Dci - Dialysis Clinic, Inc.

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 35306 Based on policy and procedure reviews, observations, and staff interviews the facility staff failed to ensure an effective infection control program that demonstrated recognition of cross-contamination and potential transmission of bloodborne pathogens in order to decrease the risk of infection to the dialysis facility’s patients’ health and safety. Findings included: A. The facility failed to prevent potential cross-contamination of clean clamps and tourniquets during staff handwashing in 2 of 2 observed clean clamps and tourniquet storage ~ Cross refer to 494.30(a)(1)(i) Infection Control - Standard Tag V0114 B. The facility staff failed to follow infection control standard precautions by failing to wear a mask during access of an AVF/G for initiation of dialysis in 2 of 2 observations (Patient #9, CCHT #1 and Patient #4, CCHT #2) and during discontinuation of an AVF/G for discontinuation of dialysis in 4 of 4 observations and failed to change masks between access of an AVF for initiation of dialysis (Patient #4, CCHT #2) and discontinuation of dialysis with a CVC (Patient #, CCHT #2) in 1 of 2 observations. ~ Cross refer to 494.30(a)(1)(i) Infection Control - Standard Tag V0115 C. The facility staff failed to prevent cross-contamination in 1 of 2 observations of reusable supplies not fully submerged in bleach solution. ~ Cross refer to 494.30(a)(4)(ii) Infection Control - Standard Tag V0122 D. The facility’s leadership failed to demonstrate evidence of continuous monitoring of Infection Control practices within the facility. ~ Cross refer to 494.30(a)(1)(i)(b) (1) Infection Control - Standard Tag V0142 E. The facility staff failed to follow infection control standard precautions by failing to disinfect CVC hubs “vigorously” and “thoroughly with friction” and to ensure a new alcohol pad was used on each hub in 1 of 2 CVC initiations (Patient #5, NM). ~ Cross refer to 494.30(a)(2) Infection Control - Standard Tag V0147”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 35306 Based on review of the facility Quality Assessment and Performance Improvement Proram, Clinical QAPI Workflow algorithm review, QAPI Report review, Action Plan review, QAPI Committee meeting minutes, and staff interviews, it was determined that the the facility failed to have an effective quality program. Findings included: 1. The facility leadership failed to maintain and demonstrate evidence of its QAPI program by failing to ensure QAPI Committee minutes were completed and available for review. ~Cross refer to §494.110 Quality assessment and performance improvement - Standard Tag V0626 1. The facility’s Interdisciplinary Team (IDT) failed to demonstrate evidence of ongoing development, implementation, and monitoring of action plans for Anemia, specifically, for the percentage of patients with Transferrin Saturation (TSAT) 30-50. ~Cross refer to §494.110(a)(2)(iv) Quality assessment and performance improvement - Standard Tag V0632 2. The facility’s Interdisciplinary Team (IDT) failed to demonstrate evidence of ongoing development, implementation, and monitoring of action plans as it related to the high catheter percentage rate for its patient census of hemodialysis patients. ~Cross refer to §494.110(a)(2)(v) Quality assessment and performance improvement - Standard Tag V0633 3. The facility’s Interdisciplinary Team (IDT) failed to demonstrate evidence of analysis, tracking, and monitoring of patient occurrences. ~Cross refer to §494.110(a)(2)(vi) Quality assessment and performance improvement - Standard Tag V0634 4. The facility’s Interdisciplinary Team (IDT) failed to demonstrate evidence of continuous monitoring of Infection Control practices within the facility. ~Cross refer to §494.110(2)(b) Quality assessment and performance improvement - Standard Tag V0638”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 35306 Based on policy and procedure review, QAPI Program review, Action Plan review, QAPI Committee meeting minutes review, Manufacturer Recommendations review, Operatons Manual review, observation, and staff interview, it was determined that the facility’s Medical Director failed to monitor the environment for the safety and care of patients related to Water & Dialysate Quality and Physical Environment, failed to maintain and demonstrate evidence of the facility’s QAPI program by failing to ensure QAPI Committee meeting minutes were completed and available for review, and failed to ensure the facility implemented and maintained an effective Infection Control program, . Findings included: A. The facility staff failed to ensure that acid concentrates stored in 55-gallon drum containers were kept tightly closed to prevent potential contamination during non-use in 1 of 1 observed acid concentrate 55-gallon drums in the acid storage area. ~ Cross refer to §494.40(a) 5.4.3 Water & Dialysate Quality - Standard Tag V0222 B. The facility failed to ensure the routine maintenance was maintained on 2 of 2 oxygen concentrators per manufacturer recommendations. ~ Cross refer to §494.60(a) Physical environment - Standard Tag V0403 C. the facility leadership failed to maintain and demonstrate evidence of its QAPI program by failing to ensure QAPI Committee minutes were completed and available for review. ~ Cross refer to §494.110 Quality assessment and performance improvement - Standard Tag V0626 D. The facility’s Interdisciplinary Team (IDT) failed to demonstrate evidence of continuous monitoring of Infection Control practices within the facility. ~Cross refer to §494.110(2)(b) Quality assessment and performance improvement - Standard Tag V0638”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 35306 Based on review of the Centers for Disease Control and Prevention (CDC) website, personnel files, and facility policy, and staff interview, the facility’s Governing Body failed to ensure staff demonstrate and sustain the skills needed to perform the specific duties of their positions and to serve the complex needs of dialysis patients for 1 of 3 personnel files reviewed (NM). Findings included: 1. The facility’s Governing Body failed to ensure staff demonstrate and sustain the skills needed to perform the specific duties of their positions and to serve the complex needs of dialysis patients for 1 of 3 personnel files reviewed (NM). ~ Cross refer to §494.180(b)(3) Governance - Standard Tag V0760”

“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: 35306 Based on policy review, observation and staff interview, the facility failed to prevent potential cross-contamination of clean clamps and tourniquets during staff handwashing in 2 of 2 observed clean clamps storage (CN and CCHT #1). Findings included: Review on 01/12/2024 revealed there was no facility policy addressing separation of “clean and dirty” equipment. Review on 01/12/2024 of the facility policy titled, “Hand Hygiene DATE ISSUED: February 24, 2017” revealed, “... 10. Stand in front of sink, keeping hands and uniform away from sink surface. If hands touch sink during the hand washing process, repeat the process. The inside of the sink is a contaminated area. Reaching over the sink increases the risk of touching the edge, which is contaminated with organisms that spread easily from hands to faucet and vice versa...” Observation on 01/10/2024 between 1145 to 1530 and on 01/12/2024 between 0950 to 1200 in the patient treatment area revealed one (1) uncovered plastic container containing “clean blood clamps and tourniquets” that was stored on the sink countertop, beside of the facility’s hand washing sink area located in front of the treatment area between Bay A and Bay C. Observation on 01/10/2024 and 01/12/2024 revealed the facility staff washed their hands in the designated “Clean” handwashing sink beside the opened container of clean clamps with potential cross-contamination noted. Interview during the observation on 01/10/2024 with the CN revealed the plastic container of clamps had “always been kept there.” Interview revealed the potential for cross-contamination “makes sense. I’ll make sure we get it moved.” The interview revealed that cross-contamination could occur while washing hands as splattering of water was possible by staff while washing hands. Interview confirmed observation findings. Interview on 01/12/2024 at 1730 with the AOD revealed that there use to be plexiglass separating the sink from the area where the clean clamps were stored after disinfection. Interview revealed the AOD would look into what needed to be done to prevent potential cross-contamination of clean supplies during hand hygiene. Interview confirmed observation findings.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 35306 Based on facility policy review, observations, and staff interview, the facility staff failed to follow infection control standard precautions by failing to wear a mask during access of an AVF/G for initiation of dialysis in 2 of 2 observations (Patient #9, CCHT #1 and Patient #4, CCHT #2) and during discontinuation of an AVF/G for discontinuation of dialysis in 4 of 4 observations and failed to change masks between access of an AVF for initiation of dialysis (Patient #4, CCHT #2) and discontinuation of dialysis with a CVC (Patient #5, CCHT #2) in 1 of 2 observations. Findings included: Review on 01/12/2024 of the facility policy titled, “Universal Precautions, DATE ISSUED: 01/16/2019” revealed, “... Universal precautions apply to blood ... For universal precautions, protective barriers reduce the risk of exposure to blood ... Examples of protective barriers include....masks ... Masks and protective eyewear or face shields should reduce the incidence of contamination of mucous membranes of the mouth, nose, and eyes ... Staff members should wear gown, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis... POLICY ... 4. Use protective barriers to prevent exposure to blood, body fluids containing visible blood, and other fluids to which universal precautions apply. ... 8. Staff will wear personal protective equipment (PPE) appropriate to the anticipated potential occupational exposure. ... 9. Staff will wear PPE during the initiation and termination of dialysis treatment... Facial Protection - Facial shields provide protection for the eyes, nose and mouth. All areas of the face should be covered by whichever method is chosen. 30. Facial coverings may either be full facial shields or a mask used in conjunction with goggles, or prescription eye glasses with side shields. 40. Facial protection is required for all procedures for which there is a chance of splattering or splashing of blood or other body fluids. ... Note: A new mask should always be used for each catheter dressing change or care and it should be discarded following the procedure...” 1.a. Observation on 01/10/2024 at 1145 revealed CCHT #2 accessed Patient #9’s AVG for initiation of dialysis without a mask in conjunction with eyeglasses with side shields per facility policy. Observation revealed CCHT #2 failed to use the facility provided PPE and to follow infection control standard precautions outlined in the facility’s Universal Precautions policy. Interview on 01/10/2024 at 1230 with the CN revealed that staff were no longer required to wear masks, except when accessing CVC for initiation or discontinuation of dialysis. Interview on 01/12/2024 at 1744 with the NM revealed that her expectation would be that staff members would protect themselves from blood splatter and follow policy. Interview revealed the NM was not aware of the requirements outlined in policy and following review shared that a mask should be worn in conjunction with eyeglasses with side shields to prevent potential contamination with bloodborne pathogens. Interview on 01/12/2024 at 1855 with the AOD revealed, “Masks should be worn” anytime there is potential for blood splatter. Observation on 01/12/2024 at 1115 revealed CCHT #2 accessed Patient #4’s AVF for initiation of dialysis without a mask in conjunction with eyeglasses with side shields per facility policy. Observation revealed CCHT #1 failed to use the facility provided PPE and to follow infection control standard precautions outlined in the facility’s Universal Precautions policy. Interview on 01/10/2024 at 1230 with the CN revealed that staff were no longer required to wear masks, except when accessing a CVC for initiation or discontinuation of hemodialysis. Interview on 01/12/2024 at 1254 with CCHT #2 revealed that staff were no longer required to wear masks, except when accessing a CVC for initiation or discontinuation of hemodialysis. Interview revealed CCHT #2 was not aware of the facility’s “Universal Precautions” policy requirements. Interview on 01/12/2024 at 1744 with the NM revealed that her expectation would be that staff members would protect themselves from blood splatter and follow policy. Interview revealed the NM was not aware of the requirements outlined in policy and following review shared that a mask should be worn in conjunction with eyeglasses with side shields to prevent potential contamination with bloodborne pathogens. Interview on 01/12/2024 at 1855 with the AOD revealed, “Masks should be worn” anytime there is potential for blood splatter. 2. Observation on 01/10/2024 at 1200 revealed CCHT #2 accessed Patient #4’s AVF for initiation of dialysis with a black face mask under her chin. Observation revealed CCHT #2 wore the face mask under her chin throughout the course of the day, without changing masks. Observation at 1519 revealed CCHT #2 pulled the black face mask up from under her chin and accessed Patient #8’s CVC for discontinuation of dialysis. Observation revealed a new mask was not used for per the facility’s “Universal Precautions” policy. Interview on 01/12/2024 at 1744 with the NM revealed that a new face mask should be worn when accessing a CVC for initiation or discontinuation of hemodialysis. Interview on 01/12/2024 at 1855 with the AOD revealed, “Face masks should not be under the chin” and that a new face mask should be worn when accessing a CVC for initiation or discontinuation for hemodialysis.”

