAM1 ST46-Section 5.2 Receiving items).” A review of the facility’s “Post Dialysis Machine Care and Disinfection” policy dated 01/19/2023 revealed the following: “PURPOSE: To provide guidance for routine disinfection of items in the hemodialysis unit. SUPPORTIVE DATA: Failures in environmental cleaning and disinfection have led to the transmission of bloodborne pathogens (e.g., hepatitis B virus) and other infections from one patient to another in hemodialysis units. Proper cleaning and disinfection of environmental surfaces (including patient chairs or bed surfaces, dialysis equipment surfaces, adjacent tables, and work surfaces) must be performed between patient uses to prevent transmission of dangerous pathogens. In hemodialysis units, cleaning and disinfection procedures during patient changeover are particularly prone to error and contribute to risk of cross-contamination if correct procedures are not observed (CMS V122). For visible blood, the intermediate-level disinfection protocol must be followed, which requires the area be immediately cleaned with a cloth soaked with tuberculocidal disinfectant or 1:100 dilution of bleach (300-600 mg/L free chlorine), following the manufacturer’s direction for contact time. Gloves must be worn, and the cloth placed into a leakproof container. After cleaning up all visible blood, a disinfectant must be applied a second time using a new cloth or towel. No patient should be at the station during this time (CMS V122). 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 and station. The CDC defines a “dirty” area as an area where there is a potential for contamination with blood or body fluids and areas where contaminated or “used” supplies, equipment, blood supplies or biohazard containers are stored or handled (CMS V113). Users should establish a procedure for regular disinfection of the machine supply line (the line between the outlet from the water distribution system) and the back of the dialysis machine; this hose should be disinfected at the same frequency as the water distribution loop is disinfected, i.e., monthly (CMS V220). Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient (CMS V 116). After use, all equipment and supplies must be considered as potentially blood-contaminated, and should be separated, handled with caution, and either disinfected or discarded (CMS V116).” An interview with Staff #1 on 10/05/2024 at 2:50 PM confirmed the infection control and safety issues found in the in-center treatment area, storage room, and medication room.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility’s direct care staff failed to ensure that 4 (Patient # 8, # 9, # 10, # 11) of 4 patients receiving hemodialysis treatment washed their access sites prior to treatment. The facility staff failed to follow the facility policy, “Patient Assessments: Pre-Dialysis”. Proper washing of the hemodialysis access site can reduce infection risks. During a tour of the facility’s in-center treatment area on 10/05/2024 at 11:30 AM with Staff # 3, the surveyor observed 4 patients (Patient # 8, # 9, # 10, # 11) entering the facility’s in-center treatment area. The patients were instructed to weigh in prior to treatment. After weighing in, the patients were instructed to their treatment chairs. The patients were not instructed to stop at the sink, located next to the weight station, to wash their dialysis access sites. A review of the facility’s policy, “Patient Assessments: Pre-Dialysis” with a date of 01/19/2023 revealed, “PURPOSE: To obtain baseline information relative to the patient’s physical and/or mental status in order to determine the appropriate interventions necessary to achieve an adequate and safe dialysis treatment ... POLICY: The pre-dialysis assessment must be documented on the hemodialysis flowsheet or in Darwin Direct prior to the start of the dialysis treatment. A licensed nurse must complete the evaluation ... PROCEDURE STEPS: 1. Greet the patient 2. Escort patient to the scale and weigh. Record weight on flowsheet or in Darwin Direct. 3. Instruct the patient to wash access area with an antimicrobial soap prior to disinfecting. KEY POINT: To aid in decreasing microbial count on skin ....” An interview was conducted with Staff # 3 on 11/05/2024 at 11:30 AM. Staff # 3 acknowledged there needed to be reinforcement with the staff members regarding the washing of hemodialysis access sites.”

