Kalkaska Dialysis Center

“CFC-CARE AT HOME CFR(s): 494.100 This Condition is not met as evidenced by: 50585 Based on interview and record review, the facility failed to provide comprehensive home dialysis services for 1 (P-5) of 1 home peritoneal dialysis (PD) patients at the dialysis facility (Facility A) resulting in the less-than-optimal outcomes for the home patient. Findings include: On 6/12/2025 at 0910, the facility’s policies for peritoneal dialysis (PD) were requested. Clinic Manager Staff A revealed that the Coordinator for Home Dialysis would bring the policies from an offsite location. On 6/12/2025 at 1020, P-5’s medical record was requested and Staff B revealed that the “PD records” were “kept at another ESRD (Facility B), which was under a different CMS Cettification Number (CCN)” and the Coordinator for Home Dialysis Staff K would bring the medical record from Facility B. Staff B confirmed the medical records were stored at Facility B. Staff B also revealed that PD Nurse personnel file was requested, and they had to ask the off-site facility (Facility B) for the file. On 6/12/2025 at 1245, Home Coordinator Staff Nurse Staff K was queried about the training of new PD patients. They responded that training occurs at Facility B. After setting up and training, the patient would complete five CAPD (Continuous Ambulatory Peritoneal Dialysis) training’s at Facility B and would come back to Facility B for a couple of “cycler” training’s then start up at home. Patients come in twice each month to a facility either at the Facility B or here (Facility A). The comprehensive treatment assessments (CTA) were “pretty much here (Facility A).” When queried about how treatment sheets were reviewed, Staff K revealed that the patient would complete treatment sheets and every “cycler” had a “modem” to upload the treatment sheet data but still had the patient document. Staff K revealed that “someone” at Facility B was assigned to review the sheets daily and they “don’t look on weekends” and the “patient is supposed to bring treatment sheets with them.” When queried what number do patients call in case they need assistance, Staff K revealed the switch board at Facility D (hospital with a different CCN) and all emergencies go through the switchboard and the Home RN would call back. On 6/13/2025 at 0900, PD Nurse Staff L was interviewed, and they revealed that laboratory work was performed at Facility B and clinic visits were held wherever the “patient was established.” PD patients were expected to go to Facility B for their laboratory work. The facility staff provided a key personnel list for the recertification survey, and PD Nurse Staff L was not on the list. On 6/12/2025 at 1440, Social Worker Staff E was interviewed and revealed that for the PD program nurses were contracted (Nurses from Facility B provide PD nursing). On 6/13/2025 at 1036, P-5 was queried why they go to another facility (Facility B) for laboratory work and not this dialysis facility (Facility A) and the family member of P-5 stated “we were told we can’t” and stated it will be easier to do labs here at (Facility A).”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 36887 Based on observation, interview, and record review the medical director failed to develop facility policies specific to this facility (Facility A) and failed to ensure compliance with current policies and procedures for disposal of expired supplies and storage of vaccines resulting in the potential for less than optimal outcomes for the 35 in-center patients and 1 home peritoneal dialysis patient served by the facility. Findings include: See Specific Tags: V-714 Failure to develop policies and procedures specific to Facility A V-715 Failure to ensure current policies and procedures were followed regarding disposal of expired supplies and storage of vaccinations”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 36887 Based on interview and record review, the governing body failed to establish contracted services for the dietician and the home peritoneal program specific to the facility (Facility A) resulting in the potential for less than optimal outcomes for all patients served by the facility. Findings include: On 6/12/2025 at 1020, Staff B stated the dietician was provided by contract with a management company and there was an affiliation agreement between Facility A and Facility B (an ESRD with a different CMS certification number/CCN). She further stated Facility A was owned by the nearby local hospital (Facility C, also with a different CCN). The contracts were requested for review. On 6/12/2025 at 1335, the contract for dietetic services was reviewed and revealed the contract was between Facility C (the local hospital) located next door to Facility A and a management company. Further review of the contract revealed there was no mention of services to be provided directly to Facility A. On 6/13/2025 at 1045, review of the affiliation agreement revealed the agreement was between hospital Facility C and Facility D (hospital in a larger nearby city), and lists “dialysis service management” but was not specific as to if it were for inpatient services, outpatient services, or both. For home dialysis, the estimated budget/cost was transferred to the local hospital, not the dialysis center. Mileage reimbursement was stated between Facility B and Facility A. This was the only reference present that was made regarding Facility A. The agreement continued to define budgeting and services for other hospital departments within Facility C. Neither Facility A, B, C, or D shared the same CCN. On 6/13/2025 at 1155, during the exit conference, concern was mentioned that the dialysis center (Facility A) was being treated as though it were a unit of the local hospital (Facility C) to which Kalkaska Director Staff D stated, “It is.””

