Davita Tallahassee Dialysis

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 45827 Based on observations, facility policy review and interview, the facility failed to ensure 1 of 5 staff members observed removed gloves and performed hand hygiene. (Staff A) The findings include: On 12/03/2024 beginning at approximately 9:47 AM, Staff Member A, a Patient Care Technician, was observed disconnecting the patient from dialysis at Station #24. During the process, Staff A doffed (removed) gloves then donned (put on) new gloves on two separate occasions without using hand sanitizer. Staff Member A then walked from Station #24 to the supply cart, obtained additional supplies needed for the disconnection process and took them to Station #24 while wearing gloves doffed during the disconnection process. On 12/03/2024 at approximately 11:39 AM, Staff Member A was observed disinfecting Station #25. During the process, Staff Member A walked to Station #23 and touched the machine then walked to Station #26 and touched the machine, then returned to Station #25 without changing gloves. On 12/05/2024 a review of the facility’s policy and procedure 1-05-01, Infection Control for Dialysis Facilities revealed on Page 1, #1. All teammates, Physicians and Non-Physicians will perform hand hygiene (b) prior to gloving and immediately after removal of gloves, (d) after patient and dialysis delivery system contact, (f) between patients even if the contact is casual, (g) before touching clean areas such as supplies, supply cart and chairside keyboard/mouse. Page 2, #7. (a) Gloves should be changed when (iv.) After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system. On 12/05/2024 at approximately 10:37 AM an interview was conducted with the Facility Administrator who confirmed hand hygiene should be performed between glove changes and between patients.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 45827 Based on observations, facility policy review and interviews the facility failed to ensure staff disinfected scissors after patient contact for 1 of 5 staff members observed (Staff Member B) and failed to disinfect an oxygen concentrator stored at patient station for 1 of 5 staff members observed (Staff Member D). The findings include: On 12/02/2024 at approximately 10:30 AM, Staff Member B, a Patient Care Technician, was observed using scissors to remove the old dressing from a patient’s Central Venous Catheter (CVC) (a thin, flexible tube that is inserted into a vein, usually below the right collarbone, and guided into a large vein above the right side of the heart) at Station #10. Staff Member B did not clean the scissors before returning them to the supply cart. On 12/02/2024 at approximately 12:20 PM, Staff Member B was observed to bring scissors from supply cart to Station #11 and use them to remove the old dressing from the patient’s CVC. The scissors were then placed on the rolling computer cart between Station #10 and Station #11 without being cleaned. On 12/03/2024 at approximately 10:25 AM, Staff Member D, a Patient Care Technician, was observed disinfecting Station #14. Staff Member D did not clean the oxygen concentrator stored near the patient’s chair (approximately 18 inches) at Station #14. On 12/05/2024 a review of the facility’s policy and procedure 1-05-01, Infection Control for Dialysis Facilities, revealed on Page 3, #12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/designated area or removal from treatment area. Page 4, #14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. On 12/02/2024 at approximately 4:00 PM an interview was conducted with Staff Member B who stated the scissors should have been cleaned with bleach before returning them to the supply cart and should have been cleaned after using on one patient before being used on the next patient. On 12/03/2024 at approximately 10:50 AM an interview was conducted with Staff Member D who stated she does not clean the oxygen concentrator located near the patient’s chair unless the patient uses the machine. Staff Member D further stated the oxygen concentrator is always located close to the patient’s chair.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 45827 Based on observation, facility policy review and interview the facility failed to ensure staff removed Personal Protective Equipment (PPE) (disposable gown) when exiting the isolation room for 1 of 5 staff members observed. (Staff Member A) The findings include: On 12/03/2024 at approximately 9:34 AM, Staff Member A, a Patient Care Technician, was observed to leave pod F on the treatment floor and enter the isolation room where a patient was being dialyzed and make an adjustment to the dialysis machine. Staff Member A then exited the isolation room wearing the same gown, walked into the water room and then returned to pod F on the treatment floor. On 12/05/2024 a review of the facility’s policy Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance, 1-05-02 was completed. Page 6, #17, c. PPE will be removed, gloves discarded, and hand hygiene performed immediately when leaving the room or area. On 12/05/2024 at approximately 10:37 AM an interview was conducted with the Facility Administrator (FA) who stated staff gowns for the isolation room should be changed. The FA further stated there are hooks in the isolation room to hang the gowns on.”