“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: 48653 Based on observation, record review, and staff interview, the facility’s direct care staff failed to ensure infectious waste was properly discarded in 1 (Patient # 10) of 1 patient encounter observed. During a tour of the facility’s in-center treatment area on 11/05/2024 at 11:05 AM, the surveyor observed Staff # 11 (Dialysis Technician) replace a 1000 ml (milliliter) bag of Normal Saline 0.9 % Intravenous (IV) fluid at Station # 15 where Patient # 10 was receiving treatment. When Staff # 11 replaced the bag of Normal Saline 0.9%, the patient’s blood backed up into the used bag of Normal Saline 0.9% solution. The used bag was empty, and the patient’s blood filled the bag up to approximately 150 ml (milliliters). Staff # 11 then discarded the intravenous fluid bag into the sink labeled, “dirty”. The patient’s blood was draining into the facility’s sink labeled “dirty”. Staff # 11 did not discard the patient’s blood into the appropriate biohazard bin which was designated for infectious and hazardous waste. According to “Texas Health and Human Services Waste Disposals of Non-Sharps” with a date of 01/04/2021, “Non-sharp disposable items saturated with blood or body fluids (i.e., fluid can be poured or squeezed from the item or fluid is dripping from the item) should be discarded into biohazard bags that are puncture-resistant, leak-proof, and labeled with a biohazard symbol or red in color.” During an interview with Staff # 1 and # 3 on 11/05/2024 at 2:45 PM, Staff # 1 and # 3 acknowledged that the dialysis technician had disposed of the patient’s blood improperly.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 48653 Based on record review and staff interview, the facility staff failed to ensure 1 (Patient # 7) of 47 in-center hemodialysis patients received the complete Engerix vaccine series (Hepatitis B vaccine). The facility staff failed to follow the facility policy, “Hepatitis B Management Protocol”. This deficient practice had the likelihood of increasing the patient’s risk of contracting the Hepatitis B virus due to the administration of an incomplete vaccine series. A review of the facility’s Hepatitis B report (printed 11/04/2024) with Staff # 1 (Nurse Manager) revealed, Patient # 7 had a Hepatitis B Surface Antibody (HepBsAb) of less than 3.5 and a negative Hepatitis B Core Antibody (HepBcAb) on 07/02/2024. The patient received dose # 1 of the Engerix vaccine on 07/04/2024. There was no further Engerix vaccine administration after dose # 1. Patient # 7 was considered susceptible to the Hepatitis B virus and the facility staff did not complete the vaccine series. According to the facility’s Hepatitis B Management Protocol, the patient should have received 3 more doses of the Engerix vaccine. A review of the facility’s Hepatitis B Management Protocol dated 06/01/2014 revealed, 1. The goal of the protocol is to monitor Hepatitis B and to provide patients with Hepatitis B immunization based on CDC guidelines. 2. Definitions: a. HepBsAb: Hepatitis B Surface Antibody b. HepBcAb: Hepatitis B Code Antibody c. HepBsAg: Hepatitis B Surface Antigen d. VS#1: Vaccine Series # 1 e. VS#2: Vaccine Series # 2 f. DNC: Did not convert after vaccine series 3. For patients new to DCI and patients not dialyzed in DCI clinics for more than 12 months, draw HepBsAg, HepBsAb, and HepBcAb during the first two treatments/visits. 4. If HepBsAg is positive (for new patient or for established patient in course of dialysis treatment) and patient has no chronic Hepatitis B infection record in the Problem List dialyze patient in isolation, stop vaccination (if in progress) and repeat HepBsAg monthly. After two consecutive months with HepBsAg negative stop isolation and draw HepBsAb. 5. If HepBsAg is positive (for new patient or for established patient in the course of dialysis treatment) and patient has chronic Hepatitis B infection record in the Problem List dialyze the patient in isolation. Repeat HepBsAg in 12 months. 6. If both HepBsAg and HepBcAb are positive, patient developed antibody as a result of infection. Patient no longer requires HepBsAg and HepBcAb testing. 7. If HepBsAg is negative, HepBsAg is negative and HepBcAb is positive, report patient to physician, consider HepBcAb, IGG, and IGM testing. 8. If HepBsAb is positive and HepBcAb is negative (for new patient) or HepBsAb is positive (for established patient), repeat HepBsAb in 12 months. 9. If HepBsAb is negative, patient has no prior history of HepBsAb positive results, and patient has no prior vaccination history, start VS#1, draw HepBaAg monthly, and draw HepBsAb in 2 months after VS#1 completed. 10. If HepBsAb measured after VS#1 is negative, start VS#2, draw HepBsAg monthly, and draw HepBsAb in 2 months after VS # 2 is completed. 11. If HepBsAb measured after VS#2 is negative, declare patient DNC and continue HepBaAg monthly. 