South Laburnum Dialysis LLC

“Names and Contact Information CFR(s): §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: 42929 Based on facility document review and interview with staff, it was determined that the facility failed to ensure the communication plan included an updated list of contact information. Findings: On February 24, 2025, the surveyor reviewed the facility’s emergency preparedness documentation provided by staff (EMP) 2. There was no documentation of the names and contact information for the patient’s physicians. On February 25, 2025, the surveyor requested the names and contact information for the patient’s physicians. EMP1 provided the surveyor with a list but the list failed to contain all of the providers who work at the facility, the name and contact information for the biomedical technician was for the previous biomed technician, not the current employee who had been in the position since in October 2024, and the social worker contact information was blank. EMP1 indicated that there have been new employees and this list needed to be updated. Later in the day EMP1 provided the surveyors with an updated list.”

“Primary/Alternate Means for Communication CFR(s): §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.542(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID’s staff, Federal, State, tribal, regional, and local emergency management agencies. This Standard is not met as evidenced by: 42929 Based on observation, facility document review and interview with staff, it was determined that the facility failed to have an alternate means for communicating with staff and emergency management agencies. Findings: On January 24, 2025, the surveyor reviewed the facilities emergency management plan and documentation. There was no documentation of the facility’s plan for alternate means of communication with staff and emergency management officials. On January 25, 2025, at 9:38 AM, EMP2 provided the surveyor with a box labeled “All Purpose Weather Radio and Phone Charger” and stated that this was the facility’s communication device. EMP2 did not provide the surveyor with any documentation of the facility’s alternate communication plan or policy and stated the “red radio” was the facility’s alternate means of communication.”

“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: 42929 Based on three (3) infection control observations, facility document review and interview with staff (EMP), it was determined that the facility failed to ensure cleaning and disinfecting of contaminated surfaces and equipment. Findings: The facility’s policy titled “G45 Cleaning and Disinfection of Equipment, Supplies and Treatment Area” last revised June 20, 2024, states in part: ... All routinely touched reusable equipment and surfaces in each patient’s treatment area must be disinfected after each patient’s treatment. Caregivers will ensure that cracks/crevices come in contact with the bleach solution. This includes, but is not limited to the: ... chair, including the top and bottom of the chair-side table(s) ... counters and wall boxes ... 8. Dialysis chairs will be reclined, and all areas inspected and disinfected where blood could accumulate and not be readily noticed.... On February 24, 2025, at 2:56 PM, EMP10 did not put down the side tables, open the chair arms, wipe the chair thoroughly, or wipe the blood pressure cuff when cleaning station 17. On February 24, 2025, at 3:10 PM, EMP9 did not wipe the sides of the chair underneath the side tables when cleaning station 5. After cleaning the chair, EMP9 placed new supplies on the chair, although the machine at that station had not been cleaned. On February 24, 2025, at 3:44 PM, EMP13 moved the vinegar jug from the base of clean station 12 to the base of the machine at station 13 that had not been cleaned after the last patient’s treatment. During an interview on February 25, 2025, at 10:03 AM, EMP3 indicated that clean supplies should not be brought to the dialysis station until the entire dialysis station is cleaned. During an interview on February 25, 2025, at 10:50 AM, EMP1 indicated that the entire dialysis station should be cleaned before any new supplies are brought to the station. EMP1 indicated that vinegar jugs used for internal cleaning of the machine should only be placed on the base of clean machines.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 42929 Based on observations, interview with staff and facility document review, it was determined that the facility staff failed to ensure aseptic technique when preparing and administering medications. Specifically, the facility failed to include all of the necessary components of medication labeling and failed to remove expired medications from use. Findings: The facility’s policy titled “G48 Medications: Handling, Administration, Storage & Disposal” last revised January 13, 2025, states in part: ... 10. Multi-dose medication vials shall be labeled with the date the vial is first entered and the initials of the person who first entered the vial.... 14. Any medication drawn up before the time it is to be administered shall be labeled with: ... date/time medication was drawn up and initials of nurse who drew up the medication.... 40. Expired medications ... are immediately removed form the treatment and inventory areas and disposed of per state/local regulations.... The facility’s policy titled “G40 Infection Control” last revised November 29, 2022, states in part: ... 18. Multi-dose medication vials will be labeled with the date they are first entered and initialed by the center associate opening the vials.... 23. Medications ... drawn up and stored prior to administration ... must always be clearly labeled with the following information: ... date and time medication was drawn up, initials of the nurse who drew up the medication. On February 24, 2025, at 9:18 AM the surveyor observed five (5) expired saline syringes in the code cart with an expiration date of January 31, 2025. The surveyor observed one (1) open vial of heparin with no date that the vial was open or initials of staff that opened the vial. At 9:40 AM the surveyor observed heparin filled syringes for five (5) patients, Patient (MR) 4, MR6, MR8, MR9, and MR10, with no time that the medication was drawn up. EMP2 was given the expired saline syringes and notified they were expired. During an interview on February 25, 2025, EMP2 confirmed that the opened multi-dose vial should be dated and initialed by the staff opening the vial and the the heparin filled syringes should be labeled with the time the medication was drawn up.”

