Davita Mt Dora Dialysis

“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: 49777 Based on observation, record review and interview the facility failed to follow the guidance and recommendations for the safe and proper use of multiple-dose medication vials when preparing heparin syringes for patient use. Findings include: On 7/29/24 at 12:00 PM, there were two heparin vials in the heparin medication preparation area. Both vials had heparin in them, but the vials did not have staff initials or expiration date on the vial. On 7/29/2024 at 12:01 PM, Staff A Registered Nurse (RN), was interviewed about the unlabeled vials and stated that the other RN had drawn up heparin and the vials would be discarded. On 7/29/24 at 12:05 PM, The Facility Administrator confirmed the two heparin vials did not have initials and expiration date on them. The Facility Administrator was observed going to the RN that drew up the vials to show her that the vials were not initialed and did not have expiration dates. Record review of the facility policy titled “Medication Policy,” review date of October 2023, showed the policy read “Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured), unless the manufacturer specifies a different (shorter or longer) date or as directed by manufacturer as in the case of vaccines or state specific pharmacy regulations. Each vial is labeled with the initials of the person opening the vial and the expiration date. Medications are stored in the original vial and are not drawn up and stored overnight in a syringe or any other container.””

“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: 15234 Based on record review and interview the facility failed to follow the prescribed blood flow rate (BFR) for 2 patients, Patient #6, Patient #9, and failed to follow the prescribed dialysate flow rate (DFR) for 2 patient, Patient #2 and Patient #6, of 10 in center hemodialysis patients reviewed. Findings Include: Review of Patient #2’s dialysis treatment record, dated 7/26/2024, revealed Patient #2 was prescribed a dialysate flow rate of 500. Record review of Patient #2’s dialysis treatment record revealed that Patient #2’s dialysate flow rate during dialysis treatment was set at 600 three times and set at 610 six times during her treatment on 7/26/2024. Record review of Patient #2’s dialysis treatment record failed to reveal documentation that justified or explained why Patient #2’s dialysate flow rate had deviated from her prescribed blood flow rate. Review of Patient #6’s dialysis treatment record, dated 7/24/2024, revealed Patient #6 was prescribed a blood flow rate of 300. Record review of Patient #6’s dialysis treatment record revealed that Patient #6’s blood flow rate during dialysis treatment was set at 350 seven times during her treatment on 7/24/2024. Record review of Patient #6’s dialysis treatment record failed to reveal documentation that justified or explained why Patient #6’s blood flow rate had deviated from his prescribed dialysate flow rate. Record review of Patient #6’s dialysis treatment record, dated 7/24/2024, revealed Patient #6 was prescribed a dialysate flow rate of 500. Record review of Patient #6’s dialysis treatment record revealed that Patient #6’s dialysate flow rate during dialysis treatment was set at 600 six times during her treatment on 7/24/2024. Record review of Patient #6’s dialysis treatment record failed to reveal documentation that justified or explained why Patient #6’s dialysate flow rate had deviated from her prescribed dialysate flow rate. Review of Patient #6’s dialysis treatment record, dated 7/26/2024, revealed Patient #6 was prescribed a blood flow rate of 300. Record review of Patient #6’s dialysis treatment record revealed that Patient #6’s blood flow rate during dialysis treatment was set at 350 eight times during her treatment on 7/26/2024. Record review of Patient #6’s dialysis treatment record failed to reveal documentation that justified or explained why Patient #6’s blood flow rate had deviated from his prescribed dialysate flow rate. Record review of Patient #6’s dialysis treatment record, dated 7/26/2024, revealed Patient #6 was prescribed a dialysate flow rate of 500. Record review of Patient #6’s dialysis treatment record revealed that Patient #6’s dialysate flow rate during dialysis treatment was set at 600 eight times during her treatment on 7/26/2024. Record review of Patient #6’s dialysis treatment record failed to reveal documentation that justified or explained why Patient #6’s dialysate flow rate had deviated from her prescribed dialysate flow rate. Review of Patient #9’s dialysis treatment record, dated 7/22/2024, revealed Patient #9 was prescribed a blood flow rate of 350. Record review of Patient #9’s dialysis treatment record revealed that Patient #9’s blood flow rate during dialysis treatment was set at 300 six times during his treatment on 7/22/2024. Record review of Patient #9’s dialysis treatment record failed to reveal documentation that justified or explained why Patient #9’s blood flow rate had deviated from his prescribed dialysate flow rate. During an interview on 7/31/2024 beginning at 12:25 PM, the Facility Administrator acknowledged physician’s orders related to blood flow rate and dialysate flow rate had not been followed consistently and that staff had not documented the reason for any deviation from the prescriptions. Review of the facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, revised April 2021, showed the policy read “2. The Nursing assessment will be performed and documented by a licensed nurse; specifically a Registered Nurse (RN) or if performance of a nursing assessment is permitted by state law, a Licensed Practical Nurse (LPN) / Licensed Vocational Nurse (LVN). a. The assessment includes the following components: i. Review of patient reports, data collection, complaints and response to treatment ii. Verification that machine safety checks have been completed and documented iii. Verification of prescription including machine parameters.” The policy specified “3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law.” and “4. Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to the “Abnormal Findings” section of this policy.) If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis.””

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 49777 Based on observation, record review and interview the facility failed to ensure that the physician conducted in-center visits for one dialysis Patient, #9 of 10 sampled patients at least quarterly at the dialysis center during dialysis treatment to assess the patient’s response to treatment and to observe the team care. Findings include: Review of the in-office nephrologist physician assessments for Patient #9, dated February 20, 2024, March 29, 2024, April 2, 2024, May 7, 2024, June 6, 2024, and July 16, 2024 showed Patient #9 did not have documentation for quarterly in -center visits for two quarters for the period of January 2024 through July 2024. There was no documentation for two consecutive quarters that an in-center dialysis facility visit was conducted by the patient’s nephrologist while the patient was receiving dialysis to assess the patient’s response to treatment and to observe care. During interview on 7/30/24 at 1:22 PM, the Medical Director stated that she was “not the nephrologist for all the patients receiving dialysis in-center but there was a medical staff bylaw expectation for the nephrologist to see their patients monthly and in-center while the patient is receiving treatment at least once every three months.” During interview on 7/30/2024 at 1:40 PM, the Facility Administrator stated “not all physicians come to see their patient while they are in-center receiving their treatment. When asked if there was physician documentation for Patient #9’s quarterly in-center visits where the nephrologist observed the patient while receiving a treatment, she stated she did not have quarterly in-center visits by the nephrologist of Patient #9. Record review of the facility Medical Staff Bylaws, published June 14, 2021, showed the bylaws read under 2.2.2 Rounding and Documentation Requirements: “a) Ensure patient are rounded on in compliance with [Corporation and Network Name] state and federal requirements. At minimum, this includes the following requirements ( unless state law or a Public Health Emergency dictates otherwise) for: i. In-center and/or nocturnal patients: must be evaluated and examined by nephrologist no leass than once per month in-person in the facility while the patient is on dialysis; a. In the rare event that a monthly evaluation and examination cannot reasonable be conducted at the Facility, an evaluation and examination may take place at the patient’s home, in the physician’s office, or at another location that complies with DaVita policies, so long as the record of care is promptly incorporated in the Facility medical record. ii. Home patients: must be evaluated and examined no less than once per month. At least once per quarter, this monthly evaluation must be conducted by a nephrologist in the Facility. The remaining two of the three required monthly visits per quarter may be fulfilled by an office visit, home visit, or telehealth visit (if convenient for the patient), or NPP visit, so long as the record of care is promptly incorporated in the Facility medical record.””