12. If HepBsAb is negative, patient has no prior history of HepBsAb positive results, and patient has well documented prior vaccination history, continue vaccination as described in rules (9-11) 13. If HepBsAb is negative, patient has prior history of HepBsAb positive results, declare patient as lost antibody, test HepBsAg monthly, administer Booster Shoot, and repeat HepBsAb with next monthly blood draw but not earlier than 3 weeks after the booster shot. If after booster HepBsAb is positive, stop monthly HepBsAg testing. If after booster, HepBsAb is negative, continue monthly HepBsAg testing. Repeat HepBsAb in 12 months. 14. If vaccine is contraindicated, stop vaccination, and continue HepBsAg monthly. 15. If patient refused vaccination, stop vaccination, and continue HepBsAg monthly. If patient was in the middle of vaccine series test, HepBsAb in 2 months after last vaccine administration. 16. Administer VS#1 and VS#2 as four shots of Engerix-B 40mcg IM during 6 months period of time; the second shot in 4 weeks after the first shot, the third shot in 4 weeks after the second shot, the fourth shot in 18 weeks after the third. Vaccine shot can be postponed up to 2 weeks to avoid drawing monthly HepBsAg within 2 weeks from the vaccination date. 17. HepBsAb and HepBsAg testing will be scheduled with Monthly Chemistry ...” During an interview with Staff # 1 (Nurse Manager) on 11/05/2024 at 9:45 AM, Staff # 1 confirmed the patient did not receive a complete Engerix vaccine series and stated, “I am not sure what happened because the computer should have automatically ordered the vaccine after the first dose. I do not run the report and review it monthly”.”

“RO-MONITOR/ALARM/PREVENT UNSAFE H20 USE CFR(s): 494.40(a) 5.2.7 Reverse osmosis: alarm/prevent use of unsafe water Refer to RD62:2001, 4.3.7 Reverse osmosis: Reverse osmosis devices shall be equipped with on-line monitors that allow determination of rejection rates and product water conductivity. The product water conductivity monitor should activate audible and visual alarms when the product water conductivity exceeds the preset alarm limit. The audible alarm must be audible in the patient care area when reverse osmosis is the last chemical purification process in the water treatment system. Monitors that measure resistivity or TDS may be used in place of conductivity monitors. 6.2.7 Reverse osmosis: Reverse osmosis systems should be monitored daily using continuous-reading monitors that measure product water conductivity (or total dissolved solids (TDS)). 5.2.7 Reverse osmosis: Refer to RD62:2001, 4.3.7 Reverse osmosis: When a reverse osmosis system is the last chemical purification process in the water treatment system, it [should] include a means to prevent patient exposure to unsafe product water, such as diversion of the product water to drain, in the event of a product water conductivity or rejection alarm. This Standard is not met as evidenced by: 48749 Based on observation, record review, and interview, the facility’s staff failed to report to biomedical staff, readings that fell outside of the facility’s set range for its water treatment system. The facility’s biomedical staff did not correct the abnormal ranges on the water treatment system. The facility staff failed to follow its “Daily Water Treatment Monitoring” policy. Findings include: A review of the facility’s “Water System Logs” for August, September, and October 2024 revealed that the staff documented out-of-range readings for the Softener Delta (a device that removes minerals from water to prevent hard water scale) and the Carbon Worker Delta (a device that absorbs or traps polluted molecules in the water system). There was no documentation provided by the facility to show that the abnormal ranges were reported to the Biomed staff or that the Biomed staff addressed the abnormal ranges. Further review of the “Water Systems Logs” revealed: “Softener Delta ranges from 0-12 pounds per square inch (PSI). Carbon Worker Delta ranges from 0-12 PSI. August: Facility staff documented on the Water System Log, 08/02: Softener Delta: -2, Carbon Worker Delta: -2 08/03: Softener Delta: -2 08/15: Softener Delta: -2, Carbon Worker Delta: -2 08/16: Softener Delta: -2 08/19: Softener Delta: -2 08/21: Softener Delta: -2, Carbon Worker Delta: -4 08/22: Softener Delta: -2, Carbon Worker Delta: -2 08/24: Softener Delta: -2, Carbon Worker Delta: -2 08/27: Softener Delta: -2 08/29: Softener Delta: -2 September: Facility staff documented on the Water System Log, 09/02: Softener Delta: -2 09/12: Softener Delta: -2, Carbon Worker Delta: -2 09/13: Softener Delta: -2 09/14: Softener Delta: -2, Carbon Worker Delta: -2 09/16: Softener Delta: -2, Carbon Worker Delta: -2 09/21: Softener Delta: -2 October: Facility staff documented on the Water System Log, 10/01: Softener Delta: -2 10/03: Carbon Worker Delta: -2 10/05: Softener Delta: -2, Carbon Worker Delta: -2 10/07: Carbon Worker Delta: -2 10/15: Softener Delta: -2 10/16: Softener Delta: -2 10/22: Carbon Worker