“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: 35306 Based on facility policy review, observation and interview, the facility staff failed to prevent cross-contamination in 1 of 2 observations of reusable supplies not fully submerged in bleach solution. Findings included: Review on 01/12/2024 of the facility policy titled, “Disinfection of Reusable Supplies in Hospital Services”, no date, revealed “2. All reusable supplies (e.g., holding clamps, hemostats, etc.) will be disinfected after each patient use to prevent the transmission of infectious pathogens ... 4. If the item is water-resistant or can be safely immersed, soak items in 1% solution or manufacturer recommended solution for recommended time for disinfectant...” Observation on 01/12/2024 at 1000 on Side A in the patient treatment area, revealed a lidded, plastic container labeled as 1:10 bleach solution with two (2) tourniquets. Observation revealed the tourniquets were not fully “immersed” in the 1:10 bleach solution. Interview on 01/12/2024 at 1215 with the AOD revealed the tourniquets should be fully submersed in the bleach solution. “We even have a netted cover to lay over top of them to make sure everything is fully submersed [in the bleach solution].” The interview confirmed the observation finding.”

“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: 35306 Based on policy review, “Monthly Nurse Manager Responsibilities” review, “Nursing Monthly Checklist” review, and staff interviews, the facility’s administrative staff failed to demonstrate evidence of monitoring of Infection Control practices within the facility. Findings included: Review on 01/12/2024 of the facility policy titled, “Infection Control Audit - Hospital Services” revised 10/2013 revealed, “... 1. At a minimum of once per quarter, the Nurse Manager or a designated [organization] staff member will audit the Hospital Services program for compliance with infection control guidelines. 2. The Infection Control Audit Tool (Attachment 608 A) will be used to complete the audit of the Hospital Services program. 3 The findings of the audit will be presented by the Nurse Manager at the monthly Quality Management. A plan of correction will be implemented for any areas of deficiency ... PROCEDURE ... 2. Document notes related to areas of non-compliance in the Corrective Action section of the Infection Control Audit Tool. 3. Present the information at the Monthly QAPI meeting and discuss the plan of correction.” Review of “Attachment 608 A - Infection Control Audit Tool” revealed a comprehensive checklist for assessment of compliance to include, “General Infection Control Processes ... Isolation ... Medication ... Staff Compliance ... Patient Compliance ... General Compliance ... Hepatitis Compliance ... Patient Specific Compliance ... Medication Compliance ... Employment Compliance.” Review of the “Monthly Nurse Manager Responsibilities” revealed scheduled duties with the months due marked on the calendar with an “x” duties that were scheduled to be performed. Review of the listed duties revealed, “... 11. Corporate Infection Control Audit every other month (make sure you are able to evaluate each staff member for correct procedures at least once per year - put in QA [Quality Assurance]” were due to be performed every other month beginning in January. Review of monthly assigned duties included, “14. Infection control audits ... 55. Follow up on Action Plans in QAPI to ensure that all areas are being addressed and completed in a timely manner.” Further review of the scheduled NM responsibilities revealed, “Items due... 5 days after QAPI meeting... Infection Control audit, NM responsibilities, and Items to be reviewed from all to be email [sic] to Educator...” Review of the “Nursing Monthly Checklist” revealed, “To be done by the NM monthly - turn in with QA monthly ... 1. During Infection Control Audit, observe for...” Interview on 01/10/2024 at 1730 with the AOD revealed monthly Infection Control audits were not available for review. Interview revealed, “I have asked for them and they have not been done.” Interview on 01/12/2024 at 1744 with the NM revealed that she was hired in the role as NM in 2021. Interview revealed, “I did not know that I was supposed to do monthly Infection Control audits, but I do now.” The interview revealed the educator completes an IC audit annually and sends the information to the NM. The NM shared that she thought the annual IC audit was all that was required. Interview revealed, “I didn’t have anyone providing oversight. [Preceptor] left a couple of months after my promotion to NM and I thought I was doing fine.” Interview on 01/12/2024 at 1845 with the Nurse Educator revealed the she was responsible for conducting an annual Infection Control audit at the facility and that the NM is responsible for conducting monthly Infection Control audits. The interview revealed NMs are given a new nurse manager orientation guide during orientation and are responsible for ensuring the checklist is completed with the preceptor. Telephone interview with the Medical Director and AOD on 01/22/2024 at 1645, the Medical Director shared, “Most of the time, [AOD] and I are not there, and we depend on the NM to let us know when things need our attention.” Interview revealed the Medical Director was not aware that monthly Infection Control audits had not been completed until being updated of the survey findings by the AOD. Interview revealed, “Perhaps some of the survey findings may have been mitigated had there been ongoing monitoring of [IC] practices.” During the interview, the AOD shared that the NM was sent to training and that NM duties and responsibilities were covered on the “Nurse Manager checklist” [New Nurse Manager Orientation Guide], which was not in the NM’s personnel file when reviewed on 01/12/2024.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 35306 Based on facility policy review, observations, and staff interview, the facility staff failed to follow infection control standard precautions by failing to disinfect CVC hubs “vigorously” and “thoroughly with friction” and to ensure a new alcohol pad was used on each hub in 1 of 2 CVC initiations (Patient #5, NM). Findings included: Review on 01/12/2024 of the facility policy titled, “Central Venous Catheter (CVC) Scrub the Hub Protocol for Connection and Disconnection, DATE ADOPTED: 1/18/2023” revealed, “... The use of catheters for hemodialysis is the most common factor contributing to bacteremia [bacteria in the blood] in patients on dialysis ... Careful attention to hub care can decrease the CRBSI [catheter related blood stream infection] rate almost 4-fold to a rate approaching 1 episode/1000 days. Due to the increasing microbial resistance to mainstream antibiotics, infection prevention must be considered the first rule of vascular access maintenance. Increased awareness at the individual center level is key to stemming access infection and its extreme consequences, such as endocarditis, and metastatic infections ...The success and longevity of a vascular access is in part dependent on the knowledge and skilled staff, coupled with routine surveillance and maintenance of the access ... PROCEDURE ... 4. remove the cap from venous port and disinfect the hub vigorously with an approved disinfectant pad: Scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue (e.g., blood) from hubs. Repeat the same step for the arterial port. Ensure a new swab is used on each hub ...” Observation on 01/12/2024 at 1010 revealed that the NM accessed Patient #5’s CVC for initiation of hemodialysis. Observation revealed the NM removed the hub cap for the arterial line, swiped the hub with an alcohol swab for 2-3 seconds and attached a syringe. Observation revealed the same process was followed for the venous line. Observation revealed the NM removed the syringe to the arterial line, swiped the hub with an alcohol swab for 2-3 seconds, connected the arterial line, and used the same alcohol swab to swipe the second hub and connected the venous line. Observation revealed the NM failed to disinfect the arterial and venous hubs “vigorously” and “thoroughly with friction” and failed to ensure “a new swab was used on each hub” per the facility’s “Universal Precautions” policy. Interview on 01/12/2024 at 1744 with the NM revealed that there was no set time for scrubbing the hubs of the CVCs. Interview revealed, “I was so nervous, and I know I messed up.” Interview revealed swiping the hubs was not acceptable practice and that a new alcohol swab should have been used. Interview on 01/12/2024 at 1855 with the AOD revealed hubs should be scrubbed vigorously and thoroughly and that a new alcohol swab should be used on each hub.”