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 36887 Based on observation, interview, and record review, the facility failed to have emergency equipment immediately available for use resulting in the potential for 8 of 8 patients currently dialyzing to have poor outcomes up to and including death in the event of an emergency. Findings include: During the initial tour of Facility A on 6/11/2025 at 0910, the clean supply room was entered and a clean supply cart identified by Staff A as being the emergency evacuation cart was observed sitting in the back left corner with an oxygen tank in a rolling oxygen cart, 3 intravenous (IV) poles with IV pumps attached, a utility cart and the Hoyer lift all stored in front of it. This was confirmed by Staff A at the time of discovery. Upon opening the evacuation cart, it was noted it was unsecured and there were 3 bags of saline present in the bottom drawer. On 6/11/2025 at 0912, Staff A was queried as to why the evacuation cart was unsecured to which she stated there were no medications present. She was then queried as to how she could know the supplies had not been removed or tampered with to which she stated regular checks were done on the cart. On 6/11/2025 at 0915, a clean supply cart identified by Staff A as being the crash cart was observed on the treatment floor near the nurse’s station. The cart did not have an oxygen tank present on it and was unsecured. This was confirmed by Staff A at the time of discovery who stated the oxygen tank was in the clean supply room next to the evacuation cart. She further stated it was stored there because she did not want people “tripping over it.” It was noted the oxygen tank was immediately in front of the evacuation cart in the clean supply and had 3 IV poles with pumps attached, a supply cart, and the Hoyer lift in front of it. She further stated there were no medications in the crash cart. Facility policy #16211980 titled “Kalkaska Dialysis Center Disaster and Emergency Readiness Plan” effective 12/2/2024 states, “Emergency Evacuation Cart will be maintained for use in case of an emergency evacuation. Evacuation bags/boxes will be removed by a designated staff member to the safe area and will provide clinical staff the necessary material to safely and adequately treat and assess patients whose dialysis treatments were interrupted due to unforeseen circumstances. The emergency evacuation cart will contain enough supplies to care for one (1) full shift of patients. It will be stored in a location convenient to emergency exits on easy removable cart.” A policy was requested for what supplies were to be kept on the crash cart, when checks should be conducted, and if the cart should be secured. The provided policy titled “Documenting Code Status/Code Blue in the Outpatient Dialysis Facilities” did not address the supplies, checks or security of the cart. Additionally, another policy titled “Code Blue Cardiopulmonary Resuscitation” was provided which did speak of readiness, security, and supplies; however, it was very specific to the hospital setting and not dialysis. On 6/11/2025 at 1600, Staff A was queried as to why a hospital policy was provided to which she stated, “If we don’t have unit specific policies, we rely on hospital policy.””