Delta: -6 A review of the facility’s “Daily Water Treatment Monitoring” policy revealed: “Purpose: Ensure proper operation of the Water Treatment System and its components that will provide AAMI Standard Quality Water for Hemodialysis Treatments. Pressure drop across filters can be used to determine when the filter is retaining particulate matter to the point that the filter will no longer allow the required water flow without excessive reduction in pressure at the outlet of the filter. A marked decrease in pressure drop without a corresponding decrease flow rate may indicate a loss of filter integrity. Policy: 1. Monitoring water systems: Acceptable parameters and location descriptions are defined on the Water Systems log in the Technical Module. Verify the RO is in “Normal Operating Mode” and that the RO has run for a minimum of 15 minutes before performing any testing. All pressure readings, flow readings, and testing are documented daily on the Water System Log, and the data entered into the Technical Module. If a reading is out of range, a work order must be completed for the out-of-range results so its repair can be documented and tracked.” An interview with Staff #8 was conducted on 10/04/2024 at 3:15 PM. Staff #8 reported “Sometimes the staff would tell me about the numbers and I review the logs for the RO. I just go into the water room, tap the gauge, and the numbers come up. The gauges have been sticking. I will have to put in a work order to have the gauges replaced.” Staff #8 confirmed the abnormal findings on the facility’s Water System Log.”

“ACID BULK STORAGE TANKS-SAFETY CONTROLS CFR(s): 494.40(a) 5.4 Concentrate preparation 5.4.3 Bulk storage tanks (acid concentrate): safety controls Procedures should be in place to control the transfer of the acid concentrate from the delivery container to the storage tank to prevent the inadvertent mixing of different concentrate formulations. If possible, the tank and associated plumbing should form an integral system to prevent contamination of the acid concentrate. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility staff failed to ensure that the acid storage tank and acid mixer did not contain contaminated acid solution. This deficient practice had the likelihood to cause harm to all patients receiving exposed contaminated acid through the loop at the chairside through the dialysis machine at the facility. Findings include: On a tour of the water room on 11/04/2024 at 1:10 PM, observed there was a white crystal substance build-up around the acid housing connection tubing on top of the acid storage tank. Observed drippings of white substance down the side of the 2 K acid storage tank and the connections. There was a large amount of build-up of white crystals around the 2 K acid tank edges. Also, observed dried acid (a white substance) on the wall connections next to the acid storage tank and white splatter down the wall. There were dried crystal acid build-up on all the connections around both acid storage tanks and the acid mixer. The outlet valves at the bottom of the acid mixer had a moderate amount of dried white crystals. An interview with Staff #8 on 11/04/2024 at 1:20 PM confirmed there was a large amount of acid (white substance) build-up drippings above the acid storage tank housing and the connection valve outlets. There was a large amount of white crystals (acid) splattered down the wall behind the acid storage tank. Staff #8 confirmed that the acid mixer valve outlets were leaking acid.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 29191 Based on record review and interview, the facility staff failed to ensure the acid mixer was labeled to identify what solution was in the acid mixer. This deficient practice had the likelihood of causing harm by mixing the wrong mixture of acid for the dialysis patients. Findings include: During a tour of the water room on 11/04/2024 at 1:10 PM the surveyor observed a full tank of solution in the acid mixer. There was no label indicating what the solution was in the acid mixer. The surveyor asked Bio-medical technician #8 what was in the acid mixer. Staff #8 stated, “I don’t know. There should be a label on the tank saying what is in the acid tank”. A review of the policy titled; “Acid Concentrate Mixing, Transferring, and rinsing of the Rockwall Mixer” dated 03/12/2019 revealed the following: “5.4.3 Bulk storage tanks (acid concentrate) Procedures should be in place to control the transfer of the acid concentrate from the delivery container to the storage tank to prevent the inadvertent mixing of different concentrate formulations. If possible, the tank and associated plumbing should form an integral system to prevent contamination of the acid concentrate. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly.” An interview with Staff #8 on 11/04/2023 at 1:10 PM confirmed the acid tank was not labeled as required so that staff would know what type of solution was in the acid mixer.”

