032639 Estrella Mountain Dialysis, LLC (Ara)

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff and providers used gloves and performed hand hygiene appropriately before entering the dialysis station and touching patient equipment and clean supplies which has the potential risk of infection through contact transmission and cross contamination. Findings include: The facility policy titled “G40 Infection Control” requires: “...Gloves are required whenever caring for a patient or touching the patient ’ s equipment or supplies ...Hands are always washed after gloves are removed and between patient contacts, as well as after touching blood, body fluids, secretions, excretions and contaminated items ....” Observation on 07/08/2025 revealed Provider #21 rounding on patients at the facility. Provider #21 approached the patient dialyzing at station #9 and touched the patient’s machine with bare hands. Provider #21 did not perform hand hygiene or don gloves before touching the patient ’ s machine. Provider #21 finished looking at the patient ’ s machine and began to type on the rounding laptop positioned at the patient ’ s chairside. Observation on 07/08/2025 revealed Employee #7 initiate a patient ’ s treatment at station #4. Employee #7 left the station after the patient ’ s blood flow rate was at order, did not remove her dirty gloves, walked to a clean storage area and retrieved two blue hemostat clamps from the clean equipment bin with the dirty gloves, walked back to the dialysis station and placed one clamp on the saline line and used the other clamp to secure the patient ’ s blood lines to the patient ’ s shirt. Employees #1 and 2 confirmed on 07/08/2025 that staff and providers did not follow standard precautions and infection control policy.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) 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. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that that facility failed to ensure: 1. staff discarded dirty tape instead of returning to a clean supply area; 2. staff thoroughly cleaned and disinfected stethoscopes after use; and 3. Staff disinfected Phoenix meters after use at the dialysis station and prior to returning the meter to a clean area. These deficient practices pose an increased risk of infection if staff use dirty and/or contaminated supplies and equipment on patients. Findings include: 1. 2. and 3. The facility policy titled “G40 Infection Control” requires: ’ ...Each center will maintain and clearly label separate ’ clean ’ and ’ dirty ’ work areas. Clean items ...are kept in the designated ’ clean ’ areas ...Reusable supplies will not be shared between patients without being disinfected between each use per the appropriate procedure; this includes blood pressure cuffs and stethoscopes ....” The facility policy titled “G45 Cleaning & Disinfection of Equipment, Supplies & Treatment Area” requires: “...Reusable supplies contaminated with visible blood must be cleaned per this policy and then disinfected, using the bleach/water solution specified in this policy ....” 1. Observation on 07/08/2025, revealed Employee #7 pick up a roll of 2” paper tape that had dropped onto the treatment floor adjacent to the regular and biohazard trash cans. Employee #7 placed the roll of tape back on top of a workstation containing multiple clean patient supplies, equipment, and PPE. 2. Observation on 07/08/2025 revealed Provider #21 use his stethoscope to assess the patient dialyzing at station #9. The provider placed his stethoscope around his neck after use and did not disinfect it before providing care to the next patient. Observation on 07/08/2025 revealed Employee #8 use her stethoscope to assess the patient ’ s vascular access at station #8. Employee #8 placed her stethoscope around her neck after use and did not disinfect it prior to returning the stethoscope to a clean area. Observation on 07/08/2025 revealed Employee #24 use her stethoscope to assess a patient at station #14. Employee #24 used a small 70% isopropyl alcohol pad to clean the diaphragm only on the stethoscope. Observation on 07/08/2025 revealed Employee #7 use her stethoscope to assess a patient at station #4. Employee #7 used a small 70% isopropyl alcohol pad to clean the diaphragm only on the stethoscope. 3. Observation on 07/08/2025 revealed Employee #8 retrieve a phoenix meter and take it to station #8 where a patient was seated and waiting to start dialysis treatment. Employee #8 checked the machine ’ s dialysate pH and conductivity, emptied the waste into the prime bucket, and returned the dirty meter to the clean supply storage area/workstation without disinfecting the equipment. Observation on 07/08/2025 revealed Employee #7 retrieve a phoenix meter and take it to station #5 where a patient was seated and waiting to start dialysis treatment. Employee #7 checked the machine ’ s dialysate pH and conductivity, emptied the waste into the prime bucket, and returned the dirty meter to the clean supply storage area/workstation without disinfecting the equipment. Observation on 07/08/2025 revealed Employee #14 retrieve a phoenix meter and take it to station #12 where a patient was seated and waiting