“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: 36887 Based on observation and interview, the facility failed to ensure that all staff wear personal protective equipment (PPE) properly in the treatment area, resulting in the potential to spread infectious agents among the 8 patients receiving dialysis treatment at the time of observation. Findings include: On 6/11/2025 at 0945, Staff G was observed at station #2 administering a medication with the PPE gown loosely tied at the neck but falling forward exposing her upper arms and back. On 6/11/2025 at 1003, Staff G was observed at station #12 taking a patient off dialysis with the PPE gown loosely tied at the neck and falling forward exposing her arms and back. On 6/11/2025 at 1225, Staff G was observed at station #7 administering a medication with the PPE gown loosely tied at the neck but falling forward exposing her upper arms and back. On 6/11/2025 at 1230, an interview with Staff G revealed that she was aware that the PPE gown needed to provide full coverage while performing patient care but if she is doing something quick she doesn’t always tie the back and it might fall forward. On 6/11/2025 at 1615, Staff G was observed taking a patient out to the lobby via wheelchair to await his transportation. Staff G walked into the lobby wearing her gown, gloves, and had a face shield on top of her head. On 6/12/2025 at 1529 an interview with the facility Medical Director was conducted. When queried if it was appropriate for employees to administer care to patients without wearing appropriate PPE, Staff J responded, “no”. When queried if it is his expectation that facility staff following the policy related to Infection Prevention and appropriate donning appropriate PPE while administering care, Staff J responded, “without question”. Review of facility policy titled “Dialysis Center Infection Control - Employee Safety”, policy #17490158, last revised 3/6/2025 on page 2 under Protective Equipment, “A. The following protective equipment is be used in the dialysis treatment area: 2. Waterproof gown available in tech room.”. Page 3 under Employee Gowns, “A. Fluid resistant gown. B. Covered arms and be closed in front. C. Gown must be removed if it becomes soiled or wet. D. Gown must be removed prior to leaving the unit and for breaks and lunch. E. Be worn when there is a likelihood of body fluid contact, i.e. initiating/discontinuing dialysis, drawing labs, giving intravenous (IV) medications during dialysis, reversing blood lines, repositioning fistula needles. F. Cleaning and disinfecting equipment post dialysis. G. Patient has any draining wounds, incontinence, or secretions.””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 50585 Based on observation, interview, and record review, the facility failed to ensure clean supply items were stored separately from dirty areas for 1 of 6 observations resulting in the potential for adverse effects for the 8 patients receiving treatment at the time of observation. Findings include: On 6/11/2025 at 1200, Technician Staff H was observed placing individual strips of medical tape (clean) on the edge of tray (dirty) at the dialysis station #5. Technician Staff H was then observed removing the strips of medical tape and applying the medical tape directly to the patients skin to support a bandage. Staff H was immediately queried and they revealed that the tray was considered “clean,.” On 6/11/2025 at 1215, Clinic Manager (Infection Control Nurse) Staff A was queried whether the practice for placing medical tape directly on the dialysis station tray without a barrier was acceptable and they revealed that was the “way we are doing it.” According to the facility’s policy “Infection Control - Dialysis Center,” dated 12/8/2023, “Clean supplies/equipment is to be separated from contaminated areas.””