“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: 35306 Based on observation and staff interview, the facility staff failed to ensure that acid concentrates stored in 55-gallon drum containers were kept tightly closed to prevent potential contamination during non-use in 1 of 1 observed acid concentrate 55-gallon drums in the acid storage area. Findings included: Review on 01/12/2024 revealed there was no policy addressing the safety and expected condition of the acid storage area. Observation on 01/11/2024 at 1355 in the facility’s supply storage area revealed a plastic acid transfer pump stored inside the top port opening of a 55-gallon blue drum of 1K (potassium) 2.5 Ca+ (calcium) acid concentrate that was not tightly closed/sealed down when not in use. The top port cap/lid for the 55-gallon drum was observed lying on top of the drum. Observation revealed the 55-gallon drum of acid concentrate was left open for potential contamination. Further observation revealed that prior to touring the area with the facility’s Biomedical staff, no staff members were in the supply area at the time of the observation. Interview on 01/11/2024 at 1355 with the ATM and facility CT revealed that staff must have forgotten to remove the acid transfer pump and to replace the cap at the end of the day (01/10/2024). Interview revealed the drum cap should have been replaced. The interview confirmed the findings. Interview with the AOD on 01/11/2024 at 1715 revealed the drum cap should have been replaced, “at least by the end of the day” on 01/10/2024.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 35306 Based on facility policy review, “Platinum Series XL, 5, 10 Oxygen Concentrators” operator’s manual review, observation, review of equipment logs and staff interview, the facility failed to ensure the routine maintenance was maintained on 2 of 2 oxygen concentrators per manufacturer recommendations. The findings are: Review on 01/12/2024 of the facility’s policy titled, “Maintenance of Equipment” (Date Issued: 04/03/2023) revealed, “4. Dialysis related ancillary equipment will be maintained following manufacture’s [sic] recommendation. Examples of this equipment include ... oxygen concentrators.” Review on 01/12/2024 of the “Platinum Series XL, 5, 10 Oxygen Concentrators” operator’s manual revealed, “... Routine Maintenance ... Cleaning the Cabinet Filter ... NOTE: There are two (2) cabinet filters one (1) located on each side of the cabinet. 1. Remove each filter and clean at least once a week depending on environmental conditions ... 2. Clean the cabinet filters with a vacuum cleaner or wash in warm soapy water and rinse thoroughly. 3. Dry the filters thoroughly before reinstallation... Cabinet ... 1. Clean the cabinet with a mild household cleaner and non-abrasive cloth or sponge. Humidifier ... 1. Clean the humidifier every day...” Review of the facility’s policy titled, “Routine Disinfection in the Hemodialysis Unit” (Date Issued: 01/16/2029) revealed, “ ...2. Any manufacturer’s guidance for sterilization or disinfection of an item should be followed ... 4. Oxygen concentrators will be wiped from top to bottom ... prior to removal from patient station. Filters will be removed and rinsed with manufacturer recommended disinfectants and allowed to dry before replacing.” Observation in the treatment area of the facility on 01/12/2024 at 1030 revealed two (2), Invacare Platinum Series oxygen concentrators in the facility’s designated laboratory area. Review of the “CLEANING LOG FOR CONCENTRATOR” on 01/12/2024 revealed one (1) cleaning log for “Concentrator #1” dated “March 2023” with a column titled, “After 1st shift” and a column titled, “After 2nd Shift” and check marks with staff initials from 03/01/2023 - 03/22/2023. Review of the log revealed no indication that “Concentrator #1” had been cleaned since 03/22/2023. Further review revealed the March 2023 cleaning log for Concentrator #1 was the only log available for review. Interview during the observation on 01/12/2024 at 1030 with the NM revealed, “Those [two (2) Platinum Series oxygen concentrators] are broken. I don’t know why they’re there [designated laboratory area].” CCHT #1 overheard the NM’s comments and stated, “Those aren’t broken, we used one of them on a patient last week.” The NM stated, “I don’t know, we will have to check with [biomed staff].” Interview revealed the NM was not aware that the cleaning logs were not up-to-date or what the routine maintenance requirements were for the oxygen concentrators. Interview on 01/12/2024 at 1045 with CCHT #1 revealed that the oxygen concentrator filters were “cleaned every day with warm soapy water and let them air dry. I don’t know why the log hasn’t been kept up. You will have to ask [NM] about that.” Interview revealed CCHT #1 was not aware of the routine maintenance requirements for the oxygen concentrators. Interview with the biomedical staff on 01/12/2024 at 1125 revealed preventive maintenance was performed by an outside contracted agency on 11/09/2023 for the two (2) Invacare Platinum Series oxygen concentrators with no issues or concerns identified. Given the confusion surrounding the current functionality of the two (2) oxygen concentrators, both were removed from the designated lab area. Interview with the biomedical staff on 01/12/2024 at 1615 revealed the ATM contacted the outside contracted agency and had a technician come to the facility to test the functionality of the two (2) oxygen concentrators. The ATM shared that both pieces of equipment were fully functional and passed all testing components. Interview on 01/12/2024 at 1855 with the AOD revealed, “I have no idea about those cleaning logs or why they haven’t been kept up. We’ve got a lot of work to do.””

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 35306 Based on policies and procedures, medical record review, and staff interview, the facility’s staff failed to document assessment and action taken in 1 of 4 sampled patients with elevated blood pressure readings during hemodialysis treatments (Patient #1). Findings included: Review on 01/12/2024 of the facility’s policy titled “Management of Hypertension during Hemodialysis - (DATE ISSUED: 02/23/2023)” revealed “... Hypertension should be treated to reduce the risk of stroke and cardiac events ... POLICY: 1. A licensed nurse must assess the patient for hypertension. 2. Notify physician for further orders if symptomatic hypertension is noted during dialysis or if blood pressure is out of established parameters. 3. Clinics will establish parameters of when to report hypertension to the physician (i.e., Systolic BP >180 mmHg & Diastolic BP >100 mmHg) ... 12. All interventions will be documented on the flowsheet to provide complete record of care.” Medical record review on 01/11/2024 for Patient #1 revealed the patient was admitted to the facility on 08/16/2023 for ICHD treatment. Review of the patient’s treatment flowsheet dated 01/03/2024 revealed that hemodialysis treatment was provided for the patient from 1121 - 1500 for a total of 3 hours and 39 minutes. The documentation by PCT #2 at 1131 revealed the patient’s blood pressure was elevated at “187/100” with a note by PCT #2 stating, “TX Complication: HYPERTENSION.” Review revealed the patient’s blood pressure was not retaken until 1201 (30 minutes later) by PCT #2. Review of the treatment flowsheet revealed at 1301, the patient’s blood pressure was elevated at “181/100” by PCT #1 and was not retaken until 1331 (30 minutes later) and noted as “174/103” by PCT #1. Review revealed the blood pressure was not retaken until 1401 (30 minutes later) by PCT #1. Review of the treatment flowsheet “Procedures, Complications & Notes” revealed notation at 1134 by PCT #2 stating, “11:31 AM HYPERTENSION note: diastolic.” The documentation failed to reveal documented evidence of notification to the facility’s nursing staff or physician, a nursing assessment of the patient’s blood pressure, and nursing interventions prior to the end of treatment. Review of the patient’s treatment flowsheet dated 01/05/2024 revealed that hemodialysis treatment was provided for the patient from 1107 - 1441 for a total of 3 hours and 34 minutes. The documentation by PCT #1 at 1231 revealed the patient’s blood pressure was elevated at “192/104” and not retaken until 1301 (30 minutes later) by PCT #2 and was elevated at “209/105”. At 1301, PCT #2 charted, “TX Complication: HYPERTENSION.” The patient’s blood pressure was rechecked at 1305 (4 minutes later) by PCT #2 and noted as “193/91” on the treatment flowsheet. Review revealed at 1401, the patient’s blood pressure was elevated at “201/100” by PCT #1 and not retaken again until 1431 (29 minutes later) by PCT #2. Review of the treatment flowsheet “Procedures, Complications & Notes” revealed notation by PCT #2 stating, “01:01 PM HYPERTENSION note: adj [adjust] and recheck (1:04 PM).” The documentation failed to reveal documented evidence of notification to the facility’s nursing staff or physician, a nursing assessment of the patient’s blood pressure, and nursing interventions prior to the end of treatment. Review of the patient’s treatment flowsheet dated 01/10/2024 revealed the hemodialysis was provided for the patient from 1105 - 1510 for a total of 3 hours and 55 minutes. The documentation by PCT #2 at 1230 revealed the patient’s blood pressure was noted as “189/102” and not retaken until 1301 (31 minutes later). Review revealed at 1301, “TX Complication: HYPERTENSION” was noted by PCT #2. Interview on 01/11/2024 at 1730 with the facility’s AOD revealed that the PCTs should have documented notification of the facility’s nursing staff of the elevated blood pressures and that there should have been a documented assessment of the patient by the nursing staff. The interview revealed that facility staff are educated to report elevated blood pressures. The interview confirmed the medical record finding. Interview on 01/12/2024 at 1744 with the facility’s NM revealed PCTs should report outliers on patient assessment to the nurse for follow-up. During review of the treatment flowsheet for Patient #1 dated 01/03/2024, the NM confirmed findings.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 35306 Based on policy review, “Annual Standing Hemodialysis Outpatient Orders” review, medical record review, and staff interview, the facility staff failed to ensure ICHD patients were receiving dialysis per physicians orders and to document changes on the treatment flowsheet in 2 of 4 patients sampled (Patients’ #1 and #2). Findings included: Review of the facility policy titled, “RANGES FOR ADEQUATE BLOOD FLOW” (Effective: 02/12/2012) revealed, “... If blood flow rates are changed during treatment but are in the acceptable guidelines, they must be explained.” Review of the facility’s “Annual Standing Hemodialysis Outpatient Orders” revealed, “6. Blood Flow Rate: May increase or decrease as tolerated by vascular access. Any changes need to be reported to the CN/TL [Charge Nurse/Team Lead] and documented on flow sheet.” 1. Medical record review on 01/11/2024 for Patient #1 revealed a 46-year-old male was admitted to the facility for ICHD on 08/16/2023. Review of the physician order dated 11/20/2023 revealed the patient’s prescribed BFR was 350. Review of the patient’s treatment flowsheet for 01/10/2024, revealed the patient received hemodialysis from 1103 to 1510 (4 hours and 7 minutes) with a BFR of 400 (50 more than the prescribed rate). Review revealed no documentation as to why the BFR was increased. Interview on 01/12/2024 at 1744 with the NM revealed, “I need to talk to staff. They are use to the previous prescription and are not checking it in the new EHR [electronic health record]. I expect a note explaining why [staff are unable to achieve the prescribed BFR].” The interview confirmed the finding. 2. Medical record review on 01/11/2024 for Patient #2 revealed a 73-year-old male was admitted to the faciltiy of ICHD on 05/12/2022. Review of the physician order dated 12/05/2023 revealed the patient’s prescribed BFR was 400. Review of the patient’s treatment flowsheet for 12/13/2023, revealed the patient received hemodialysis from 1155 to 1558 (4 hours and 3 minutes) with a BFR of 450 (50 more than the prescribed rate). Review revealed no documentation as to why the BFR was increased. Interview on 01/12/2024 at 1744 with the NM revealed, “I need to talk to staff. They are use to the previous prescription and are not checking it in the new EHR [electronic health record]. I expect a note explaining why [staff are unable to achieve the prescribed BFR].” The interview confirmed the finding.