to start dialysis treatment. Employee #14 checked the machine ’ s dialysate pH and conductivity, emptied the waste into the prime bucket, and returned the dirty meter to the clean supply storage area/workstation without disinfecting the equipment. Observation on 07/08/2025 revealed Employee #16 retrieve a phoenix meter and take it to station #7 where a patient was seated and waiting to start dialysis treatment. Employee #16 checked the machine ’ s dialysate pH and conductivity, emptied the waste into the prime bucket, and returned the dirty meter to the clean supply storage area/workstation without disinfecting the equipment. Employees #8 and 16 confirmed on 07/08/2025 that phoenix meters are only cleaned and disinfected at the start of the treatment day and not after being taken into and used in the dialysis station and returned to a clean area. Employees #1 and 2 confirmed on 07/08/2025, that staff did not follow established infection control guidelines for discarding dirty disposable patient supplies and disinfecting stethoscopes and phoenix meters after use.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [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-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff disinfected the entire dialysis station and equipment after use which poses an increased risk of infection to patients through cross contamination and contact transmission of pathogenic organisms. Findings include: The facility policy titled “G45 Cleaning & Disinfection of Equipment, Supplies & Treatment Area” requires: “...equipment, treatment area and work surfaces will be disinfected using a 1:00 bleach/water solution ...All routinely touched reusable equipment and surfaces in each patient ’ s treatment area must be disinfected after each patient ’ s treatment ...This includes, but is not limited to the: ...dialysis machine ...chair ...bedside table ...television ...phone ...counters and wall boxes ....” Observation on 07/08/2025 revealed Employee #8 cleaning and disinfecting station #7. Employee #8 did not use a bleach solution to clean the back or the arm of the television, did not disinfect the hansen hoses on the side of the dialysis machine, or the concentrate tubing on the front of the dialysis machine. Observation on 07/08/2025 revealed Employee #8 cleaning and disinfecting station #8. Employee #8 did not use a bleach solution to clean the back or the arm of the television, did not disinfect the hansen hoses on the side of the dialysis machine, or the concentrate tubing on the front of the dialysis machine. Observation on 07/08/2025 revealed Employee #8 cleaning and disinfecting station #10. Employee #8 did not use a bleach solution to clean the back or the arm of the television, did not disinfect the hansen hoses on the side of the dialysis machine, or the concentrate tubing on the front of the dialysis machine. Employee #2 confirmed on 07/08/2025 that staff did not clean and disinfect all surfaces in the dialysis station or equipment as required by policy.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 37489 Based on document review and interview, it was determined that the facility failed to ensure policy and procedure was implemented for annual tuberculosis (TB) screening for (5) of (7) patients (Patient ’ s #2, 3, 4, 6, and 7). This deficient practice poses the potential risk of the spread of tuberculosis (TB) if preventative measures are not implemented. Findings include: The facility policy titled “Tuberculosis Screening” with an Effective Date of 01/2021 requires “...All patients will be tested upon admission for baseline tuberculin skin test results ...ongoing TB screening for all patients is completed by administering a TB Risk Assessment Questionnaire annually at minimum or:...as required by state or local regulations ...” Patient #2 Patient #2 ’ s medical record review on 07/08/2025 revealed an initial tuberculin skin test (TST) upon admission in 2020. The patient did not have a TB Risk Assessment Questionnaire (RAQ) completed in 2021, 2022, 2023, or 2024. Patient #3 Patient #3 ’ s medical record review on 07/08/2025 revealed an initial TST upon admission in 2020. The patient did not have a TB RAQ completed in 2021, 2022, 2023, or 2024. Patient #4 Patient #4 ’ s medical record review on 07/08/2025 revealed an initial TST upon admission in 2017. The patient did not have a TB RAQ completed in 2018, 2019, 2020, 2021, 2022, 2023, or 2024. Patient #6 Patient #6 ’ s medical record review on 07/08/2025 revealed an initial TST upon admission in 2020. The patient did not have a TB RAQ completed in 2021, 2022, 2023, or 2024. Patient #7 Patient #7 ’ s medical record review on 07/08/2025 revealed an initial TST upon admission in 2021, and a TB Raq completed in 2021. The patient did not have a TB RAQ completed in 2023, or 2024. Employees #1 and 2 confirmed on 07/08/2025 that Patients #2, 3, 4, 6, and 7 received a TB Test on admission and if travelling, but annual patient screening was not performed until this year (2025)”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff were able to verbalize training of policies on chlorine breakthrough procedures which poses a potential risk of harm or death to patients in the event staff do not know what actions to take to protect patients if there is chlorine breakthrough in dialysis water. Findings include: The facility policy titled “Total Chorine Testing” requires: “...The following procedure identifies actions taken when obtaining Total Chlorine and samples: ...GAC - Granular Activated Carbon (Carbon Tank)....If ...A breakthrough is detected after the primary GAC ...Testing must be performed after the secondary GAC tank/bank immediately ...If ...A breakthrough has been confirmed after the post primary GAC ...