Initial Comments:
Based on the findings of an onsite unannounced recertification survey completed on 2/6/2026, Dialysis Clinic Inc. was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services - Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed 2/6/2026, Dialysis Clinic Inc. was found to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.80(a)(2) STANDARD
PA-APPROPRIATENESS OF DIALYSIS RX
Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:
(2) Evaluation of the appropriateness of the dialysis prescription,
Observations:
Based on a review of facility policies and procedures, medical records (MR) and staff (EMP) interviews, the facility failed to ensure the evaluation of the appropriateness of the dialysis prescription including blood flow rate (BFR) and dialysate flow rate (DFR) to communicate with physicians when adjustment was beyond the current physicians' orders for two (2) of four (4) in-center hemodialysis medical records (MR) reviewed (MR3 and MR4).
Findings included:
A review was conducted of facility policy on 2/6/2026 at approximately 11:00 AM which revealed, " ADMINISTRATION OF MEDICATIONS POLICY: Registered Nurses shall give medications that have been ordered by the Nephrologist ... "
MR #3 admit date 10/21/2015, was reviewed on 2/5/2026, at approximately 2:15 PM. A review of the treatment plan order dated 6/2/2025 and treatment sheets dated 1/13/2026 through 1/29/2026 revealed the physician ordered a DFR of 600 ml/min. DFR was delivered lower than prescribed on 1/19/2026 at 350 ml/min for the entire treatment. Documentation was completed on the treatment sheet of 1/19/2026 by three staff members.
MR #4 admit date 10/21/2015, was reviewed on 2/2/2026, at approximately 3:15 PM. A review of the treatment plan order dated 1/28/2026 and treatment sheets dated 1/12/2026 through 1/30/2026 revealed the physician ordered a BFR of 400 ml/min. BFR was delivered lower than prescribed on 1/28/2026 at 340 ml/min for the entire treatment. Documentation was completed on the treatment sheet of 1/28/2026 by three staff members.
No documentation was available to confirm standing order that allowed for adjustment of the patient's BFR and DFR.
An exit interview was conducted with the administrator, manager and biomedical manager on 2/6/2026 at approximately 3:15 PM reviewing the survey findings.
Plan of Correction:1. All clinical staff will be re-trained on the facility's "Administration of Medications" policy by 2/27/26. Training will include the responsibility to evaluate ordered treatment parameters and ensure that patients are receiving their appropriate dialysis prescription. In addition, training will include the responsibility of documenting the reason when unable to achieve the prescribed BFR and/or DFR and notification to the Charge Nurse. The Charge Nurse will be responsible for notifying the physician if unable to achieve the prescribed BFR for three (3) consecutive treatments.
2. All clinical staff will review and sign acknowledgement of understanding of policy. Acknowledgement will be placed in the facility's education manual and/or personnel file.
3. Charge Nurse or designee will round and initial records to confirm treatment parameters are set per physician orders.
4. Initially, Nurse Manager and/or Designee will audit 25% of treatment flow sheets daily for one (1) week to ensure that staff is following the policy with emphasis on documentation of patient receiving their appropriate dialysis prescription. If standards are met, 25% of the treatment flow sheets will be audited weekly for four (4) weeks. If standards are met, 25% of the treatment flow sheets will be audited monthly for three (3) months. If standards are met, 25% of the treatment flow sheets will be audited semi-annually. The audit results will be reviewed at monthly QAPI meetings.
494.80(a)(3) STANDARD
PA-IMMUNIZATION/MEDICATION HISTORY
Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:
Immunization history, and medication history.
Observations:
Based on a review of agency policy, medical record (MR) and staff (EMP) interview, it was determined that the agency failed to maintain an accurate medication profile of all medications the patient was taking in order to identify and address potential adverse effects, drug reactions, ineffective drug therapy, significant side effects, drug interactions and noncompliance for two (2) of six (6) MR's reviewed (MR3 and MR6). The agency failed to correctly mark medication during one (1) of one (1) facility observation tour (OBV) completed.