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 35306 Based on policy review, facilty “Care Plan Essentials Guide” review, “Nursing Monthly Checklist” review, medical record review, and staff interviews, the facility staff failed to ensure the patient’s plan of care was signed by the physician for 1 of 4 patient records sampled (Patient #7). Findings included: Review of the facility’s policy titled, “Care Plan” (no date) failed to reveal inclusion of verbiage for the requirement of interdisciplinary team members signatures on the Patient Plan of Care. Review on 01/12/2024 of the facility’s “Care Plan Essentials Guide” revealed, “ACP [Advanced Care Planning] DOCUMENTATION... SIGN & COMPLETE ... 6. After you click the Begin Signing button, each of the interdisciplinary team members should enter their digital signatures for them ... If there are unsigned care plans, you will receive a message upon logging in notifying you of which care plans you need to sign. 7. After all relevant information has been documented and all interdisciplinary team members enter their digital signatures, click the Mark Meeting as Complete button. This action also date stamps the care plan.” Review of the facility’s “Nursing Monthly Checklist” revealed, “To be done by NM monthly - turn in with QA [Quality Assurance] monthly...16. Make sure Rounding Nephrologist signs and dates careplans during rounds in all physician signature areas and in computer.” Medical record review on 01/10/2024 for Patient #7 revealed a 58-year-old female was admitted to the facility for ICHD on 03/18/2017. Review of the patient’s 2023 annual plan of care revealed a care plan meeting was held 06/12/2023. Review of the “Care Plan Meeting Attendance” revealed that plan of care did not include the physician’s electronic signature. Interview on 01/12/2024 at 1855 with the AOD revealed the patient plan of care should be signed by all team members, the day the care plan meeting occurs. Interview revealed team members receive alerts via the electronic health record, letting them know the plan has to be signed. Interview revealed, “I don’t know why he [physician] he hasn’t signed this one.” Interview confirmed findings.”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 35306 Based on staff interview, facility “Quality Assessment and Performance Improvement (QAPI)” Program review, “Monthly Nurse Manager Responsibilities” review, “Nursing Monthly Checklist” review, and QAPI Committee meeting minutes review, the facility leadership failed to maintain and demonstrate evidence of its QAPI program by failing to ensure QAPI Committee minutes were completed and available for review. Findings included: Interview on 01/10/2024 at 1730 with the AOD revealed that the QAPI Committee meeting minutes for the 10/20/2023 and 11/17/2023 QAPI Committee meetings were available for review; however, she was unable to produce QAPI Committee meeting minutes for 01/2023 - 09/2023 or 12/15/2023 meetings (10 months). Interview confirmed findings. Interview on 01/12/2024 at 1744 with the NM revealed that she had the QAPI Committee meeting minutes for 12/15/2023 completed and available for review. Interview confirmed the 12/15/2023 QAPI Committee meeting minutes were not completed and available for review when requested on 01/10/2024 and 01/11/2024. Review of the facility “Quality Assessment and Performance Improvement (QAPI)” Program revealed, “... The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement (QAPI) program for review by CMS [Centers for Medicare and Medicaid Services] ... Discussion on ... should be conducted during the QAPI meeting and documented in the QAPI meeting minutes. Provides documentation of indicator review ... QAPI meeting minutes provide evidence of discussions occurring during the QAPI meeting. Minutes should be comprehensive to include action steps, status updates, and required follow-up/plans ...” Review of the “Monthly Nurse Manager Responsibilities” revealed scheduled duties with the months due marked on the calendar with an “x” duties that were scheduled to be performed. Review monthly assigned duties included, “14. ... QA minutes ...” Review on 01/18/2024, of the QAPI Committee meeting minutes for 12/15/2023, received 01/12/2024 at approximately 1945, revealed documentation by the NM stating, “12.... a. Spoke to everyone about problems with QAPI and not being in compliant [sic] with documentation. Also shared meeting with [corporate nurse]. b. Plan of action to begin to keep QAPI in public, send copy to [AOD] and [corporate nurse] c. Will begin to check with corporate nurse and [AOD] to keep QAPI in compliance...””

“QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This Standard is not met as evidenced by: 35306 Based on review of the facility’s “Quality Assessment and Performance Improvement (QAPI)” Program review, “Clinical QAPI Workflow” algorithm review, “QAPI Report” review, “Iron” Action Plan review, QAPI Committee meeting minutes review, and staff interviews, the facility’s Interdisciplinary Team (IDT) failed to demonstrate evidence of ongoing development, implementation, and monitoring of action plans for Anemia, specifically, for the percentage of patients with Transferrin Saturation (TSAT) 30-50. Findings included: Review of the facility’s “Quality Assessment and Performance Improvement Program (QAPI),” (no date) revealed, “... The (QAPI) program must reflect the complexity of the dialysis facility’s organization and services ... The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement (QAPI) program for review by CMS [Centers for Medicare and Medicaid Services] ... The facility is required to continuously monitor its performance and take actions that result in performance improvements over time... 3. The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations... The program must include, but not be limited to the following ...Anemia Management ... If facility QAPI goals for anemia management are not achieved over consecutive evaluation periods, the facility IDT [interdisciplinary] team should conduct a review of transferrin saturation (TSAT) levels ... Discussion on Anemia Management....should be conducted during the QAPI meeting and documented in the QAPI meeting minutes ... 4. ... the IDT must: Review aggregate patient data; Identify any commonalities among patients who do not reach minimum expected targets; Develop a plan to address those causes; Implement the plan; Monitor the effectiveness of the plan; and Adjust portions of the plan that are not successful. Tracking and trending, analysis of root causes, development of improvement plans, implementation of those plans, evaluation of the success of the plan, and revision of the plan must occur as indicated ... Minutes should be comprehensive to include action steps, status updates, and required follow-up/plans ...” Review of the “Clinical QAPI Workflow” algorithm revealed, “... 4. Problems / Actions Enter any Problems or Action Steps that are relevant to the current section ... Problems/Action Steps are clinic and report specific. Any open problems will be carried over to the next month. You should mark each problem as Resolved once the Action Steps are completed. Review of the focus area “Anemia” on 01/11/2024 revealed the facility monitored outcomes at least monthly. Review revealed the facility was not meeting goal for the percentage of patients with Transferrin Saturation (TSATS) 30-50. Review of the facility’s goal was >=40%. Review of 2023 data revealed the following percentages for patients with TSATS 30-50: Feb: 13.6% March: 16.7% April: 20% May: 28% Jun: 34.8% July: 36.4% Aug: 36.4% Sep: 28.6% Oct: 30% Dec: 30.4% Review on 01/10/2024 of the QAPI Action Plan titled, “Iron” revealed Problem No.1 was identified as “Low T Sats” on 09/09/2020. Review of the “Action Steps” revealed the “Status” of the plan had not been updated since “04/12/2022”. Review on 01/11/2024 of the QAPI Committee meeting minutes revealed there were no QAPI meeting minutes for review for 01/2023 - 09/2023 or 12/2023 (10 months). Review on 01/11/2024 of the QAPI Committee meeting minutes for 10/20/2023 revealed the facility’s percentage of patients with TSATs 30-50 was not met at 28.5% [sic] in September, with “Root cause [a factor that caused a nonconformance and should be permanently eliminated through process improvement]: 15 patients not met T sats [normal reference range: 15-50] due to inflammation process in several, missed treatments. Plan - Review Iron Protocol and adjust orders as per orders. Run anemia report and review outliers and protocols. Speak to patients about coming to treatments and not cutting time” noted in the minutes. Review of the QAPI meeting minutes for 11/17/2023 revealed the facility’s percentage of patients with TSATs 30-50 was not met at 30% in October, with “Root cause: 14 patients not met T sats due to inflammation process in several (1 patient), some with excessive missed treatments and early termination (4 patients). Plan - continue to: Review Iron Protocol and adjust orders as per orders. Run anemia report and review outliers and protocols. Speak to patients about coming to treatments and not cutting time” noted in the minutes. Review on 01/18/2024, of the 12/15/2023 QAPI meeting minutes, received 01/12/2024 at approximately 1945, revealed the facility’s percentage of patients with TSATs 30-50 was met at 47.6% in November. Further review of the meeting minutes revealed, “12.... a. Spoke to everyone about problems with QAPI and not being in compliant [sic] with documentation. Also shared meeting with [corporate nurse]. b. Plan of action to begin to keep QAPI in public, send copy to [AOD] and [corporate nurse] c. Will begin to check with corporate nurse and [AOD] to keep QAPI in compliance...” Interview on 01/11/2024 at 1730 with the facility’s AOD revealed there were no QAPI Committee meeting minutes for 01/2023 - 09/2023 or 12/2023 (10 months) available for review. “I have requested them, and they have not been done. We have discussed these during our monthly QAPI meetings and action plans should have been updated monthly as indicated.” Interview confirmed findings. Interview with the facility’s NM on 01/12/2024 at 1744 revealed she was hired in the role as NM in 2021 but did not fully understand the QAPI program or how to update Action Plans until working with the corporate nurse “sometime in July or August” of 2023. Interview revealed, “When I got this position, I was trained by someone with many hats, who was also training other staff in various positions, who got pulled away a lot. QAPI was a huge thing I didn’t understand. I sat in a couple of meetings [with the preceptor] and just didn’t get it.” Interview revealed, “I failed to reach out for help, I was overwhelmed and didn’t get an understanding of it [QAPI]. Then I went to a new NM training in November and got a better understanding of it.” Interview revealed, “I sat in those meeting every month but just did not understand my responsibilities.” Interview revealed, “I didn’t have anyone providing oversight. [Preceptor] left a couple of months after my promotion to NM and I thought I was doing fine. I got reports from QAPI and just reported out what I got.” The NM shared that she now has a better understanding and has developed a plan for keeping QAPI in compliance. Telephone interview with the Medical Director and AOD on 01/22/2024 at 1645, the Medical Director shared, “Most of the time, [AOD] and I are not there, and we depend on the NM to let us know when things need our attention.” Interview revealed the Medical Director was aware the NM had “a lot going on but was surprised when [AOD] told me about the survey, especially the lack of QAPI Committee and Governing Body meeting minutes. I’ve been in this area [dialysis] 30 years and have never had anything like this happen. This is also my fault, but we do depend heavily on the NM. I am very embarrassed and want you to know that this is not at all a reflection of the care that we provide for our patients.” The interview revealed the Medical Director was not aware that QAPI Committee meeting minutes and Governing Body meeting minutes were missing or that Action Plans had not been updated per facility policies. Interview revealed the facility’s previous practice had been to review quality metrics without the printed QAPI Report with aggregated data and Action Plans but that going forward, the QAPI report would be printed for review by the interdisciplinary team during monthly QAPI Committee meetings and Governing Body meetings. “My expectation is that company policies and procedures are followed.””