“ACID CONC MIX SYS-EMPTY ALL/PREV CORROSION CFR(s): 494.40(a) 5.4.4.2 Acid concentrate mixing systems: empty completely/prevent corrosion Acid concentrate mixing tanks should be designed to allow the inside of the tank to be completely emptied and rinsed according to the manufacturer’s instructions when concentrate formulas are changed. Acid concentrate mixing tanks should be emptied completely before mixing another batch of concentrate. Because concentrate solutions are highly corrosive, mixing systems should be designed and maintained to prevent corrosion. This Standard is not met as evidenced by: 38905 Based on observation and interview, the facility failed to maintain the acid system to be free from spills and reduce to risk of corrosion. This resulted in an increased risk of accidents, breakdown of equipment, and contamination, with a possible decrease in the safety of patients. This deficient practice has the potential to affect all patients. Findings Include: During a tour of the water room, with Bio-med “I”, on 6/12/25 at 08:40, it was observed that salt deposits and debris accumulation were evident on the tops and sides of the 2k and 3k acid tanks. Further observation found the tanks sitting directly on the floor with a flat bottom and no conical or bowl-shaped base to allow for easy emptying. Observation of the recirculation pumps for the acid tanks were also stored on the floor with heavy accumulation of salt on the outside of the pump’s fittings, indicating a slow leak. An interview with Bio-med “I”, on 6/12/25, at 08:43, found that there was a plumbing issue a few weeks back that lead to one of the recirculation pumps spraying acid all over this area, and although most of it was cleaned and attended to, some of the residual salt and debris accumulation is from that event. When asked if there was a reason the pumps and tanks were stored directly onto the floor, Bio-med “I” was unsure, but stated this was the original set up when built in 2007. When asked if the acid tanks and recirculation pumps on the floor have caused issues as staff perform their general duties, Bio-med “I” stated that it has caused issues in the past due to how easy it is to bump or step on the plumbing while working around the room. Bio-med “I” stated that recently he created a pinhole leak in one of the acid lines while trying to work in a tight space. Observation of the front left corner of the water room, on 6/12/25 at 08:47, found an eye wash station plumbed so that water dispenses onto the floor, despite having a mop sink basin roughly 12 inches away. Routine flushing of the eyewash station causes needless water to run onto the floor of the water room into the main floor drain and could delay the attention of repairs due the regularity of water being on the floor.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 36887 Based on interview and record review, the facility failed to identify 1 (P-2) of 2 patients reviewed for instability resulting in the potential for unrecognized, unmet patient needs and poor patient outcomes. Findings include: On 6/11/2025 at 1300, review of the “CIA (Comprehensive Interdisciplinary Assessment) Determination Meeting” for the past three months was reviewed. The meeting minutes from March 2025-present revealed on March 18, 2025, no patients were listed as unstable; however, in parenthesis underneath it stated, “(P-2 last name) if he returns to the clinic in time, or complete next month.” On 4/29/2025, P-2’s name was found under initial plans of care that needed to be reviewed with a date for the plan of care meeting listed as 5/20/2025. There was no indication that P-2 should be considered unstable. On 6/11/2025 at 1600, review of the hospitalization log revealed P-2 had been admitted to the hospital from 3/9/2025-4/7/2025 for a possible viral illness. Review of P-2’s medical record revealed plans of care from 2/24/2025 and 5/20/2025; however, no plan of care was present in April 2025 making the patient unstable. On 6/13/2025 at 0842, Staff A was queried as to why P-2 was not made unstable as he had been in the hospital for more than 15 consecutive days to which she stated the patient was not unstable because the last couple of weeks he was in the hospital, he was waiting for placement to a rehab facility. Facility policy #16995103 titled “Dialysis-Comprehensive Assessment Process” effective 11/26/2024 states, “When a patient is deemed unstable per CMS [Centers for Medicare and Medicaid Services] criteria (Standard V-520), a ‘comprehensive reassessment and a revision of the plan of care must be conducted within 30 days for unstable patients’... Unstable criteria may include: Extended or frequent hospitalizations...””