“ACID CONC DIST-CONC LABELED & COLOR-CODED RED CFR(s): 494.40(a) 5.5.3 Acid concentrate distribution systems: labeled & color-coded red Acid concentrate delivery piping should be labeled and color-coded red at the point of use (at the jug filling station or the dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. If the acid system remains intact, no rinsing or disinfection is necessary. More than one type of acid concentrate may be delivered, and each line should clearly indicate the type of acid concentrate it contains. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility’s staff failed to ensure that the dialysis stations’ wall boxes (acid dispensing outlets) had no leaks and were properly cleaned. Also, the facility’s staff did not follow the policy, “Post Dialysis Machine Care and Disinfection” for cleaning the wall boxes. This deficient practice had the likelihood of causing contamination and evaporation in the wall boxes. Findings include: A tour of the in-center treatment area on 11/04/2024 at 1:30 PM observed that all 16 wall boxes had dried crusted white sediment in the outlet boxes and splattered down the wall and around the acid outlet connection hoses. The surveyor asked who was responsible for cleaning the wall boxes. Staff #17 stated, “The staff are responsible for cleaning the wall boxes at the end of each day”. A review of the CDC guidelines related to dialysis wall boxes revealed the following: “Dialysis wall boxes are frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water and dispose of waste products. There are several infection prevention and control issues unique to wall boxes. They can become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients, a vulnerable group at high risk of infection. Thus, wall boxes need to be cleaned, disinfected, and properly maintained to decrease the risk of patient infections.” A review of the facility policy titled; “Post Dialysis Machine Care and Disinfection” dated 01/19/2023 revealed the following: “PURPOSE: To provide guidance for routine disinfection of items in the hemodialysis unit. 5. Chase/water boxes will be cleaned at a scheduled interval per facility protocol. All connectors will be kept free of acid and bicarbonate buildup.” An interview with Staff #17 on 11/04/2024 at 4:00 PM confirmed the acid outlets and wall boxes had dried crusted white sediment in all 16 of the in-center stations’ wall boxes.”

“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: 48749 Based on observation, record review, and interview, the facility staff failed to calibrate 2 Myron L D-6 meters for out-of-range pH (potential of hydrogen, acidity or basicity) and Conductivity (a measure of the total ionic content) results. Also, the facility staff failed to document pH and Conductivity results from the meter to the log. The facility failed to follow its “Myron L D-6 Meter Disinfection, Calibration, Use and Storage” policy. These deficient findings had the likelihood to cause harm to all patients receiving dialysis treatment at the facility by failing to ensure the Myron L D-6 meters were calibrated and within the pH and conductivity ranges. Findings include: A review of the Myron L D-6 meter logs for August, September, and October 2024 revealed the following: “pH range:6.96-7.04 Conductivity range:13.86-14.14 A review of the Myron L D-6 meter log for August 2024 had abnormal ranges for the following days: Meter #1 08/01/2024 pH-7.1 08/05/2024 pH-7.1 08/10/2024 pH-7.1 08/12/2024 Conductivity-13.8 08/20/2024 pH-7.1 08/21/2024 pH-7.1 08/27/2024 pH-6.9 08/29/2024 pH-7.1 Meter #2 08/07/2024 Conductivity-14.1 08/10/2024 pH-7.1 08/16/2024 pH-6.9 08/17/2024 pH-6.9 08/20/2024 pH-6.9 08/21/2024 pH-6.9 08/24/2024 pH-6.9 08/29/2024 pH-6.9 A review of the Myron L D-6 meter log for September 2024 had abnormal ranges for the following days: Meter #1 09/05/2024 Conductivity-14.1 09/11/2024 pH-7.1 09/13/2024 pH-7.1 09/18/2024 pH-7.1 09/24/2024 pH-7.1 09/25/2024 pH-6.9 09/28/2024 pH-7.1 Meter #2 09/10/2024 pH-6.9 09/12/2024 pH-6.9 09/13/2024 pH-6.8 09/18/2024 pH-6.9 09/25/2024 Conductivity-13.8 09/26/2024 pH-6.9 09/28/2024 pH-6.8 A review of the Myron L D-6 meter log for October 2024 had abnormal ranges for the following days: Meter #1 10/01/2024 pH-7.1 10/08/2024 pH-6.9 10/09/2024 pH-7.1 10/11/2024 pH-7.1 10/16/2024 pH-7.1 10/24/2024 pH-7.1 10/25/2024 Conductivity-14.1 10/26/2024 pH-6.9 10/30/2024 