Saint Marys Hospital Dialysis Unit

“POC-MANAGE MINERAL METABOLISM CFR(s): 494.90(a)(3) Provide the necessary care to manage mineral metabolism and prevent or treat renal bone disease. This Standard is not met as evidenced by: 29151 Based on record review, policy review and interview, it was determined, the facility staff failed to provide necessary care and services to promote bone and mineral metabolism. The failure affected Patient #1. The findings included: Clinical record review conducted on 01/08/26 revealed Patient #1 was admitted to the facility on 07/15/25 for hemodialysis treatments and was prescribed Zemplar 7.5 micrograms on Mondays and Fridays. The record indicates on 12/12/25, Patient #1 was made inactive and was instructed to continue dialysis treatment on the acute setting, utilizing emergency department visits. The record indicates Patient #1 did not continue the bone mineral regimen, the Zemplar was not administered from 12/15/25 through 12/22/25 despite the patient receiving dialysis treatments in the emergency department. Electronic physician orders dated 12/29/25, 12/31/25 and 01/02/26 documents Zemplar 7.5 micrograms one time dose. There is no evidence the staff administered the prescribed medication. There are no current laboratory studies for calcium and parathyroid levels to indicate a clinical rationale to hold the medication. In addition, the medication order was renewed on 01/05/26 to be given every Monday, Wednesday and Friday, and there is no evidence it was administered on 01/05/26 during dialysis treatment. Interview conducted with the Nurse Manager on 01/08/26 at approximately 10:47 AM revealed the medication administration record provides no evidence that the Zemplar medication was administered as ordered. Interview with the Outpatient Dialysis Manager conducted on 01/08/26 at 10:50 AM explained she manages the outpatient dialysis team. The manager reviewed the documentation for Patient #1 and confirmed the outpatient dialysis nurse did not document the medications were given. Based on record review and staff interview, it was determined, the dialysis facility staff failed to implement bone mineral protocol and failed to administer the Zemplar, a synthetic form of vitamin D. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body. Zemplar is used to treat or prevent overactive parathyroid gland (hyperparathyroidism) in people with chronic kidney disease who are on dialysis. The facility failed to manage bone mineral therapy for Patient #1, who has not discharged from the chronic dialysis unit and was instructed to receive dialysis care in the acute setting due to funding. Facility policy titled “Medication Administration, last revised on 05/2025 documents the following: PURPOSE: To ensure an effective and safe medication administration system involving multiple services and disciplines. SCOPE: All areas where medications are administered and all staff who administer medications. POLICY: A medication shall be administered to a patient only when ordered by practitioners with appropriate privileges as set forth by the Medical Staff Bylaws. Prescriptions or medication orders are verified, checked for completeness and patients are identified utilizing 2 patient identifiers before medications are administered. Refer to the Patient Identification Policy for actual identification process. PROCEDURE: General principles of medication administration. The eight rights will be followed: Right patient Right dose Right medication Right time/frequency Right route Right patient education Right documentation Right to refuse In addition to licensed physicians and Allied Health Care Professionals with clinical privileges, the following personnel are authorized to administer medications as indicated upon receipt of a valid order. 1. Nursing Registered Nurses and Licensed Practical Nurses will administer medications as defined in their scope of practice. 2. Respiratory Therapy Certified Respiratory Therapy Technicians/Registered Respiratory Therapist will administer Aerosolized Pharmacologic agents that are commonly prescribed and used in the treatment of patients with pulmonary pathophysiology. 3. Imaging Preparation of oral/lV contrast material for imaging procedures and nuclear isotopes for scanning procedures are permitted to be carried out by a qualified Radiology Technologist when the Radiologist is present in the area. 4. Physical Therapy Physical Therapists may apply creams, ointments, or lotions as prescribed. C. Refer to Student Affiliation and Clinical Students policy regarding student nurses 1. Students will not be allowed to give any IV push medications. RN students may irrigate lines with saline. 2. Only hospital employees/approved contracted staff will have access to automated dispensing cabinet. D. The order is communicated in EHR, received and verified in the Pharmacy and reviewed by the nurse or respiratory therapist on the eMAR. Chemotherapy orders will continue to be hand written. The patient’s armband will be scanned. The medication, including chemotherapy will be scanned. Pre-administration parameters will be documented if appropriate. Allergies will be verified. Medication will be administered. High alert medications requiring co-signatures will be documented on the eMAR. Final documentation, including post-administration assessment will be documented on the eMAR.