“QAPI-INDICATOR-VASCULAR ACCESS CFR(s): 494.110(a)(2)(v) The program must include, but not be limited to, the following: (v) Vascular access. This Standard is not met as evidenced by: 35306 Based on review of the facility’s” Quality Assessment and Performance Improvement (QAPI)” Program review, “Clinical QAPI Workflow” algorithm review, “QAPI Report” review, Action Plan review, QAPI meeting minutes review, and staff interviews, the facility’s Interdisciplinary Team (IDT) failed to demonstrate evidence of ongoing development, implementation, and monitoring of action plans as it related to the high catheter percentage rate for its patient census of hemodialysis patients. Findings included: Review of the facility’s policy “Quality Assessment and Performance Improvement Program (QAPI),” no date provided, revealed “... The (QAPI) program must reflect the complexity of the dialysis facility’s organization and services ... The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement (QAPI) program for review by CMS [Centers for Medicare and Medicaid Services] ... The facility is required to continuously monitor its performance and take actions that result in performance improvements over time... 3. The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations... The program must include, but not be limited to the following ...Vascular Access... Discussion on Vascular Access ... should be conducted during the QAPI meeting and documented in the QAPI meeting minutes ... To identify opportunities for improvement and track progress for all QAPI indicators, the IDT must ... Develop a plan to address those causes; Implement the plan; Monitor the effectiveness of the plan; and Adjust portions of the plan that are not successful. Tracking and trending, analysis of root causes, development of improvement plans, implementation of those plans, evaluation of the success of the plan, and revision of the plan must occur as indicated. Once improvement is made, the facility must have a mechanism to ensure that improvement is sustained ...” Review of the “Clinical QAPI Workflow” algorithm revealed, “... 4. Problems / Actions Enter any Problems or Action Steps that are relevant to the current section ... Problems/Action Steps are clinic and report specific. Any open problems will be carried over to the next month. You should mark each problem as Resolved once the Action Steps are completed. Review of the focus area “Vascular Access “ on 01/11/2024 revealed the facility monitored outcomes at least monthly. Review revealed the facility was not meeting goal for Vascular Access. Review of the facility’s goals for catheter rate >90 days percentage revealed that 10% was the maximum rate for its patient population to have catheters as vascular access sites >90 days. Review of 2023 data revealed the following percentages for patients with catheters >90days: Jan: 30% Feb: 21.7% March: 25.0% April: 16% May: 17.4% Jun: 18.2% July: 19% Aug: 14.3% Sep: 15% Nov: 13.6% Dec: 25% Review on 01/10/2024 of the QAPI Action Plan titled, “Vascular Access” revealed Problem No. 1 was identified as “PATIENTS DO NOT GET PERMANENT ACCESS PLACED PRIOR TO STARTING DIALYSIS” on 03/07/2022. Review of the “Action Steps” revealed the “Status” of the plan had not been updated since “05/26/2022”. Review on 01/11/2023 of the QAPI Committee meeting minutes revealed there were no QAPI meeting minutes for review for 01/2023 - 09/2023 or 12/2023 (10 months). Review on 01/11/2024 of the QAPI Committee meeting minutes for 10/20/2023 revealed the facility’s catheter rate was 15% of the patients having catheters as their vascular access >90 days in September with, “Plan: continue to speak with patients about fears” noted in the minutes. Review of the QAPI Committee meeting minutes for 11/17/2023 revealed the facility’s catheter rate >90 days was unchanged at 15% in October, with “Plan: Continue to encourage patient to start cannulation, patient does not understand the risk of infection with catheter” noted in the minutes. Review on 01/18/2024 of the 12/15/2023 QAPI meeting minutes, received 01/12/2024 at approximately 1945, revealed the percentage of patients with catheters >90 days increased to 18.2% (3.2% increase) in November, with “Plan: Remind patients with maturing access of follow up appointments.” Further review of the meeting minutes revealed, “12.... a. Spoke to everyone about problems with QAPI and not being in compliant [sic] with documentation. Also shared meeting with [corporate nurse]. b. Plan of action to begin to keep QAPI in public, send copy to [AOD] and [corporate nurse] c. Will begin to check with corporate nurse and [AOD] to keep QAPI in compliance...” Interview on 01/11/2024 at 1730 with the facility’s AOD revealed there were no QAPI Committee meeting minutes for 01/2023 - 09/2023 or 12/2023 (10 months) available for review. “I have requested them, and they have not been done. We have discussed these during our monthly QAPI meetings and action plans should have been updated monthly as indicated.” Interview with the facility’s NM on 01/12/2024 at 1744 revealed she was hired in the role as NM in 2021 but did not fully understand the QAPI program or how to update Action Plans until working with the corporate nurse “sometime in July or August” of 2023. Interview revealed, “When I got this position, I was trained by someone with many hats, who was also training other staff in various positions, who got pulled away a lot. QAPI was a huge thing I didn’t understand. I sat in a couple of meetings [with the preceptor] and just didn’t get it.” Interview revealed, “I failed to reach out for help, I was overwhelmed and didn’t get an understanding of it [QAPI]. Then I went to a new NM training in November and got a better understanding of it.” Interview revealed, “I sat in those meeting every month but just did not understand my responsibilities.” Interview revealed, “I didn’t have anyone providing oversight. [Preceptor] left a couple of months after my promotion to NM and I thought I was doing fine. I got reports from QAPI and just reported out what I got.” The NM shared that she now has a better understanding and has developed a plan for keeping QAPI in compliance. Telephone interview with the Medical Director and AOD on 01/22/2024 at 1645, the Medical Director shared, “Most of the time, [AOD] and I are not there, and we depend on the NM to let us know when things need our attention.” Interview revealed the Medical Director was aware the NM had “a lot going on but was surprised when [AOD] told me about the survey, especially the lack of QAPI Committee and Governing Body meeting minutes. I’ve been in this area [dialysis] 30 years and have never had anything like this happen. This is also my fault, but we do depend heavily on the NM. I am very embarrassed and want you to know that this is not at all a reflection of the care that we provide for our patients.” The interview revealed the Medical Director was not aware that QAPI Committee meeting minutes and Governing Body meeting minutes were missing or that Action Plans had not been updated per facility policies. Interview revealed the facility’s previous practice had been to review quality metrics without the printed QAPI Report with aggregated data and Action Plans but that going forward, the QAPI report would be printed for review by the interdisciplinary team during monthly QAPI Committee meetings and Governing Body meetings. “My expectation is that company policies and procedures are followed.””