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 36887 Based on interview and record review, the medical director failed to provide a policy or procedure specific to this facility (Facility A) regarding supplies, security, and checks for the emergency evacuation cart, the emergency crash cart, daily review of the home treatment documentation, and the proper storage of vaccinations resulting in the potential for ineffective response in an emergent situation and ineffective vaccinations for all patients and/or staff served by the facility. Findings include: On 6/11/2025 at approximately 0930, policies were requested regarding supplies, security, and periodic review for the emergency evacuation cart and the emergency crash cart. On 6/11/2025 at 1251 a policy titled “Documenting Code Status/Code Blue in the Outpatient Dialysis” was provided. The policy failed to include what supplies were to be in the cart and the security of the cart, nor did it address how frequently the cart should be checked. On 6/11/2025 at 1335 a policy titled “Kalkaska Dialysis Center Disaster and Emergency Readiness Plan” was provided. The policy did address the fact that enough supplies should be present to care for 1 full shift of patients; however, the supplies needed were not defined, the security of the cart was not addressed, and how often the cart should be checked for content was not addressed. On 6/11/2025 at approximately 1400, Staff B was informed the policies provided did not address the supplies, security, and how often the cart should be checked. She stated she would find the policy and provide it. On 6/11/2025 at 1536, a policy #14129952 titled “Code Blue Cardiopulmonary Resuscitation” effective 8/13/2024 was provided. The policy did not apply to the dialysis clinic and was specifically related to emergencies within a hospital. It stated, “All mobile crash carts are to be checked monthly and when opened at ay time, checksheets will be initialed by the night shift and/or shift using the cart. The crash cart checklist will be initialed to indicate that the cart is stocked and locked and that the following equipment is present: Defib (sic)/Pacer, Ambu-bag, O2 tank and flow meter, oxygen tubing, resuscitation mask, backboard, suction device and clipboard with Code Blue form. 2. The Defibrillator/Pacer must be plugged in all the time and monitored for successful daily self-check. 3. The Defibrillator/Pacer will be checked for readiness weekly per Zoll Lippincott procedure and daily for automated testing. If testing fails, staff will complete a weekly test. If it continues to fail, staff will contact BioMed. 4. Medications will be checked monthly for expiration dates by the designated department representative. C. Crash Cart Restocking 1. Nursing personnel will ensure the crash cart is restocked. 2. Whenever a crash cart is unlocked or found unlocked, an inventory should be taken and refilled, if necessary. Relock the crash cart as soon as missing medications/IV’s (intravenous) are replaced. 3. Extra Code Med Tray can be found in the facility Pyxis machines. If a code tray is used, order another tray from the pharmacy to replace the Pyxis tray. Return the used tray with a code tray slip and patient sticker to the pharmacy so they can enter charges and restock the tray...The cart must be kept in a secure area until the cart is restocked and locked.” On 6/11/2025 at 1600, Staff A was queried as to why a hospital policy that did not in any way apply to the dialysis center was provided to which she stated, “If we don’t have unit specific policies, we rely on hospital policy.” On 6/12/2025 at 0915, all policies provided by Facility A were reviewed and noted to be on letterhead from Facility B (hospital) with a differnt CMS Certification Number (CCN), not on letterhead from Facility A. On 6/12/2025 at 1539, Medical Director Staff J stated he does review policies and has input into them. He stated when gaps were identified, then policies were developed. He did not agree that the facility would fall back to hospital policy if no policies were available. 50585 On 6/12/2025 at 1045, Coordinator Home Dialysis Staff K was asked about the process to review the patient’s treatment sheets. They revealed there was a nurse at the off-site faciltiy and that someone was “assigned to review the sheets daily” and they “don’t look on weekends” but “someone” was “on call 24 hours.” On 6/13/2025 at 0900, Home Nurse Staff L was queried if it was an expectation to review the treatments sheets daily and they said “yes.” When queried if there was a policy, they revealed they were “not aware of any policy.” On 6/13/2025 at 1010, Clinic Manager Staff A was asked for the policy for the review of treatment sheets for home dialysis patients. On 6/13/2025 at 1200, an exit meeting was performed with facility staff and the facility failed to provide a policy on daily monitoring of patient treatment sheets for patients on home peritoneal dialysis.”