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 29151 Based on clinical record review and interview, it was determined, the facility failed to ensure a Hemodialysis patient received the medications prescribed for anemia management. The failure affected Patient #1. The findings included: Clinical record review conducted on 01/08/26 revealed Patient #1 was admitted to the facility on 07/15/25 for hemodialysis treatments and was prescribed Epogen 6000 units every Monday and Friday. The clinical record indicates on 12/12/25, Patient #1 was made inactive and was instructed to continue dialysis treatment in the acute setting, utilizing emergency department visits. Physician order dated 12/01/25 documents Epogen 6000 units every Monday and Friday with stop date of 01/01/2026. There is no evidence that the staff continued the anemia management and administered the prescribed medication on 12/15/25, 12/19/25, 12/22/25, 12/29/25 and 12/31/25. In addition, the medication order was renewed on 01/05/26 and there is no evidence it was administered a that time. Interview conducted with the Nurse Manager on 01/08/26 at approximately 10:47 AM revealed after review of the electronic medication administration record, there is no evidence that the prescribed Epogen was administered as ordered. Interview with the Outpatient Dialysis Manager conducted on 01/08/26 at 10:50 AM explained she manages the outpatient dialysis team. The manager reviewed documentation for Patient #1 and confirmed outpatient dialysis nurse did not document the medication was given. Based on record review and staff interview, it was determined, the dialysis facility staff failed to implement anemia protocol and failed to administer the Epogen, an Erythropoiesis Stimulating Agent (ESA) used to manage anemia for Patient #1, who was not discharged from the chronic dialysis unit and was instructed to receive dialysis care in the acute setting due to funding.”

“MD RESP-ENSURE IVD P&P FOLLOWED CFR(s): 494.150(c)(2)(ii) The medical director must- (2) Ensure that- (ii) The interdisciplinary team adheres to the discharge and transfer policies and procedures specified in §494.180(f). This Standard is not met as evidenced by: 29151 Based on record review and interview, it was determined, the facility failed to obtain a physician’s order to initiate and implement an involuntary discharge. The failure affected Patient #1 who experienced lack of funding. The findings included: Facility policy titled “Chronic Dialysis Routine and Involuntary Discharge and Transfer Process” last reviewed on 09/2025 documents as follows: PURPOSE: To provide a process for transferring patients who voluntarily request to receive their treatment at another dialysis unit or whom request discharge from Schwartz Dialysis and to outline guidelines for involuntary discharge. Facility obtains a written physician’s order that must be signed by both the Medical Director and the patient’s Attending Nephrologist concurring with the patient’s discharge or transfer from the facility. Clinical record review conducted on 01/08/26 revealed Patient #1 was admitted to the facility on 07/15/25 for hemodialysis treatments. The record validates that on 12/12/25, Patient #1 was made inactive and was instructed to continue dialysis treatments on the acute setting, through emergency department visits. The record failed to provide evidence of a physician order to discharge or transfer the patient from the dialysis unit to the outpatient acute setting. Interview with the Social Worker conducted on 01/08/26 at 10 AM revealed Patient #1 had billing issues dating back to September 2025, the patient’s mother changed insurance carriers and now required pre authorization for treatments, the mother was instructed to follow up with the primary care provider so the referral and authorization be obtained, the mother did not follow through. Then on 12/11/25 the nurse manager received a message from the finance office, instructing not to treat the patient anymore, to send her to the emergency department. The Social Worker stated she did not feel comfortable with the instructions and reached out to the Network for assistance. Patient #1 was made inactive as of 12/12/25. Interview with Nurse Manager conducted on 01/08/26 at 10:20 AM confirmed he received a text from the director instructing them to discharge the patient and sent her to the emergency room for future dialysis treatments. The Manager accessed the electronic record and confirmed the patient was made inactive as of 12/12/25 and there are no further orders or treatments since then. Interview with the Director of Rehabilitation and Dialysis Services conducted on 01/08/26 at 10:37 AM revealed the financial department advised her to refer the patient to the emergency department for further treatments due to insurance issues and lack of funding. The hospital leadership determined that was the best way to ensure the patient still received her treatments. The Director confirmed the required 30-day notice was not carried out prior to instructing the patient’s mother to utilize the emergency department for further treatments. Interview with the Medical Director for Pediatric Dialysis Services conducted on 01/08/26 at 11:17 AM, revealed he did not write a discharge or transfer order for Patient #1, he was told the patient had to transition to the acute setting due to funding issues and that was the only option to continue her care so he agreed and is not aware if a 30 day notice has been given.”