(and secondary less than 0.1 ppm)...Perform Total Chlorine testing a minimum of every thirty (30) Minutes ...(if) Secondary Carbon Tank/Bank (equal to or greater than 0.1 ppm ...Stop Treatments ....” Observation on 07/08/2025 revealed Employee #8 performing a chlorine test on the dialysate water in the water room. Employee #8 was asked to perform the test, explain the results, and explain what actions would be taken if results were out of range. Employee #8 verbalized retesting the primary carbon tank every 15 minutes after detecting a chlorine breakthrough and notifying leadership. Employee #19 confirmed on 07/08/2025 that staff was not able to verbalize correct procedures in the event of a chlorine breakthrough in dialysis water to include immediate testing of the secondary carbon tank, repeat testing every 30 minutes if the results were within appropriate range on the secondary carbon tank, and/or terminating patient treatments without returning patient ’ s blood if results were out of range on the secondary carbon tank as outlined in the facility policy for chlorine testing and the breakthrough algorithm.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 37489 Based on document review and interview, it was determined that the facility failed to ensure staff followed the hemodialysis treatment orders for prescribed Blood Flow Rate (BFR) for (2) of (6) patients (Patients #5 and 6). This deficient practice poses the potential risk of inadequate dialysis, decreased clearances and hospitalizations if physician orders are not followed. Findings include: The facility policy titled “Monitoring & Documentation of Patient Care During Treatment” requires “...The following must be documented before “starting” the patient ’ s treatment in the electronic documentation system:...Treatment RX ...Orders ... Information that must be entered manually includes ...If the patient ’ s prescription was not met for any reason (A detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation)...” Patient #5 Patient #5 ’ s medical record review on 07/08/2025 revealed a prescribed BFR of 350mL/min. The treatment sheet dated 06/18/2025 revealed the patient ’ s BFR was set to 450mL/min for the entirety of the treatment. No documentation or rationale for the BFR change was documented for the treatment. Patient #6 Patient #6 ’ s medical record review on 07/08/2025 revealed a prescribed BFR of 300mL/min. The treatment sheet dated 07/04/2025 revealed the patient ’ s BFR was set to 350mL/min for the entirety of the treatment. No documentation or rationale for the BFR change was documented for the treatment. Employee #1 confirmed on 07/08/2025 that Patients #5 and 6 did not receive their hemodialysis treatment as prescribed by their nephrologist.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure paper medical records and the electronic medical record for patients was protected from unauthorized access which has the potential risk to violate a patient ’ s rights to privacy of their personally identifiable information and medical condition. Findings include: The policy titled “CMPL-015 Records Retention” requires: “...IRC ’ s records will be stored in a safe and secure manner ...while maintaining confidentiality ...Inactive records may be sent to an off-site records ’ storage facility ....” Observation on 07/06/2025 revealed an unsecured room in the facility that had an open locking medical records cart with stacks of loose medical records, six (6) individual binders with patient ’ s medical records, and three shelves with more than nine (9) more binders of medical records as well as additional loose records. There were stacks of loose paper records placed on a sink counter, two chairs, and a desk. The room was left open and unsecured for several hours. Observation on 07/07/2025 revealed that the unsecured room noted on 07/06/2025 also contained multiple records of patients who had been discharged from the facility. Observation on 07/08/2025 revealed two (2) desktop computers and three (3) rounding laptops in use on the treatment floor. All five computers were in use by staff to access the facility EMR (electronic medical record). Staff left the stations unattended and did not secure or otherwise lock the screen on the monitors to prevent unauthorized visualization and access of patient medical records when they left the area. Employees #1 and 2 confirmed on 07/08/2025 that physical paper records for both current and past patients were left unsecured in the facility and that staff did not lock their computers when unattended to prevent unauthorized access to the medical record.”