pH-7.1, Conductivity-14.1 10/31/2024 pH-6.9 Meter #2 10/01/2024 pH-6.9 10/09/2024 pH-6.9, Conductivity-14.1 10/10/2024 pH-6.9 10/11/2024 pH-6.8 10/16/2024 pH-6.9 10/17/2024 pH-7.1, Conductivity-14.1 10/22/2024 pH-6.9 10/24/2024 pH-6.9 10/30/2024 Conductivity-14.1” A review of the facility’s “Myron L D-6 Meter Disinfection, Calibration, Use, and Storage” policy dated 08/21/2024 revealed: “PURPOSE: To assure the Myron L D6 Meter is properly verified, calibrated, and disinfected prior to use. To assure that the dialysis machine’s conductivity, pH, and temperature are accurate when compared to an independent meter. POLICY: 1. The meter will be verified against 14.0 mS conductivity and 7.0 pH standard solutions daily prior to use, and/or whenever inaccurate readings are suspected or documented on the “Daily Dialysate Meter Log” sheet.Conductivity should read 14 mS ± .14; pH should read 7 ± .04. The meter will be calibrated when the conductivity or pH are out of range. 2. Each dialysis machine’s conductivity, pH, and temperature must be tested before starting each dialysis treatment and documented on the flow sheet. * Gambro and BBraun machines: The Myron L D6 meter’s conductivity should read within ± 0.3 of the machines displayed conductivity. * Fresenius machines: The Myron L 06 meter’s conductivity should read within± 0.3 of the machines TCD AND ±0.3 of the displayed conductivity. (It is not necessary to compare the machines TCD to the displayed conductivity). 3. Conductivity must read between 13.86 and 14.14 mS. Document reading in dialysate meter log. Calibration is required if result is outside range. See Meter Calibration section.” An interview with Staff #1 was conducted on the afternoon of 11/05/2024. Staff #1 reported “I spoke with the staff member who reported rounding the numbers on the log. The staff were documenting to the tenth and not the exact result numbers.” Staff #1 confirmed the staff did not calibrate the meters or document the exact meter results of the Myron L D-6 meter logs.”

“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: 29191 Based on observation and staff interviews, the facility staff failed to ensure the emergency pull cord was accessible for a patient in the event they fell on the floor in the lobby. The emergency pull cord should be within 6 inches of the floor. This deficient practice has the likelihood of causing harm to patients in an emergency. Findings include: Upon entering the facility’s lobby on 11/04/2024 at 12:00 PM, the emergency pull cord was blocked by an end table with the lobby phone and magazines. The emergency cord was blocked and not accessible for a patient to call for help in the event the patient fell on the floor. The end table remained in front of the call cord for two days until the surveyor informed the Area Operations Director the emergency cord was blocked from the patients. An interview with Staff # 16 (Area Operations Director) on 10/05/2024 at 11:00 AM confirmed the pull cord was blocked by the end table and was not accessible for a patient to call for help in the event the patient fell on the floor.”

“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: 48749 Based on observation, record review, and staff interview, the facility staff failed to ensure quality control solutions (a liquid made up of water, glucose, and buffers used to test the function of the meter and test strips) for the glucometers (a small device that measures how much sugar is in a blood sample) were dated when opened. The facility staff failed to follow the “Use of the Assure Platinum Glucometer and the Embrace Glucometer” policy. Findings include: During a tour of the facility treatment floor on 10/04/2024 at 12:30 PM, the surveyor observed an open box of quality control solutions. There was no date of opening, expiration date, or staff initials written on the quality control solution bottles. The surveyor was unable to determine when the control solutions were opened. A review of the facility’s “Use of the Assure Platinum Glucometer and the Embrace Glucometer” policy. dated 02/16/2023 revealed the following: “6. Verify expiration date and date opened on Level 1 and Level 2 control solutions. Vials expire 90 days after opening.” An interview was conducted with Staff #1 on the afternoon of 10/05/2024. Staff #1 confirmed that the quality control solutions were not labeled with an opening date or the staff member’s initials.”