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) 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- (1) At least annually for stable patients; This Standard is not met as evidenced by: 51235 Based on patient medical record review, interview, and review of the facility’s policy and procedure, the facility failed to ensure that a revision of the patient’s plan of care was conducted at least annually for 1 of 10 patient record reviews. (Patient #8) The findings include: On 12/05/2024 a medical record review was conducted for patient #8. Patient #8 was identified as ‘stable’ on last plan of care dated 01/24/2023. Review of the record failed to identify any other plan of care. An interview with the Facility Administrator (FA) on 12/05/2024 at approximately 11:15 AM indicated there has not been another assessment or plan of care conducted for patient #8. The FA indicated that patients that were considered ‘stable’ should have assessments and a plan of care completed annually. A review of the facility’s policy and procedure titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care”, Policy: 1-14-01, indicates “2. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs. The comprehensive assessment will be used to develop the patient’s treatment plan and expectations for care.” “7. A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted at least annually for stable patients and at least monthly for unstable patients including, but not limited to patients with the following: extended or frequent hospitalizations; marked deterioration in health status; significant changes in psychosocial needs; concurrent poor nutritional status, unmanaged anemia and inadequate dialysis.” “12. Subsequent interdisciplinary re-assessments should be completed within the 30 days following the initiation of the re-assessment. The Plan of Care following re-assessments must be completed within 15 days of completing the re-assessment. This process would occur monthly for unstable patients and annually for stable patients.””

“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: 51235 Based on interview, patient medical record review and review of the facility’s policy and procedure, the facility failed to ensure that monthly assessments were conducted by the Interdisciplinary Team for patients identified as unstable for 1 of 10 patient records reviewed. (Patient #1) The findings include: On 12/03/2024 a medical record review was conducted for Patient #1. Patient #1 was identified as ‘unstable’ by the facility. The facility conducted a Interdisciplinary plan of care on 8/13/2024 which was completed and signed by each discipline and signed by the patient. Review of the medical record failed to identify any other plan of care. An interview with the Facility Administrator (FA) on 12/05/2024 at approximately 11:00 AM indicated there has not been another assessment or plan of care conducted for the patient #1. The FA indicated that patients that were considered ‘unstable’ should have assessments and a plan of care completed monthly. A review of the facility’s policy and procedure titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care”, Policy: 1-14-01, indicates “2. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs. The comprehensive assessment will be used to develop the patient’s treatment plan and expectations for care.” “7. A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted at least annually for stable patients and at least monthly for unstable patients including, but not limited to patients with the following: extended or frequent hospitalizations; marked deterioration in health status; significant changes in psychosocial needs; concurrent poor nutritional status, unmanaged anemia and inadequate dialysis.” “12. Subsequent interdisciplinary re-assessments should be completed within the 30 days following the initiation of the re-assessment. The Plan of Care following re-assessments must be completed within 15 days of completing the re-assessment. This process would occur monthly for unstable patients and annually for stable patients.””