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 35306 Based on review of the facility’s” Quality Assessment and Performance Improvement (QAPI)” Program review, “Clinical QAPI Workflow” algorithm review, quality assurance reports review, facility Occurrence report review, QAPI meeting minutes review, and staff interviews, the facility’s Interdisciplinary Team (IDT) failed to demonstrate evidence of analysis, tracking, and monitoring of patient occurrences. Findings included: Review of the facility’s policy “Quality Assessment and Performance Improvement Program (QAPI),” no date provided, revealed “... The (QAPI) program must reflect the complexity of the dialysis facility’s organization and services ... The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement (QAPI) program for review by CMS [Centers for Medicare and Medicaid Services] ... The facility is required to continuously monitor its performance and take actions that result in performance improvements over time... 3. The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations... The program must include, but not be limited to the following ... Medical injuries and medical errors identification ... The facility must compile and the QAPI team must review reports and complaints related to any patient or staff injuries, and treatment or medication errors. The facility must trend any injuries or errors to identify the prevalence of occurrences, commonalities, and causes. The following list represents the minimum elements required....to be reported/tracked ... e) errors in dialysis prescription delivery f) Medication error, omissions, adverse reactions ... m) Patient falls ... ff) Near-Miss events ... Discussion on Medical injuries and medical errors identification.... should be conducted and [sic] during the QAPI meeting and documented in the QAPI meeting minutes ...” Review of the “Clinical QAPI Workflow” algorithm revealed, “... 4. Problems / Actions Enter any Problems or Action Steps that are relevant to the current section ... Problems/Action Steps are clinic and report specific. Any open problems will be carried over to the next month. You should mark each problem as Resolved once the Action Steps are completed. Review of the focus area “Occurrences” on 01/11/2024 revealed 17 indicators for tracking and monitoring, including number of events with Near miss without injury, number of events with Falls, and number of events with Medication error. Review of the facility “Occurrences” scorecard for 2023 revealed one (1) occurrence in May 2023 under the number of patients with transfer to the hospital from the clinic indicator. Review revealed zero (0) occurrences for all other indicators for 2023 scorecard. Review on 01/11/2024 of the facility “Occurrences” report revealed two (2) patient occurrences: One on 08/28/2023 for Patient #5 listed as a “Fall” in the “Bathroom” type of event and another event was entered into the facility’s electronic database on 09/25/2023 for Patient #1 listed as a “Hemodialysis” type of event. Review on 01/11/2024 of the QAPI Committee meeting minutes revealed there were no QAPI meeting minutes for review for 01/2023 - 09/2023 or 12/2023 (10 months). Review on 01/11/2024 of the QAPI Committee meeting minutes for 10/20/2023 revealed, “No occurrences this month.” Review of the QAPI Committee meeting minutes for 11/17/2023 revealed “Occurrences” was not addressed in the meeting minutes. Review on 01/18/2024 of the 12/15/2023 QAPI meeting minutes, received 01/12/2024 at approximately 1945, revealed “Occurrences” was not addressed in the meeting minutes. Further review of the meeting minutes revealed, “12.... a. Spoke to everyone about problems with QAPI and not being in compliant [sic] with documentation. Also shared meeting with [corporate nurse]. b. Plan of action to begin to keep QAPI in public, send copy to [AOD] and [corporate nurse] c. Will begin to check with corporate nurse and [AOD] to keep QAPI in compliance...” Interview on 01/11/2024 at 1730 with the facility’s AOD revealed there were no QAPI Committee meeting minutes for 01/2023 - 09/2023 or 12/2023 (10 months) available for review. “I have requested them, and they have not been done. We have discussed these during our monthly QAPI meetings and action plans should have been updated monthly as indicated.” Interview revealed the two occurrences from 08/28/2023 and 09/25/2023 should have been captured on the facility’s Occurrence scorecard and were not. Interview confirmed the findings. Interview with the facility’s NM on 01/12/2024 at 1744 revealed she was hired in the role as NM in 2021 but did not fully understand the QAPI program or how to update Action Plans until working with the corporate nurse “sometime in July or August” of 2023. Interview revealed, “When I got this position, I was trained by someone with many hats, who was also training other staff in various positions, who got pulled away a lot. QAPI was a huge thing I didn’t understand. I sat in a couple of meetings [with the preceptor] and just didn’t get it.” Interview revealed, “I failed to reach out for help, I was overwhelmed and didn’t get an understanding of it [QAPI]. Then I went to a new NM training in November and got a better understanding of it.” Interview revealed, “I sat in those meeting every month but just did not understand my responsibilities.” Interview revealed, “I didn’t have anyone providing oversight. [Preceptor] left a couple of months after my promotion to NM and I thought I was doing fine. I got reports from QAPI and just reported out what I got.” The NM shared that she now has a better understanding and has developed a plan for keeping QAPI in compliance. Telephone interview with the Medical Director and AOD on 01/22/2024 at 1645, the Medical Director shared, “Most of the time, [AOD] and I are not there, and we depend on the NM to let us know when things need our attention.” Interview revealed the Medical Director was aware the NM had “a lot going on but was surprised when [AOD] told me about the survey, especially the lack of QAPI Committee and Governing Body meeting minutes. I’ve been in this area [dialysis] 30 years and have never had anything like this happen. This is also my fault, but we do depend heavily on the NM. I am very embarrassed and want you to know that this is not at all a reflection of the care that we provide for our patients.” The interview revealed the Medical Director was not aware that QAPI Committee meeting minutes and Governing Body meeting minutes were missing, that Action Plans had not been updated per facility policies, or that patient occurrences were not being captured on the facility “QAPI Report”. Interview revealed the facility’s previous practice had been to review quality metrics without the printed QAPI Report with aggregated data and Action Plans but that going forward, the QAPI report would be printed for review by the interdisciplinary team during monthly QAPI Committee meetings and Governing Body meetings. “My expectation is that company policies and procedures are followed.””

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 35306 Based on review of the facility’s “Infection Control Audit” policy, “Quality Assessment and Performance Improvement (QAPI)” Program review, “Clinical QAPI Workflow” algorithm review, “QAPI Report” review, “Monthly Nurse Manager Responsibilities” review, “Nursing Monthly Checklist” review, QAPI meeting minutes review, and staff interviews, the facility’s Interdisciplinary Team (IDT) failed to demonstrate evidence of continuous monitoring of Infection Control practices within the facility. Findings included: Review on 01/12/2024 of the facility policy titled, “Infection Control Audit - Hospital Services” revised 10/2013 revealed, “... 1. At a minimum of once per quarter, the Nurse Manager or a designated [organization] staff member will audit the Hospital Services program for compliance with infection control guidelines. 2. The Infection Control Audit Tool (Attachment 608 A) will be used to complete the audit of the Hospital Services program. 3 The findings of the audit will be presented by the Nurse Manager at the monthly Quality Management. A plan of correction will be implemented for any areas of deficiency ... PROCEDURE ... 2. Document notes related to areas of non-compliance in the Corrective Action section of the Infection Control Audit Tool. 3. Present the information at the Monthly QAPI meeting and discuss the plan of correction.” Review of “Attachment 608 A - Infection Control Audit Tool” revealed a comprehensive checklist for assessment of compliance to include, “General Infection Control Processes ... Isolation ... Medication ... Staff Compliance ... Patient Compliance ... General Compliance ... Hepatitis Compliance ... Patient Specific Compliance ... Medication Compliance ... Employment Compliance.” Review of the facility’s policy “Quality Assessment and Performance Improvement Program (QAPI),” no date provided, revealed “... The (QAPI) program must reflect the complexity of the dialysis facility’s organization and services ... The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement (QAPI) program for review by CMS [Centers for Medicare and Medicaid Services] ... The facility is required to continuously monitor its performance and take actions that result in performance improvements over time... 3. The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations... The program must include, but not be limited to the following ...4. The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time... “Continuously monitor” requires that outcome data, achievement of treatment goals, adverse events, infections, falls, errors, etc. be monitored as this data is available or these events occur...” Review of the “Clinical QAPI Workflow” algorithm revealed, “... 4. Problems / Actions Enter any Problems or Action Steps that are relevant to the current section ... Problems/Action Steps are clinic and report specific. Any open problems will be carried over to the next month. You should mark each problem as Resolved once the Action Steps are completed. Review of the focus areas “Miscellaneous” on 01/11/2024 revealed the facility monitored Infection Control (IC) outcomes at least monthly. Review revealed the facility was not meeting goal for Infection Control Audits. Review of the facility’s goal for Infection Control Audits revealed that >=90% was the expected rate for compliance. Review of 2023 data revealed no data was available for review. Review failed to reveal documentation of an action plan addressing performance improvement measures to achieve measurable improvement of Infection Control Audits. Review on 01/11/2024 of the QAPI Committee meeting minutes revealed there were no QAPI meeting minutes for review for 01/2023 - 09/2023 or 12/2023 (10 months). Review of the “Monthly Nurse Manager Responsibilities” revealed scheduled duties with the months due marked on the calendar with an “x” duties that were scheduled to be performed. Review of the listed duties revealed, “... 11. Corporate Infection Control Audit every other month (make sure you are able to evaluate each staff member for correct procedures at least once per year - put in QA [Quality Assurance]” were due to be performed every other month beginning in January. Review of monthly assigned duties included, “14. Infection control audits, QA minutes and RM minutes ... 55. Follow up on Action Plans in QAPI to ensure that all areas are being addressed and completed in a timely manner.” Further review of the scheduled NM responsibilities revealed, “Items due... 5 days after QAPI meeting - QAPI and RM Minutes along with Infection Control audit, NM responsibilities, and Items to be reviewed form all to be email [sic] to Educator...” Review of the “Nursing Monthly Checklist” revealed, “To be done by the NM monthly - turn in with QA monthly ... 1. During Infection Control Audit, observe for...” Review on 01/11/2024 of the QAPI Committee meeting minutes for 10/20/2023, 11/17/2023, and 12/15/2023 revealed no documentation of discussion or review of Infection Control audit findings. Further review on 01/18/2024, of the QAPI Committee meeting minutes for 12/15/2023, received 01/12/2024 at approximately 1945, revealed documentation by the NM stating, “12.... a. Spoke to everyone about problems with QAPI and not being in compliant [sic] with documentation. Also shared meeting with [corporate nurse]. b. Plan of action to begin to keep QAPI in public, send copy to [AOD] and [corporate nurse] c. Will begin to check with corporate nurse and [AOD] to keep QAPI in compliance...” Review failed to reveal documentation of an action plan addressing Infection Control Audit measures to achieve measurable improvement of Infection Control practices within the facility.” Interview on 01/11/2024 at 1730 with the facility’s AOD revealed there were no QAPI Committee meeting minutes for 01/2023 - 09/2023 or 12/2023 (10 months) available for review. “I have requested them, [QAPI meeting minutes and Infection Control Audits] and they have not been done. We [organization] have a calendar for all NMs with monthly responsibilities listed out and the months the reports are due. We have discussed Infection Control during our monthly QAPI meetings, but I have not printed off the QAPI Report to actually see the areas I’m looking at now. Infection Control audits should have been done monthly and they were not.” Interview confirmed findings. Interview with the facility’s NM on 01/12/2024 at 1744 revealed that she was hired in the role as NM in 2021 but did not fully understand the QAPI program or how to update Action Plans until working with the corporate nurse “sometime in July or August” of 2023. Interview revealed, “When I got this position, I was trained by someone with many hats, who was also training other staff in various positions, who got pulled away a lot. QAPI was a huge thing I didn’t understand. I sat in a couple of meetings [with the preceptor] and just didn’t get it.” Interview revealed, “I failed to reach out for help, I was overwhelmed and didn’t get an understanding of it [QAPI]. Then I went to a new NM training in November and got a better understanding of it.” Interview revealed, “I sat in those meetings every month but just did not understand my responsibilities. I did not know that I was supposed to do monthly Infection Control audits, but I do now.” The interview revealed the educator completes an IC audit annually and sends the information to the NM. The NM shared that she thought the annual IC audit was all that was required. Interview revealed, “I didn’t have anyone providing oversight. [Preceptor] left a couple of months after my promotion to NM and I thought I was doing fine. I got reports from QAPI and just reported out what I got.” The NM shared that she now has a better understanding and has developed a plan for keeping QAPI in compliance. Telephone interview with the Medical Director and AOD on 01/22/2024 at 1645, the Medical Director shared, “Most of the time, [AOD] and I are not there, and we depend on the NM to let us know when things need our attention.” Interview revealed the Medical Director was aware the NM had “a lot going on but was surprised when [AOD] told me about the survey, especially the lack of QAPI Committee and Governing Body meeting minutes. I’ve been in this area [dialysis] 30 years and have never had anything like this happen. This is also my fault, but we do depend heavily on the NM. I am very embarrassed and want you to know that this is not at all a reflection of the care that we provide for our patients.” The interview revealed the Medical Director was not aware that QAPI Committee meeting minutes and Governing Body meeting minutes were missing, that Action Plans had not been updated per facility policies, or that monthly Infection Control audits had not been performed. Interview revealed, “Perhaps some of the survey findings may have been mitigated had there been ongoing monitoring of [IC] practices.” Interview revealed the facility’s previous practice had been to review quality metrics without the printed QAPI Report with aggregated data and Action Plans but that going forward, the QAPI report would be printed for review by the interdisciplinary team during monthly QAPI Committee meetings and Governing Body meetings. “My expectation is that company policies and procedures are followed.””