“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: 50585 Based on observation, interview and record review, the facility failed to remove outdated supplies from the patient care area, safely store medication vaccines in the refrigerator, and appropriately assign expiration dates to unopened and opened multidose vials of injectable medications resulting in the increased likelihood of negative consequences for the all patients. Findings include: During a tour of the facility’s treatment area: On 6/11/2025 at 0900, a bottle of blood leak test strips was observed on the counter, available for use, and the manufacturer’s expiration date of the bottle was 12/31/2024. Technician Staff H confirmed the findings at the time of discovery. According to the facility’s policy “Clean and Sterile Supply Storage,” dated 4/29/2024, “Items that have a manufacturer’s expiration date are to be considered expired once the specified date has arrived.” On 6/11/2025 at 0910, during observation of the contents inside the medication refrigerator, a box of hepatitis B vaccine was stored on the shelf of the door of the refrigerator. System Director Staff B confirmed the findings that the vaccines were stored on shelf of the refrigerator door. On 6/11/2025 at 1215, IC Nurse Staff A was queried whether the facility followed CDC (Centers for Disease Control) guidelines for handling medication and they said “yes.” According to the facility’s policy “Storage and Handling Requirements for medications (Housewide), dated 12/15/2022, “Provisions for medication storage and security comply with all applicable federal, state, professional rules and regulations, and accepted pharmaceutical standards of practice.” According to the U.S. Department of Health and Human Services Centers for Disease Control and Prevention Storage Best Practices for Refrigerated Vaccines - Fahrenheit (F), “Don’t put vaccines on door shelves or on floor of refrigerator.” On 6/11/2025 at 0910, an unopened vial of heparin 30,000 units per 30 milliliter (mL) for injection was observed and the label affixed to the vial contained a handwritten expiration date of 7/1/25. Tech Staff confirmed the finding at the time of discovery that an unopened vial of heparin had a label with an expiration date of 7/1/25. On 6/11/2025 at 0914, an opened heparin vial containing 30,000 units in 30 mL for injection was observed on the counter in the patient care area and the label affixed to the vial contained an handwritten expiration date of 7/11. Nurse Staff G was immediately queried what expiration date do they apply to a heparin vial for injection after it was opened and punctured and they said, “30 days.” On 6/11/2025 at 1020, an opened heparin vial containing 30,000 units in 30 mL for injection was observed on the counter and a label affixed to the vial had a handwritten expiration date of 7/14/24. Nurse Staff G was immediately queried about the expiration date and they acknowledged placing the incorrect expiration date on the heparin vial. According to the facility’s policy “Multi-Dose Vials and Single-Dose Containers,” dated 12/15/2022, “Open MDVS are labeled with a BUD or discard date, not the date the vial is opened. Label the container with the BUD based on whichever of the following results in the shortest dating: 1. 28 days from the date that vial is opened, 2. The manufacturer; expiration date, 3. The bud determined after reconstitution.” On 6/12/2025 at 1545, Medical Director Staff B was queried if they expected staff to follow the facility’s policy and procedures, and they said “yes.””

“GOV-SERVICES FURNISHED ON THE MAIN PREMISES CFR(s): 494.180(d) The governing body is responsible for ensuring that the dialysis facility furnishes services directly on its main premises or on other premises that are contiguous with the main premises and are under the direction of the same professional staff and governing body as the main premises (except for services provided under §494.100). This Standard is not met as evidenced by: 36887 Based on interview and record review, Facility A failed to provide home dialysis services on or next to the premises and provide professional home dialysis staff under the govening body of the main premises resulting in the potential for unrecognized, unmet patient needs and poor patient outcomes for 1 of 1 home peritoneal dialysis patients currently served by the facility. Findings include: On 6/12/2025 at 0900, Staff A stated the medical record for the home peritoneal dialysis (PD) patient (P-5) was “en route” from Facility B. When queried as to why the medical record was not on the premises, she stated PD was contracted through Facility B and they were part of a “joint venture.” She further stated P-5 came to Facility A for clinic, but sent his treatment sheets to Facility B and went to Facility B for his lab work because that was where the nurse was based. On 6/13/2025 at 1036, P-5 stated during interview that he had done training, sent his treatment sheets, went for labs, and for questions and/or emergencies would call Faclity B. He further stated he lived closer to Facility A and did not know why they always sent him to Facility B (which was approximately 27 miles or 45 minutes away). On 6/13/2025 at 1045, review of the affiliation agreement revealed the agreement was between two hospitals (Facility C and Facility D), and lists “dialysis service management” but was not specific as to if it were for inpatient services, outpatient services, or both. For home dialysis, the estimated budget/cost was transferred to Facility C, not Faclity A. Mileage reimbursement was stated between Facility B to Facility A. This was the only reference present that is made regarding Facility A. The agreement did not address where services would take place.”