“PR-PTS INFORMED OF RIGHTS WHEN BEGIN TX CFR(s): 494.70 The dialysis facility must inform patients (or their representatives) of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights. This Standard is not met as evidenced by: 48653 Based on record review and staff interview, the facility staff failed to ensure a properly executed informed consent was obtained prior to initiating hemodialysis treatment on 4 (Patient # 2, # 5, # 6, # 12) of 5 patient medical records reviewed. Also, the facility staff failed to follow the facility policy, “Informed Consent for Procedures”. A review of patient medical records on 11/04/2024 revealed the following, Patient # 2 A review of Patient # 2’s medical records revealed Staff # 2 (Licensed Medical Social Worker) obtained and witnessed the patient’s informed consent for dialysis treatment on 4/9/2024 at 9:15 AM. There was no signature from a clinical staff member (Registered Nurse) who could have answered clinical questions the patient may have had regarding hemodialysis. There was no provider name or signature on the consent form. It was unknown who the provider was and if that provider had adequately informed and advised the patient prior to the consent form being signed. Patient # 5 A review of Patient # 5’s medical records revealed Staff # 2 (Licensed Medical Social Worker) obtained and witnessed the patient’s informed consent for dialysis treatment on 07/23/2024 at 10:55 AM. There was no signature from a clinical staff member (Registered Nurse) who could have answered clinical questions the patient may have had regarding hemodialysis. There was no provider name or signature on the consent form. It was unknown who the provider was and if that provider had adequately informed and advised the patient prior to the consent form being signed. Patient # 6 A review of Patient # 6’s medical records revealed Staff # 2 (Licensed Medical Social Worker) obtained and witnessed the patient’s informed consent for dialysis treatment on 07/23/2024 at 11:15 AM. There was no signature from a clinical staff member (Registered Nurse) who could have answered clinical questions the patient may have had regarding hemodialysis. There was no provider name or signature on the consent form. It was unknown who the provider was and if that provider had adequately informed and advised the patient prior to the consent form being signed. Patient # 12 A review of Patient # 12’s medical records revealed Staff # 2 (Licensed Medical Social Worker) obtained and witnessed the patient’s informed consent for dialysis treatment on 05/20/2024 at 10:45 AM. There was no signature from a clinical staff member (Registered Nurse) who could have answered clinical questions the patient may have had regarding hemodialysis. There was no provider name or signature on the consent form. It was unknown who the provider was and if that provider had adequately informed and advised the patient prior to the consent form being signed. A review of the facility’s policy, “Informed Consent for Procedures” with a date of 10/01/2014 revealed, “PURPOSE: Provide guidelines for the obtaining a signed ‘Informed Consent’ prior to initiation of special procedures or treatment ... POLICY: 1. A fully completed legal consent form must be signed by the patient or legally responsible party and witnessed by a staff member prior to the performance of the invasive procedures. 2. The provider performing a procedure is responsible for obtaining the informed consent .... 4. The provider will adequately inform and advise their patient about the type of procedure to be done and alternative methods of treatment available, if any. 5. The patient’s name, provider’s name, the procedure to be performed, and the date and time of the consent must be completed prior to the form being signed by the patient. 6. The patient must read the consent form prior to signing, or the consent form must be read to them. 7. The consent will be witnessed only after being signed by the patient or responsible party. 8. In each case, the provider performing the procedure must sign the affirmation prior to performing the procedure. 9. A clinical assistant will ensure the form is properly completed and placed in the patient’s medical record for the protection of the patient and the provider.” An interview was conducted with Staff # 2 on 11/04/2024 at 3:00 PM. Staff # 2 acknowledged that she had been obtaining informed consent for dialysis treatment from the patients and that a clinical staff member (Registered Nurse) should have been witnessing the consent. Also, Staff # 2 acknowledged the facility’s policy was not being followed.