“MD RESP-QAPI PROGRAM CFR(s): 494.150(a) Medical director responsibilities include, but are not limited to, the following: (a) Quality assessment and performance improvement program. This Standard is not met as evidenced by: 35306 Based on Quality Assurance and Performance Improvement (QAPI) documentation review and staff interview, the Medical Director failed to ensure oversight of the QAPI program such that action plans were developed and updated for indicators not meeting established goals, ensuring “continuous” monitoring of Infection Control practices within the facility, inclusion of data and discussion of “Occurrences” during monthly QAPI Committee meetings, and ensuring completion of QAPI Committee and Governing Body meeting minutes as “evidence of discussions” per the facility’s QAPI Program. Findings included: Review of the facility’s policy “Quality Assessment and Performance Improvement Program (QAPI),” no date provided, revealed “... The (QAPI) program must reflect the complexity of the dialysis facility’s organization and services ... The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement (QAPI) program for review by CMS [Centers for Medicare and Medicaid Services] ... The facility is required to continuously monitor its performance and take actions that result in performance improvements over time... 3. The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations... The program must include, but not be limited to the following ...4. The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time... “Continuously monitor” requires that outcome data, achievement of treatment goals, adverse events, infections, falls, errors, etc. be monitored as this data is available or these events occur. To identify opportunities for improvement and track progress for all QAPI indicators, the IDT must: Review aggregate patient data; Identify any commonalities among patients who do not reach minimum expected targets; Develop a plan to address those causes; Implement the plan; Monitor the effectiveness of the plan; and Adjust portions of the plan that are not successful. Tracking and trending, analysis of root causes, development of improvement plans, implementation of those plans, evaluation of the success of the plan, and revision of the plan must occur as indicated. Once improvement is made, the facility must have a mechanism to ensure that improvement is sustained... QAPI meeting minutes provide evidence of discussions occurring during the QAPI meeting. Minutes should be comprehensive to include action steps, status updates, and required follow-up/plans ... 7. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS...” Review of the 2023 QAPI documentation failed to reveal program oversight. Initial review on 01/11/2024, of the QAPI documentation revealed missing QAPI Committee meeting minutes from 01/2023 - 09/2023 and 12/2023 (10 months), missing Governing Body meeting minutes from 01/2023 -12/2023 (12 months). Review on 01/18/2024 of the 12/15/2023 QAPI Committee meeting minutes, received 01/12/2024 at approximately 1945, revealed Governing Body meeting minutes; however, they were not readily available for review upon initial inquiry on 01/10/2024 or 01/11/2024. Review of the 10/20/2023 meeting minutes revealed the facility’s SW was “Present” for the committee meeting; however, review revealed no data or discussion from the addressing Quality of Life Results, Patient Satisfaction, Grievances, or Transplantation and “No minutes this month no issues or new agendas addressed” noted by the NM. Review of the 11/17/2023 QAPI Committee meeting minutes revealed no data or discussion regarding “Occurrences” or nursing measures from the NM. Review of the 10/20/2023, 11/17/2023, and 12/15/2023 QAPI Committee meeting minutes revealed action plans that had not been updated since 2022. Interview on 01/11/2024 at 1730 with the facility’s AOD revealed there were no QAPI Committee meeting minutes for 01/2023 - 09/2023 or 12/2023 (10 months) available for review. “I have requested them [QAPI meeting minutes and Infection Control Audits] and they have not been done. We [organization] have a calendar for all NMs with monthly responsibilities listed out and the months the reports are due. We have discussed Infection Control during our monthly QAPI meetings, but I have not printed off the QAPI Report to actually see these areas I’m looking at now. Infection Control audits should have been done monthly and they were not.” Interview confirmed findings. Interview with the facility’s NM on 01/12/2024 at 1744 revealed that she was hired in the role as NM in 2021 but did not fully understand the QAPI program or how to update Action Plans until working with the corporate nurse “sometime in June or July” of 2022. Interview revealed, “When I got this position, I was trained by someone with many hats, who was also training other staff in various positions, who got pulled away a lot. QAPI was a huge thing I didn’t understand. I sat in a couple of meetings [with the preceptor] and just didn’t get it.” Interview revealed, “I failed to reach out for help, I was overwhelmed and didn’t get an understanding of it [QAPI]. Then I went to a new NM training in November and got a better understanding of it.” Interview revealed, “I sat in those meeting every month but just did not understand my responsibilities. I did not know that I was supposed to do monthly Infection Control audits, but I do now.” The interview revealed the educator completes an IC audit annually and sends the information to the NM. The NM shared that she thought the annual IC audit was all that was required. Interview revealed, “I didn’t have anyone providing oversight. [Preceptor] left a couple of months after my promotion to NM and I thought I was doing fine. I got reports from QAPI and just reported out what I got.” The NM shared that she now has a better understanding and has developed a plan for keeping QAPI in compliance. Telephone interview with the Medical Director and AOD on 01/22/2024 at 1645, the Medical Director shared, “Most of the time, [AOD] and I are not there, and we depend on the NM to let us know when things need our attention.” Interview revealed the Medical Director was aware the NM had “a lot going on but was surprised when [AOD] told me about the survey, especially the lack of QAPI Committee and Governing Body meeting minutes. I’ve been in this area [dialysis] 30 years and have never had anything like this happen. This is also my fault, but we do depend heavily on the NM. I am very embarrassed and want you to know that this is not at all a reflection of the care that we provide for our patients.” The interview revealed the Medical Director was not aware that QAPI Committee meeting minutes and Governing Body meeting minutes were missing, that Action Plans had not been updated, or that Infection Control audit had not been completed per facility policies. Interview revealed the facility’s previous practice had been to review quality metrics without the printed QAPI Report with aggregated data and Action Plans but that going forward, the QAPI report would be printed for review by the interdisciplinary team during monthly QAPI Committee meetings and Governing Body meetings. “My expectation is that company policies and procedures are followed.””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 35306 Based on facility policy review, “Nursing Monthly Checklist” review, “FACILITY SAFETY INSPECTION” checklist review, Medisense and Embrace PRO Control Solution recommendations for use review, BD BACTEC Lytic/10 Anaerobic/F Culture Vials recommendations for use review, “Blood Glucose Meter Calibration” log review, medical record review, observation, and staff interviews, the facility’s nursing staff failed to use a new, sterile needle and syringe when accessing medication in a multi-dose vial following the facility’s policies and procedures in 1 of 3 observed patient prepared medications (Patient #5), failed to maintain the glucose control solution in accordance with the manufacturer’s recommendations for use for 2 of 2 sets of glucose control solutions (high and low solutions), failed to ensure that expired supplies were removed from storage with non-expired supplies for 2 of 2 blood culture vials, and failed to complete a nursing assessment after the hemodialysis treatment was completed for 1 of 4 patient records sampled (Patient #2). Findings included: 1. Review on 01/11/2024 of the facility’s policy titled, “Use of Multiple dose Vials” (no date) revealed, “... A new, sterile needle and syringe should always be used to access the medication in a multi-dose vial. The reuse of needles or syringes to access multi-dose vial medication can result in contamination of the medicine with microbes that can be spread to others when the medicine is used again.” Review of the facility’s “Nursing Monthly Checklist” revealed, “To be done by the NM monthly - turn in with QA [Quality Assurance] monthly ... 5. During Infection Control Audit, observe for compliance for administration of medications...” Review of the facility’s “FACILITY SAFETY INSPECTION” revealed, “... O. Drugs/Medications... c. expiration dates checked monthly.” Observation on 01/10/2024 at 1200 of parenteral medication preparation for Patient #5 revealed Retacrit (used to treatment anemia, a problem of not having enough healthy red blood cells or hemoglobin to carry oxygen to the body’s tissues) 5400 units was ordered. The CN pulled up the remains from a Retacrit multi-dose vial and needed additional medication to make the 5400 units. Observation revealed the CN used the same needle and syringe to access the medication in the newly opened Retacrit multi-dose vial. Interview during the observation at 1200 with the facility’s CN revealed “I have never used another syringe or needle to pull additional medication from a multi-dose vial. I did not know we were supposed to do that.” Interview with the AOD on 01/10/2024 at 1330 revealed facility policy was that a new syringe and needle should be used when accessing medication in a multi-dose vial. Interview with the NM on 01/12/2024 at 1745 revealed she was not sure what the policy was for use of multi-dose vials but that her expectation was that staff follow facility policy. Telephone interview with the MD and AOD on 01/22/2024 at 1645, the MD shared that he was “surprised” when the AOD notified him of the survey findings. The interview revealed the MD was not aware that the NM was not familiar with facility policies and procedures and that his expectation was that staff follow company policies and procedures. 