“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: 42929 Based on observations, review of facility documents and interview with staff, it was determined that the facility failed to ensure aseptic technique when providing dialysis treatment to one (1) of two (2) patients (MR17) with a CVC (central venous catheter). Findings: The facility’s procedure titled “IC05C CVC: Dressing Change” last revised September 1, 2023, states in part: ... 3. Remove the old dressing from the catheter site and discard with contaminated gloves. Hand hygiene don new gloves.... On February 24, 2025, at 12:00 PM, EMP13 was performing a CVC dressing change for MR17 at station 12. EMP13 removed the old dressing, did not change gloves, and proceeding to clean the access site. During an interview on February 25, 2025, at 10:03 AM, EMP3 indicated that the staff must remove the dressing and then change gloves, perform hand hygiene, and don new gloves prior to cleaning the site. During an interview on February 25, 2025, at 10:50 AM, EMP1 confirmed that staff must change gloves and perform hand hygiene after removing the old CVC dressing and prior to cleaning the site.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 49355 Based on observations, interview and document review, it was determined the facility staff failed to maintain a safe environment by not disposing of contaminated sharps at the point of use in one (1) out of two (2) observations when deaccessing patients with a fistula or graft. The findings include: The facility’s document entitled, “RM100 Bloodborne Exposure Control Plan,” last revision date December 22, 2023, reads in part: “... Specified Control Methods ... B. Engineering Controls ... 6. Sharps include, but are not limited to needles, fistula needles...that has or may have come into contact with blood or body fluids. ... 7. Disposable sharps will not be reused and must be discarded as soon as possible into containers that can be closed and are puncture-resistant and leak-proof on the sides and bottom.” At 9:40 A.M. on February 24, 2025, EMP13 deaccessed MR2’s fistula at station #12. EMP13 placed both contaminated needles on the chairside table before eventually disposing of them in the adjacent Sharps container. During an interview on February 25, 2025, at 10:35 A.M., EMP3 indicated that contaminated needles should be placed immediately into a Sharps container. During an interview on February 25, 2025, at 10:50 A.M., EMP1 indicated that when deaccessing a fistula, each needle should be discarded in a Sharps container immediately.”