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 48653 Based on record review and interview, the Registered Nurse failed to ensure the pre-treatment nursing assessments were completed and documented within one (1) hour of treatment initiation on 2 (Patient # 1 and # 5) of 4 patient medical records reviewed. Also, the Registered Nurse failed to follow the facility policy, “Patient Assessments: Pre-Dialysis”. Findings include: Patient # 1 A review of 2 of 6 treatment sheets for Patient # 1 revealed the Registered Nurse (Staff # 5) did not complete the pre-treatment nursing assessment within one (1) hour of treatment initiation. A review of the treatment sheets dated 10/25/2024 revealed Staff # 5 did not complete the pre-treatment nursing assessment (documented at 11:48 AM) within 1 hour of the initiation of treatment. Treatment began at 10:34 AM. A review of the treatment sheets dated 10/30/2024 revealed Staff # 5 did not complete the pre-treatment nursing assessment (documented at 12:13 PM) within 1 hour of the initiation of treatment. Treatment began at 10:24 AM. Patient # 5 A review of 3 of 6 treatment sheets for Patient # 5 revealed the Registered Nurse (Staff # 5) did not complete the pre-treatment nursing assessment within one (1) hour of treatment initiation. A review of the treatment sheets dated 10/22/2024 revealed Staff # 5 did not complete the pre-treatment nursing assessment (documented at 12:35 PM) within 1 hour of the initiation of treatment. Treatment began at 11:01 AM . A review of the treatment sheets dated 10/24/2024 revealed Staff # 5 did not complete the pre-treatment nursing assessment (documented at 1:45 PM) within 1 hour of the initiation of treatment. Treatment began at 10:31 AM. A review of the treatment sheets dated 11/02/2024 revealed Staff # 5 did not complete the pre-treatment nursing assessment (documented at 3:13 PM) within 1 hour of the initiation of treatment. Treatment began at 10:36 AM. A review of the facility’s policy, “Patient Assessments: Pre-Dialysis” with a date of 01/19/2023 revealed, “PURPOSE: To obtain baseline information relative to the patient’s physical and/or mental status in order to determine the appropriate interventions necessary to achieve an adequate and safe dialysis treatment. POLICY: The pre-dialysis assessment must be documented on the hemodialysis flowsheet or in Darwin Direct prior to the start of the dialysis treatment. A licensed nurse must complete the evaluation ...” An interview was conducted with Staff # 2 on 11/04/2024 at 2:30 PM. Staff # 2 acknowledged the Staff were not documenting the pre-treatment nursing assessments within 1 hour of treatment initiation. Also, the staff did not follow the facility policy.”

“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: 48653 Based on record review and staff interview, the facility staff failed to follow the physician’s prescribed orders for blood flow rate (BFR) in 3 (Patient #2, # 5, # 6) of 4 medical records reviewed. This deficient practice had the likelihood to harm patients by not following the physician’s dialysis orders which could negatively impact the effectiveness and adequacy of the dialysis treatment for all 47 in-center hemodialysis patients receiving care at this facility. Findings include: Patient # 2 A review of the treatment sheet dated 11/02/2024 revealed the following, “Dialysis Prescription: DFR (dialysis flow rate): 600ml/min (milliliters per minute) BFR (blood flow rate): 400 ml/min” The patient’s set BFR (blood flow rate) throughout treatment was “300 ml/min”. There was no documented order from the physician to adjust the BFR for this treatment date. Patient # 5 A review of the treatment sheet dated 10/22/2024 revealed the following, “Dialysis Prescription: DFR: 600ml/min BFR: 400 ml/min” The patient’s set BFR throughout treatment was “300 ml/min”. There was no documented order from the physician to adjust the BFR for this treatment date. A review of the treatment sheet dated 10/29/2024 revealed the following, “Dialysis Prescription: DFR: 600ml/min BFR: 250 ml/min” The patient’s set BFR throughout treatment was “400 ml/min”. There was no documented order from the physician to adjust the BFR for this treatment date. Patient # 6 A review of the treatment sheet dated 10/22/2024 revealed the following, “Dialysis Prescription: DFR: 600ml/min BFR: 350 ml/min” The patient’s set BFR throughout treatment was between “300-340”. There was no documented order from the physician to adjust the BFR for this treatment date. A review of the treatment sheet dated 10/24/2024 revealed the following, “Dialysis Prescription: DFR: 600ml/min BFR: 350 ml/min” The patient’s set BFR throughout treatment was “300”. There was no documented order from the physician to adjust the BFR for this treatment date. A review of the treatment sheet dated 10/26/2024 revealed the following, “Dialysis Prescription: DFR: 600ml/min BFR: 350 ml/min” The patient’s set BFR throughout treatment was “300”. There was no documented order from the physician to adjust the BFR for this treatment date. An interview with Staff # 3 on 11/04/2024 at 2:40 PM confirmed the facility staff was not consistently following the physician’s order for blood flow rate.”