“GOV-INVOL DISCHARGE PROCESS REQUIREMENTS CFR(s): 494.180(f)(4) The medical director ensures that no patient is discharged or transferred from the facility unless - (4) The facility has reassessed the patient and determined that the patient’s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient’s interdisciplinary team- (i) Documents the reassessments, ongoing problems(s), and efforts made to resolve the problem(s), and enters this documentation into the patient’s medical record; (ii) Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge; (iii) Obtains a written physician’s order that must be signed by both the medical director and the patient’s attending physician concurring with the patient’s discharge or transfer from the facility; (iv) Contacts another facility, attempts to place the patient there, and documents that effort; and (v) Notifies the State survey agency of the involuntary transfer or discharge. (5) In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure. This Standard is not met as evidenced by: 29151 Based on policy review, record review and interview, it was determined, the facility failed to meet the requirements to initiate and implement an involuntary discharge. The failure affected Patient #1 who experienced lack of funding. The findings included: Clinical record review conducted on 01/08/26 revealed Patient #1 was admitted to the facility on 07/15/25 for hemodialysis treatments. The record validates that on 12/12/25, Patient #1 was made inactive and was instructed to continue dialysis treatment in the acute setting, through emergency department visits. The record failed to provide evidence of a physician order to discharge the patient from the dialysis unit to the outpatient acute setting. The record failed to provide evidence of an informed 30-day notice for involuntary discharge due to non payment. Interview with the Social Worker conducted on 01/08/26 at 10 AM revealed Patient #1 had billing issues dating back to September 2025, the patient’s mother changed insurance carriers and now required pre authorization for treatments, the mother was instructed to follow up with the primary care provider so the referral and authorization be obtained, the mother did not follow through. Then on 12/11/25 the nurse manager received a message from the finance team not to treat the patient anymore, to send her to the emergency department. The Social Worker stated she did not feel comfortable with the instructions and reached out to the Network for assistance. Patient #1 was made inactive as of 12/12/25. Interview with Nurse Manager conducted on 01/08/26 at 10:20 AM confirmed he received a text from the director instructing them to discharge the patient and send her to the emergency room for future dialysis treatments. The Manager accessed the electronic record and confirmed the patient was made inactive as of 12/12/25 and there are no further orders or treatments since then. Interview with the Director of Rehabilitation and Dialysis Services conducted on 01/08/26 at 10:37 AM revealed the financial department advised her to refer the patient to the emergency department for further treatments due to insurance issues and lack of funding. The hospital leadership determined that was the best way to ensure the patient still received dialysis treatments and confirmed the required 30-day notice was not carried out prior to the patient’s inactivation and instructions to obtain future dialysis treatments through the emergency department. Interview with the Medical Director for Pediatric Dialysis Services conducted on 01/08/26 at 11:17 AM, revealed he did not write a discharge or transfer order for Patient #1, he was told the patient had to transition the acute setting due to funding issues and that was the only option to continue her care, so he agreed and is not aware if a 30 day notice has been given. Facility policy titled “Chronic Dialysis Routine and Involuntary Discharge and Transfer Process” last reviewed on 09/2025 documents as follows: PURPOSE: To provide a process for transferring patients who voluntarily request to receive their treatment at another dialysis unit or whom request discharge from Schwartz Dialysis and to outline guidelines for involuntary discharge. SCOPE: Schwartz Dialysis Patients (Adult and Pediatric In-Center Hemodialysis and Home Peritoneal Dialysis), Schwartz Dialysis Staff, Dialysis Administrative Director and Nurse Manager, Schwartz Dialysis Medical Director, Schwartz Dialysis Nephrologists. POLICY: Chronic dialysis facilities must have an established process for patient voluntary transfer to another dialysis unit, voluntary discharge and involuntary discharge from the dialysis facility. The process must follow the Centers for Medicare & Medicaid Services (CMS) Conditions of Coverage. PROCEDURE All patients upon admission to Schwartz Dialysis will be informed of the facility’s policy for transfer, routine or involuntary discharge and discontinuation of services. INVOLUNTARY DISCHARGE OR TRANSFER Involuntary discharge (IVD) or transfer should be rare and preceded by demonstrated effort by the interdisciplinary team to address the problem in a mutually beneficial way. Before considering an IVD, the interdisciplinary team should: A. Conduct a thorough assessment of the situation and document in the medical record. B. Develop a plan to address any problems or barriers the patient may be experiencing. IVD should always be an option of last resort and should be initiated only after all options have been exhausted. Patients should not be discharged for failure to comply with facility policy unless the violation adversely affects clinic operations. Patients should not be discharged