“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: 42929 Based on review of medical records, facility document review and interview with staff, it was determined that the facility staff failed to document why the prescribed blood flow rate (BFR) was not followed and the actions taken to address the situation as per the facility’s policy for four (4) of five (5) patients’ flow sheets reviewed (MR11, MR13, MR14, MR15). Findings: The facility’s policy titled “IC08 Monitoring and Documentation of Patient Care During Treatment” last revised November 29, 2022, states in part: ... 15. Information that must be entered manually includes, but is not limited to: ... interventions for unexpected situations, such as slowing blood flow for access problem ... if the patient’s prescription was not met for any reason (A detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation) ... On February 25, 2025, the surveyors reviewed the six (6) most recent dialysis treatment flow sheets for five (5) in-center hemodialysis patients, MR11, MR 12, MR13, MR14, and MR15. Dialysis orders for blood flow rate (BFR) were not followed in four (4) of the five (5) patients’ flow sheets reviewed. There was no documentation explaining why the prescription was not met and actions taken to address the situation as per the facility’s policy for the following: MR11 December 2, 2024 - BFR documented at 400 ML/min when the prescribed rate was 450 ML/min; MR13 December 13, 2024 - BFR documented at 400 ML/min when the prescribed rate was 450 ML/min; December 23, 2024 - BFR documented at 375 ML/min when the prescribed rate was 450 ML/min; MR14 February 24, 2025 - BFR documented at 450 ML/min when the prescribed rate was 500 ML/min; MR15 February 12, 2024 - BFR documented at 400 ML/min when the prescribed rate was 450 ML/min; February 19, 2024 - BFR documented at 400 ML/min when the prescribed rate was 450 ML/min; During an interviews on February 25, 2025, EMP2 confirmed that the reason for the change in the prescription and notification to the nurse should be documented in the flow sheet.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 49355 Based on observations, interviews, and document review, it was determined the facility staff failed to aseptically access an arteriovenous (AV) graft/fistula according to facility policy in two (2) out of three (3) observations (MR6 and MR7). The findings include: In the facility’s policy entitled, “IC04 Cannulation & Treatment Initiation with AVF/AVG,” last revision date April 2023, reads in part: “Purpose: ... To decrease the risk of infection via the access. ... Policy: 1. Standard Precautions, Aseptic Non-Touch Technique (ANTT), use of appropriate personal protective equipment (PPE) and all other applicable Innovative Renal Care (IRC) infection control policies and procedures will be used when fistula needles are placed, repositioned and removed.” In the facility’s policy entitled, “G40 Infection Control,” last revision date November 29, 2022, reads in part: ... “Policy: 1. Standard precautions and infection control measures as outlined in this policy will be used by all associates at all times. 2. All IRC [Innovative Renal Care] associates will be trained regarding IRC policies and procedures for infection control. ... 30. Aseptic technique will be used to prepare the access site prior to needle insertion..... ... 31. All blood line, fistula needle and CVC connections will be handled using proper aseptic technique.” At 11:25 A.M. on February 24, 2025, at station #2, EMP9 was observed attempting to access the fistula on MR6. EMP9 cleansed the area with antiseptic and then palpated the area prior to inserting the needle, without recleansing. EMP9 encountered problems with the access and EMP2 attempted to reposition the needle, but could not get the site to flush. EMP2 removed the needle, palpated the site and reaccessed, without performing antisepsis after palpating the area. At 11:45 A.M. on February 24, 2025, at station #19, EMP10 was observed cleansing the fistula site of MR7, palpating the area and inserting the needle, without recleansing the site. During an interview on February 25, 2025, at 10:35 A.M., EMP3 indicated that a fistula site should be recleansed with an antiseptic after palpating and before accessing the site. During an interview on February 25, 2025, at 10:50 A.M., EMP1 indicated that a fistula site that has been palpated must be recleansed with an antiseptic before inserting the needle.”

“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: 42929 Based on interviews with staff and facility document review, it was determined that the facility failed to document an adverse incident in the facility’s incident reporting system. Findings: The facility’s policy titled “Clinical Incident Review and Reporting” last revised April 1, 2022, states in part: ... To ensure quality care and oversight of its clinics, and to protect the health and safety of and minimize risk of harm to patients and staff, [the facility] requires review and, at times, reporting of incidents that occur at its clinics. “Incident” means an occurrence that involves a person and requires the clinical staff to involve themselves or respond in a way that is not typical in the ordinary provision of services to that patient. All incidents must be reported through [the facility’s] incident reporting system, and the incident report should be submitted within 24 hours of the occurrence of the incident ... During a telephone call on February 24, 2025, at 10:04 AM the complainant notified the surveyor the facility staff was notified by MR11’s spouse that the staff did turn on the patient’s portable oxygen prior to the patient leaving the facility after dialysis treatment on December 4, 2024. The spouse notified staff that the patient passed out in the car. During an interview on February 25, 2025, at 10:03 AM, EMP3 indicated that MR11’s spouse called the clinic stating that the spouse “almost lost” the patient because the patient’s oxygen was not turned on upon leaving the facility. MR11 requires oxygen twenty four hours a day, seven days a week. EMP3 told the spouse that EMP3 would discuss the incident with the technician. EMP3 did not submit an incident report in the facility’s incident reporting system, but had notified EMP1 about the incident. During an interview on February 25, 2025, at 10:50 AM, EMP1 was aware that MR11 had been sent home after treatment without the patient’s portable oxygen turned on. EMP1 did not hear from the patient or the patient’s spouse directly, but was “disturbed” to hear about incident. EMP1 indicated that the incident was not documented in the facility’s incident reporting system. EMP11 indicated that it is the staff’s responsibility to ensure the patient is hooked up to oxygen and it is turned on prior to leaving the facility, so the incident should have been reported in the facility’s incident reporting system.”