2. a. Review of the facility guidelines titled, “Expiration Dates of Strips, Solutions and Meds” (no date) revealed, “ ... Glucose Hi/Lo Solution Should be discarded 90 days from date it was opened.” Review on 01/12/2024 of the Medisense Glucose and Ketone Control solutions packing recommendations for use revealed, “... Control Test ... Operating Guidelines for Control Solution Testing ... When opening a new bottle, write the discard date on the bottle label. Each bottle of control solution is stable for 90 days after opening or until the expiry date printed on the label, whichever comes first. Do not use control solutions after expiry date printed on the bottles and the box. After the bottle has been opened, do not use after the discard date written on the bottle.” Observation on 01/12/2024 at 1042 of the designated lab area revealed a small plastic container that contained 4 glucometers and four opened bottles of control solutions (high and low). Observation revealed two bottles of Medisense Glucose and Ketone Control solutions (high and low) with an illegible handwritten open date on the label and an expiration date of 09/30/2023 (104 days past expiration date) printed on each bottle from the manufacturer. Interview on 01/12/2024 at 1100 with the NM during the observation revealed, “We use the product expiration date on the bottle and those expired 12/09/2023. He [designated personnel] must have missed that.” Interview revealed we will get some more ordered and get those replaced.” Interview confirmed findings. Interview on 01/12/2024 at 1215 with the AOD revealed that the glucose control solutions were only good for 90 days after the open date or the expiration date on the solutions themselves, whichever comes first. Telephone interview with the MD and AOD on 01/22/2024 at 1645, the MD shared that he was “surprised” when the AOD notified him of the survey findings. The interview revealed the MD was not aware that the NM was not familiar with facility policies and procedures and that his expectation was that staff follow company policies and procedures. b. Review on 01/12/2024 of the Embrace PRO Control Solution packing recommendations for use revealed, “...The control solution test confirms that your meter and test strips are working correctly... CAUTION ... Check the expiration date on the control solution vial. Do not use if expiration date has passed.” Observation on 01/12/2024 at 1042 of the designated lab area revealed a small plastic container that contained 4 glucometers and four opened bottles of control solutions (high and low). Observation revealed one bottle of Embrace PRO Low Control Solution 1, Lot Number: C22F0901 and one bottle of Embrace PRO High Control Solution 2, Lot Number: C22F0902 with an open date of 04/26/2023 written on each bottle and an expiration date of 12/09/2023 (227 days after the open date of 04/26/2023 written on each bottle). Review on 01/12/2024 at 1211 of the facility’s “Blood Glucose Meter Calibration” log revealed the High and Low control solutions, Lot Numbers: C22F0901 and C22F0902, were used for the “Blood Glucose Meter Calibration” on 12/11/2023, 12/13/2023, 12/18/2023, 12/20/2023, 12/22/2023, 12/24/2023, 12/27/2023, 12/29/2023, 01/01/2024, 01/03/2024, 01/05/2024, 01/08/2025, 01/10/2024, and 01/12/2024 (261 days after the open date of 04/26/2023 written on each bottle and 34 days or 14 treatment days past the expiration date of 12/09/2023). Interview on 01/12/2024 at 1100 with the NM during the observation revealed, “We use the product expiration date on the bottle and those expired 12/09/2023. He [designated personnel] must have missed that.” The interview revealed we will get some more ordered and get those replaced. Interview during review of the “Blood Glucose Meter Calibration” log revealed that based on the documented lot numbers used for the quality control tests from 12/11/2023-01/12/2024, expired control solutions had been used. Interview confirmed findings. Interview on 01/12/2024 at 1215 with the AOD revealed that the glucose control solutions were only good for 90 days after the open date or the expiration date on the solutions themselves, whichever comes first. Interview during review of the “Blood Glucose Meter Calibration” log revealed that it was not acceptable to use expired control solutions for the quality control test. Interview confirmed findings. Telephone interview with the MD and AOD on 01/22/2024 at 1645, the MD shared that he was “surprised” when the AOD notified him of the survey findings. The interview revealed the MD was not aware that the NM was not familiar with facility policies and procedures and that his expectation was that staff follow company policies and procedures. 3. Review on 01/12/2024 of the facility policy titled, “LABORATORY SUPPLY INVENTORY DATE ISSUED: 01/31/2023” revealed, “... Monthly Inventory: 1. Monthly the designated person will check all lab tubes for the expiration date of each box of supplies. 2. If expired materials are found, the item will be immediately removed from stock and disposed of ... NOTE: The Nurse Manager will monitor compliance with this policy during the last week of the month period compliance will be reported as a monthly quality assurance indicator. Review on 01/12/2024 of the BD BACTEC Lytic/10 Anaerobic/F Culture Vials manufacturer recommendations for use revealed, “... QUALITY CONTROL ... DO NOT USE culture vials past their expiration dates.” Observation on 01/12/2024 at 1042 in the facility’s dedicated lab area revealed a two (2) BD Bactec Lytic/10 Anaerobic/F Culture Vials, Lot Number: 2333856, (used for blood cultures) were stored with two (2) other blood culture vials in the cabinet below the centrifuge (used to spin blood down). The observation revealed that the two BD Bactec Lytic/10 Anaerobic/F Culture Vials had an expiration date of 09/30/2023 (three months, 12 days expired). Interview on 01/12/2024 at 1042 with the NM revealed “He [designated personnel] must have missed them.” The interview confirmed the observation finding. Telephone interview with the MD and AOD on 01/22/2024 at 1645, the MD shared that he was “surprised” when the AOD notified him of the survey findings. The interview revealed the MD was not aware that the NM was not familiar with facility policies and procedures and that his expectation was that staff follow company policies and procedures. 4. Review of the facility policy titled, “Patient Assessments: Post Dialysis CHRONIC” (1-10-2023) revealed, “... POLICY: Each patient will be assessed after the treatment is discontinued ...” Medical record review on 01/11/2024 for Patient #2 revealed a 73-year-old-male was admitted to the facility for ICHD on 05/12/2022. Review of the treatment flowsheet for 12/13/2023 revealed the patient received hemodialysis from 1155 to 1558 for a total of 4 hours and 3 minutes. Review of the “Physical Assessment (Post)” by the CN revealed the post-treatment assessment was performed at “02:34 PM” (1 hour and 23 minutes prior to the treatment end time). Interview on 01/12/2024 at 1744 with the NM revealed the CN was not available for interview and that post-treatment assessments should be completed after the hemodialysis treatment ended. Interview confirmed 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: 35306 Based on review of the Centers for Disease Control and Prevention (CDC) website, personnel files, and facility policy, and staff interview, the facility leadership failed to ensure staff demonstrate and sustain the skills needed to perform the specific duties of their positions and to serve the complex needs of dialysis patients for 1 of 3 personnel files reviewed (NM). Findings included: Review of the CDC’s webpage “Dialysis Safety . . . Staff Competencies,” on 04/21/2017, revealed “Assess staff upon hire and at least yearly in the following competencies . . . Gloving and hand hygiene . . . Catheter dressing change technique . . . Vascular access technique . . . “ Review of the Nurse Manager job description was requested 01/11/2024, 01/12/2024, 01/22/2024, and 02/07/2024 and was not provided. 1. Review on 01/12/2024 of the personnel file for the facility’s NM, date of hire 02/20/2017, revealed no “New Nurse Manager Orientation Guide” or annual competency checklist available for review. Review of a seven (7) page list of trainings completed by the NM revealed completion of trainings 2017-2019. Review of the personnel file failed to reveal evidence of demonstration or sustainment of competency. Interview with the facility’s NM on 01/12/2024 at 1744 revealed that she was hired in the role as NM in 2021 but did not fully understand the QAPI program or how to update Action Plans until working with the corporate nurse “sometime in June or July” of 2022. Interview revealed, “When I got this position, I was trained by someone with many hats, who was also training other staff in various positions, who got pulled away a lot. QAPI was a huge thing I didn’t understand. I sat in a couple of meetings [with the preceptor] and just didn’t get it.” Interview revealed, “I failed to reach out for help, I was overwhelmed and didn’t get an understanding of it [QAPI]. Then I went to a new NM training in November [2023] and got a better understanding of it.” Interview revealed, “I sat in those meetings every month but just did not understand my responsibilities. I did not know that I was supposed to do monthly Infection Control audits, but I do now.” The interview revealed the educator completes an IC audit annually and sends the information to the NM. The NM shared that she thought the annual IC audit was all that was required. Interview revealed, “I didn’t have anyone providing oversight. [Preceptor] left a couple of months after my promotion to NM and I thought I was doing fine. I got reports from QAPI and just reported out what I got.” The NM shared that she now has a better understanding and has developed a plan for keeping QAPI in compliance. Interview with the facility’s Nurse Educator on 01/12/2024 at 1845 revealed that she had been in the role since 12/2022 and could only speak to the organizations process since that time. The Educator shared that NMs are given the “New Nurse Manager Orientation Guide” during orientation and are responsible for getting it completed. Interview revealed, “I could not find the checklist [New NM Orientation Guide] in [NM] file.” Interview with the facility’s AOD on 01/12/2024 at 1855, revealed that she nor the educator were able to find the “New Nurse Manager Orientation Guide” checklist and that there was not an annual competency for the NM role within the organization. Telephone interview with the MD and AOD on 01/22/2024 at 1650, the MD shared the NM was sent to training and that the roles and responsibilities for the NM role were covered on the NM checklist [New Nurse Manager Orientation Guide]. When informed that the referenced checklist was not in the NM’s personnel file upon review on 01/12/2024, the MD stated, “I am very embarrassed and want you to know that this is not at all a reflection of the care that we provide to our patients.” During the interview, the AOD shared that the NM was sent to training and that NM duties and responsibilities were covered on the “Nurse Manager Orientation Guide”. The AOD also shared that there is not currently an annual competency evaluation for the NM role. “We need to have a checklist developed” she said. Interview confirmed findings.”