for shortened or missed treatments. Patients should not be discharged for failure to reach facility-set goals for clinical outcomes. Note: Patients who are non-compliant are at higher risk for morbidity and mortality. Discharging a patient for “non-compliance” is not an acceptable reason for discharge per the CMS Conditions for Coverage. An IVD can begin only if: A. All efforts to resolve the problem have failed. B. The issues and interventions to address them have been properly documented in the medical record. It is the Medical Director’s responsibility to ensure that no patient is discharged or transferred from the facility unless: A. The patient or payer no longer reimburses the facility for the ordered services a. There must be evidence in the patient’s medical record that the facility staff (e.g., billing personnel, financial counselor, social worker) made good faith efforts to help the patient resolve nonpayment issues B. The facility ceases to operate a. The governing body must notify CMS, AHCA and Florida ESRD Network 7 b. The dialysis interdisciplinary team must assist patients to obtain dialysis in other facilities C. The transfer is necessary for the patient’s welfare because the facility can no longer meet the patient’s documented medical needs a. The patient’s medical record must include documentation of the medical need and reasons why the facility can no longer meet that need. D. The facility has reassessed the patient and determined that the patient’s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case, the Medical Director ensures that the patient’s interdisciplinary team: a. Documents the reassessments, ongoing problem(s), and efforts made to resolve the problem(s), and enters this documentation into the patient’s medical record b. Provides the patient and the Florida ESRD Network 7 with a 30-day notice of the planned discharge c. Obtains a written physician’s order that must be signed by both the Medical Director and the patient’s Attending Nephrologist concurring with the patient’s discharge or transfer from the facility d. Contacts another facility, attempts to place the patient there, and documents that effort e. Notifies Agency for Health Care Administration (AHCA) of the involuntary transfer or discharge f. In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure Involuntary Discharge Steps to Complete: A. Inform the Attending Nephrologist and Medical Director of the patient considered for IVD and obtain approval. The Medical Director must ensure that the reasons for any involuntary discharge or transfer are consistent with the CMS Conditions for Coverage. B. Notify the Florida ESRD Network 7 of the potential IVD as soon as possible. c. Complete a comprehensive reassessment and revision of the plan of care for the patient considered for potential IVD as these patients would be considered unstable. The interdisciplinary team must reassess the patient with the intent to identify any potential action or plan that could prevent the need to discharge or transfer the patient involuntarily. If the reason for IVD is due to disruptive or abusive behavior the reassessment must focus on identifying the root causes of the behavior and result in a plan of care aimed at addressing those causes and resolving unacceptable behavior. D. Document in the patient’s medical record regarding the ongoing problem and facility efforts to resolve, e.g., patient/staff meetings, schedule change(s), community resource and/or mental health referrals, behavioral contracts/updates. E. Document any impact of behavior on other patient’s and staffs ability to safely provide care. F. Document patient response to each step taken and the interdisciplinary team’s reassessment of the situation. G. If unable to resolve the problem and IVD is planned, obtain a written physician’s order indicating agreement with the discharge and signed by both the Medical Director and the patient’s Attending Nephrologist (unless the Medical Director is the Attending). H. Provide the patient (and if applicable, legal guardian, skilled nursing facility., etc.) with a 30-day notice of discharge. l. Document all attempts to place the patient at another dialysis facility. The goal of contacting another dialysis facility is for continuity of care; the HIPAA privacy rule does not require patient consent to contact that other facility. However, it does limit sharing of protected health information to medical records requested by the other provider and prohibits sharing information obtained through hearsay. Good faith efforts should be made to find the closest facility to the patient’s residence that will accept the patient in transfer. J. Send the Florida ESRD Network 7 related interdisciplinary team assessments, contracts, documentation of facility efforts to the avert discharge or place the patient in another facility, letters of notification of discharge and any other written communication with the patient via fax to 813-354-1514 within 2 business days of completing the discharge K. Send the Agency for Health Care Administration (AHCA) related interdisciplinary team assessments, contracts, documentation of facility efforts to avert discharge or place the patient in another facility, letters of notification of discharge and any other written communications with the patient via fax to 850-414-6946 within 2 business days of completing the discharge. L. Report the patient as an IVD in CROWNWeb M. Complete the Florida ESRD Network’s IVD Checklist that outlines the steps listed above. Initial and date each area when the task has been completed. Return the checklist to the Network within 2 business days of an IVD being completed. Fax to 813-354-1514.”