“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: 42929 Based on observations, facility document review and interview with staff, it was determined that the facility failed to follow policies and procedures related to social workers’ quarterly progress notes and the use of spray cleaner bottles in the facility. Findings: The facility’s policy titled “Social Worker Progress Notes” last revised January 1, 2019, states in part: ... Quarterly Progress Note. Once a patient is stabilized, the social worker must meet with the patient at least quarterly and document their status in the social work progress note.... The surveyors reviewed the medical records for five (5) patients, MR11, MR12, MR13, MR14, and MR15. The medical records provided for MR11 revealed that the last social worker note for this patient was documented on June 26, 2024, and the patient’s last treatment day at the facility was December 9, 2024. The medical records provided for MR12 revealed the last social worker note for this patient was documented on May 17, 2024, and this patient was still receiving treatment at this facility. (B) The facility’s policy titled “G45 Cleaning and Disinfection of Equipment, Supplies and Treatment Area” last revised June 20, 2024, states in part: ... Use of spray bottles is prohibited ... All routinely touched reusable equipment and surfaces in each patient’s treatment area must be disinfected after each patient’s treatment. This includes, but is not limited to the: ... counters and wall boxes ... During an interview on February 24, 2025, at 3:52 PM, EMP13 believed that the wall boxes get cleaned with the station after each patient’s dialysis treatment. EMP13 indicated that EMP13 had three stations that were cleaned that still needed the wall boxes cleaned. EMP13 indicated that the staff spray the wall boxes with vinegar to help clean build up from the bicarb. EMP13 proceeded to spray the wall box at station 16. There was a patient receiving treatment in the chair next to that station and other patients still receiving treatment in the facility. During an interview on February 25, 2025, at 10:03 AM, EMP3 indicated that the staff are not supposed to use the spray bottles with vinegar when patients are in the facility. The spray bottle containing vinegar is used to clean the wall boxes. Recently the staff were told to store the spray bottles containing vinegar in the biomed technician’s office and not on the treatment area when patients are present. EMP3 has used the spray bottle containg vinegar to clean at night. EMP3 was “unclear” of the policy for the use and storage of the spray bottles containing vinegar. During an interview on February 25, 2025, at 10:50 AM, EMP1 indicated that the spray bottle containing vinegar is used to knock down bicarb from the wall boxes at the end of the night, but the wall boxes should be cleaned with bleach after each patient treatment. EMP1 did not believe they should use the spray bottle containing vinegar while patients were in the facility and was unaware of a policy related to the use and storage of spray bottles containing vinegar. On February 25, 2025, at 2:01 PM, EMP2 indicated that there was no facility policy for use of the spray bottle containing vinegar. EMP2 indicated that the spray bottle containing vinegar can be used to spray the wall box if there is no patient in that specific treatment chair. EMP2 then provided an email that referred to the facility’s biomedical monthly checklist that refers to external surfaces of the acid/bicarb distribution system should be sprayed with vinegar and wiped down. EMP2 confirmed that there is confusion among the staff about the use of the spray bottle containing vinegar.”

“GOV-ELECTRONIC DATA SUBMISSION REQUIRED CFR(s): 494.180(h) (8) Effective February 1, 2009, the dialysis facility must furnish data and information to CMS and at intervals as specified by the Secretary. This information is used in a national ESRD information system and in compilations relevant to program administration, including claims processing and reimbursement, quality improvement, and performance assessment. The data and information must- (1) Be submitted at the intervals specified by the Secretary; (2) Be submitted electronically in the format specified by the Secretary; (3) Include, but not be limited to- (i) Cost reports; (ii) ESRD administrative forms; (iii) Patient survival information; and (iv) Existing ESRD clinical performance measures, and any future clinical performance standards developed in accordance with a voluntary consensus standards process identified by the Secretary. This Standard is not met as evidenced by: 49355 Based on interview and document review, it was determined the facility failed to comply with reporting an End Stage Renal Disease (ESRD) patient’s death to Centers for Medicare and Medicaid Services (CMS) within 2 weeks, per CMS regulations. The findings include: A review of the CMS Form 2746 entitled, “ESRD Death Notification,” with an expiration date of March 31, 2027, reads in part: “Complete this ESRD Death Notification form within 2 weeks of the date of death. If the patient was a dialysis patient, the dialysis facility last responsible for the patient’s maintenance dialysis ...must complete this form.” The date of death for MR16 was July 31, 2024. Form #2746 was completed and submitted to CMS on September 11, 2204. During an interview on February 25, 2025, EMP2 indicated that the form should be completed and submitted within 7 days. EMP2 contacted EMP6 to confirm that CMS Form 2746 should be completed and submitted to CMS within 7 days of a ESRD patient’s death. The surveyor requested a facility policy outlining the steps and timeline to complete and submit Form 2746. EMP2 stated the facility did not have a policy. EMP2 indicated that the Social Worker is responsible for completing and submitting the form.”