Findings included:
A review was conducted of facility policy on 2/6/2026 at approximately 11:00 AM which revealed, " Use of Multiple dose Vials PURPOSE: To provide the hemodialysis clinic with guidance and recommendations for the safe and proper use of multiple-dose medication vials. SUPPORTIVE DATA: A multiple-dose (multi-dose) vial is a bottle of injectable liquid medication (or diluent) containing more than one dose of medication or (or diluent), and is approved by the Food and Drug Administration (FDA) for use on multiple persons ...POLICY ... 2. When a multi-dose vial has been opened (e.g., needle-punctured or vial cap removed), the vial should be dated, initialed and discarded within 28 days, unless the manufacture specifies a shorter date for that opened vial. Refer to package insert and/or manufacturer expiration date to determine the beyond-use-date ...11. If a vial is labeled as multi-dose, double check the expiration date and the beyond-use-date (if applicable) before using ... "
A review was conducted of facility policy on 2/26/2026 at approximately 11:00 AM which revealed, " Medication Reconciliation for Patient ' s Home Medication ...POLICY: All patients ' medication and medication allergy lists will be reconciled and updated in the patient ' s electronic medical record: 1. Within 3 treatments upon admission to dialysis clinic. 2. At least once per month. 3. Medications and allergy list will also be reconciled within 3 treatments upon discharge from hospital, skilled nursing facility, or rehabilitation facility to home. The Medication Reconciliation process involves 5 steps: Obtain a current medication and allergy list from the patient or their designee ...Compare newly obtained medication and allergy information to that which is already present in the medical record. Validate review discrepancies with the patient and/or associated health care provider ...Document medication reconciliation and validated changes to medication and allergy information in the medical record via Darwin Problem List ...Communicate medication order changes to the patient/caregiver and the patient ' s pharmacy (including new medications, stopped/discontinued medication, and/or new directions) and provide an updated list to patient ... "
MR #3 admit date 10/21/2015, was reviewed on 2/5/2026, at approximately 2:15 PM. The primary diagnosis was unspecified complication of kidney transplant. The agencies " HEMODIALYSIS TRANSFER FORM" listed under section "Allergies; ADHESIVE TAPE, AMLODIPINE BESYLATE, ATIVAN, BIAXIN, DIAMOX, ERYTHROMYCIN, HCA TRIPLE ANTIBIOTIC OINTMENT, LISINOPRIL, PENICILLINS ... " The surveyor reviewed the paper chart with a history and physical provided with a print date 9/22/2025. Listed under the Allergies, Adhesive bandage ...Biaxin ...Diamox ...Triple Antibiotic Ointment ...erythromycin ...penicillin ...varicella virus vaccine ... " The facility staff was notified that allergies listed on the documents did not match.
MR #6 admit date 8/24/2015, was reviewed on 2/5/2026, at approximately 3:00 PM. The primary diagnosis was focal glomerulosclerosis, focal sclerosing GN. The agencies " HEMODIALYSIS TRANSFER FORM" listed under section "Allergies; ADHESIVE TAPE, AF-IBUPROFEN, CELEXA, LISINOPRIL, PENICILLINS, SHELLFISH, TORADOL HCL, VICODIN HEMOTRANSFER ... " The surveyor reviewed the paper chart with a history and physical provided with a print date 5/22/2025. Listed under the section " Allergies, Adhesive Bandage ...CeleXA ...Colcrys ...Dairy ...Seafood ...Toradol ...ibuprofen ...penicillins ...shellfish ...traMADol ... " The facility staff was notified that allergies listed on the documents did not match.
During a facility observation tour (OBV1) on 1/30/2026 at approximately 10:29 AM at the location )of the medication room a vial of Doxercaiciferol injection 4 mcg per 2 ml (2 mcg per mL) Multi-Dose Vial For Intravenous use only Exp 2027-05 was on the counter, and no date or initials were located on the vial.
An exit interview was conducted with the administrator, manager and biomedical manager on 2/6/2026 at approximately 3:15 PM reviewing the survey findings.
Plan of Correction:1. All RN staff will be re-trained on the facility's "Use of Multiple Dose Vials" policy and "Medication Reconciliation for Patient's Home Medication" policy by 2/27/26. Training will include the responsibility for primary nurses to review all H & P/Medical documents received by the clinic to include the reconciliation of listed medications and/or allergies and to update the patient's electronic medical record.
2. All RN staff will review and sign acknowledgement of understanding of policies. A copy of the acknowledgement will be placed in the facility's education manual.
3. Primary nurses will conduct a review of all current electronic medical records to ensure that medications and allergies have been reconciled and are up to date in the medical records. During the monthly reconciliation of medications, primary nurses will complete a confirmation review of allergies as part of the reconciliation.
4. Initially, Nurse Manager and/or Designee will audit the medical record for 20% of our patients monthly until all patient records are completed to ensure that primary nursing staff are following the policy. If standards are met, the medical record for 20% of our patients will be audited quarterly for one year. The audit results will be reviewed at monthly QAPI meetings.
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