“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: 45827 Based on observations, medical record reviews, interviews and review of the facilitys policy and procedure, the facility failed to provide the correct dialyzer (a filter placed on the dialysis machine used to remove waste products and excess fluid from the patient’s blood) and the correct dialysis flow rate (DFR) (the rate at which the cleansing fluid, or dialysate, flows through the dialyzer) per physician’s prescription for 2 of 4 prescription verifications. (Patients #11 and #12) The findings include: On 12/03/2024 at approximately 11:30 AM a prescription verification was completed on patient #11 with Staff Member A, a Patient Care Technician. The prescription displayed on the computer listed an order for an Optiflux F180 dialyzer and a DFR of 700 milliliters (mL)/minute. The patient was being dialyzed with an Optiflux F160 dialyzer and a DFR of 600 mL/minute. Staff A corrected the DFR when pointed out during this observation. On 12/03/2024 at approximately 11:37 AM a prescription verification was completed on patient #12 with Staff Member A. The prescription displayed on the computer listed an order for an Optiflux F160 dialyzer and a DFR of 700 mL/minute. The patient was being dialyzed with an Optiflux F180 dialyzer and a DFR of 600 mL/minute. Staff A corrected the DFR when pointed out during this observation. On 12/05/2024 a review of the physician orders for Patient #11 revealed an order for an Optiflux F180 and a DFR of 600 mL/min. On 12/05/2024 a review of the physician orders for Patient #12 revealed an order for an Optiflux F160 and a DFR of 700 mL/min. On 12/05/2024 a review of the facility’s olicy and procedure, Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, Policy 1-03-08, revision date April 2024, revealed on Page 2, #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 with on one hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: (a) Dialyzer make and model, (g) Dialysate flow rate. On 12/03/2024 at approximately 11:30 AM an interview was conducted with Staff Member A who stated he did not double check the dialyzer for Patient #11 to see that is was the wrong one. Staff Member A further stated patient #11 and patient #12 were sat in the wrong chairs to dialyze and was not sure who verifies the prescription. On 12/03/2024 at approximately 11:45 AM an interview was conducted with Staff Member E, a Registered Nurse. Staff Member E stated she completed the prescription verification for patient #11 already but has not verified the prescription for patient #12. She stated she was not aware that either patient #11 or patient #12 were dialyzing on the wrong dialyzer. Staff Member E further stated she did not know if a report needed to be filled out for patients not using the correct dialyzers and was not sure if the physician needed to be notified.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 51235 Based on patient medical record review, interview and facility policy review, the facility failed to ensure an initial plan of care was completed and implemented within 30 days or 13 hemodialysis sessions for 1 of 10 patient records reviewed. (Patient # 9) The findings include: A review of the medial records for patient # 9 showed an admission to facility on 09/09/2024. There was no initial plan of care completed and implemented within 30 days or 13 dialysis sessions. On 12/04/2024 at approximately 11:00 AM, the Senior Manager of Clinical Services confirmed that Patient #9 did not have a completed initial Plan of Care. A review of the facility’s policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care”, #1-14-01, under ASSESSMENT indicates “4. A comprehensive assessment will be conducted on all new patients within 30 calendar days ( or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.””

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 51235 Based on staff interview and review of the facility’s monthly Quality Assurance / Performance Improvement meeting minutes, the facility failed to ensure participation by all professional members of the Interdisciplinary Team, as evidenced by lack of attendance and participation of the Registered Dietitian at scheduled meetings. The findings include: A review was completed of the facility’s Quality Assurance/Performance Improvement meeting minutes for June 2024 through October 2024. The Interdisciplinary Team (IDT) meets every month. The attenance sheets for 3 meetings held in August through October lacked participation or signature of attendance for the Registered Dietitian. A review of the facility’s policy titled; “Continuous Quality Improvement Program”, Policy #1-14-06, indicates “1. Each dialysis facility will have a Continuous Quality Improvement (CQI) Committee comprised of at least the following individuals from the interdisciplinary team: Facility Medical Director, Facility Administrator (FA)/designee, Registered Nurse, Biomed Technician, Registered Dietitian, and Social Worker.” An interview was conducted with the Facility Administrator, and Senior Clinical Services Manager on 12/5/2024 at approximately 11:45 AM confirmed the previous dietitian had resigned and the QAPI meetings conducted in August, September and October were not attended by a dietitian.”