Davita Franklin Dialysis at Home

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 45377 Based on a review of medical records (MR), facility policy, and an interview with the administrator, the facility did not follow its policy regarding the performance of quarterly emergency/disaster preparedness drills for two (2) of five (5) MR reviewed: MR#2 and MR#4. Findings include: A review of the following policy was conducted on July 24, 2024 at 10:00 AM: Policy 5-01-21 Home Dialysis Monitoring and Ongoing Patient Education reads in part, “The following need to be reviewed at least quarterly: Emergency/disaster preparedness.” A review of MRs was conducted on July 22, 2024 starting at 12:30 PM and again on July 23, 2024 starting at 8:35 AM. MR#2 Admission Date (AD) 02/17/2022 did not contain any evidence of quarterly emergency disaster/preparedness drills conducted for quarters two (2) and four (4) in 2023, and quarters one (1) and two (2) in 2024. MR#4 AD 02/08/2022 did not contain any evidence of quarterly emergency disaster/preparedness drills conducted for quarters one (1) and two (2) in 2024. An interview conducted with the administrator, clinical nurse manager, medical director, regional home manager, regional operations director, and group facility administrator on July 24, 2024 at 1:00 PM confirmed the above findings.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 45377 Based on observations (OBS) of the Dialysis Home Training Unit, a review of facility policies, a review of infection control documents, and an interview with the administrator, the facility failed to remove expired supplies and medications from the above mentioned area for two (2) of two (2) observations: OBS#1 and OBS#2. Findings include: A review of the following facility policies took place on July 24, 2024 starting at approximately 10:15 AM: Policy 5-06-01 Infection Control For Dialysis Facilities reads in part, “Supplies will be stored in a manner that maintains their integrity.” Policy 5-07-01 Medication Policy reads in part, “Medications are ordered and replaced prior to expiration” and “All medications in the facility are checked monthly.” A review of infection Control Audits on July 23, 2024 at approximately 2:00 PM revealed that medication/supply audits completed February 2024, April 2024 and May 2024 found that no medications or supplies were expired. Observation #1 took place in the Dialysis Home Training Unit from 9:30 AM 11:30 AM on 07/22/2024. The observation revealed the following: Laboratory Area: Cabinet Above the Dirty Sink: A plastic bag containing eight (8) Specimen Transport Bags used for swab sample collection and storage found eight (8) expired lab tubes containing 3.0 ml (milliliters) 0.85% saline solution, expiration date 09/01/2023, lot# 211911, and eight (8) expired classiqswabs expired 09/30/2023, lot#196M39. A second plastic bag containing five (5) expired lab tubes containing 3.0 ml of 0.85% saline solution used for swab sample collection expired 01/2024, lot#221801 and five (5) classiqswabs expired 10/31/2023, lot#2025004. A third plastic bag containing five (5) Specimen Transport Bags used for swab sample collection and storage found five (5) expired lab tubes containing 3.0 ml of 0.85% saline solution expired 09/01/2023, lot@211911, and five (5) classiqswabs expired 09/30/2023, lot#2022105 Laboratory Area: Cabinet Above the Centrifuge Machine One (1) anaerobic BD Bactec Blood Culture bottle (purple top) expired 06/13/2024, lot#3249490, and one (1) aerobic BD Bactec Blood Culture bottle (blue top) expired 06/13/2024, lot#3249473. Medication Refrigerator Across From Training Room #4 The medication refrigerator contained a 10-box capacity of Hepatitis B Vaccine (Energix B) which expired 07/12/2024, lot#DZ747. Eight (8) vials were remaining in the box. Medication Refrigerator Across From Training Room #8 The medication refrigerator contained a 10-box capacity of Hepatitis B Vaccine (Energix B) which expired 07/12/2024, lot#3H3RX. Four (4) vials were remaining in the box. Observation #2 took place in the Dialysis Home Training Unit from 9:45 AM 10:00 AM on 07/23/2024. The observation revealed the following: Medication Preparation Area across from Training Room #8: A drawer containing two (2) 25 gauge (ga) needles expired on 09/30/23, lot#8204577, and two (2) 22 ga needles expired on 01/31/2023, lot#8290511, An interview conducted with the administrator, clinical nurse manager, medical director, regional home manager, regional operations director, and group facility administrator on July 24, 2024 at 1:00 PM confirmed the above findings.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 45377 Based on a review of medical records, facility policy, peritoneal dialysis (PD) treatment records/flowsheets, and an interview with the administrator and manager of clinical services, the facility failed to provide evidence of adequate home peritoneal dialysis (PD) monitoring for three (3) of three (3) PD patients: MR#2, MR#3, and MR#4. Findings include: A review of the following Peritoneal Dialysis Policies and Procedures occurred on July 22, 2024 starting at 2:00 PM: Facility Policy 5-01-21 Home Dialysis Monitoring and Ongoing Patient Education reads in part, “Retrieve paper home treatment records at least monthly, and review within seven (7) days of receipt, if required data has not been captured electronically.” Facility Policy 5-01-29 Daily Home Treatment Record (Flowsheet) states in part, “As clinically applicable, all treatment data outlined on the Daily Home Treatment Record must be collected. Completed Daily Home Treatment Records must be reviewed to assist in evaluating the patient’s progress and self-care decision-making process. This post-treatment data review will be verified by the Peritoneal Dialysis registered nurse documenting review in the medical record per guidance below: a) the licensed nurse will review the patient’s data via submitted Daily Home Treatment Records....d) the licensed nurse is responsible for end of month review for all Daily Home Treatment Records.” The policy also contains a section on Abnormal Findings which reads in part, “...the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record....Fluid Status: if patient is above or below 2 kg from the target weight and if patient is using 4.25% (red) dialysate; Blood Pressure: Systolic greater than 150mm/Hg or less than 90mm/Hg, Diastolic greater than or equal to 100mm Hg; Temperature Pre/Post/PRN: Greater than 100 degrees Fahrenheit or 2 degree rise over baseline;” and “All Daily Home Treatment Records will be reviewed, attested to, and maintained as part of the patient’s medical record. In the absence of Daily Home Treatment Records, the licensed nurse will review with the patient the importance of Daily Home Treatment Records, and the patient’s responsibility to provide them and issue new paper flowsheets....All of the above will be documented and attested to by the licensed nurse in the medical record. Based on what the patient submits, some follow-up may be necessary and the patient’s electronic health record must be updated to reflect any new information obtained.” An interview with the administrator was conducted on July 24, 2024 at approximately 10:00 AM. The administrator stated that peritoneal dialysis patients are required to bring their flowsheets into the clinic at least once per month, at which time the nurse will review the flowsheets. In an interview conducted with the administrator, clinical nurse manager, medical director, regional home manager, regional operations director, and group facility administrator on July 24, 2024 at 1:00 PM, the surveyor noted that of the three (3) PD medical records reviewed, all 3 patients were using different daily home treatment flowsheets which varied in the content to be recorded by the patient and/or caregiver. A review of MRs was conducted on July 22, 2024 starting at 12:30 PM and again on July 23, 2024 starting at 8:35 AM. The admission date (AD) is indicated below. MR#2 AD 02/01/2024. The PD prescription dated 02/19/2024 contained orders for a target weight of 60.0 kg (kilograms). The treatment schedule was seven (7) days per week via CCPD (continuous cycling peritoneal dialysis). A review of daily home treatment records from 05/01/2024 through 07/16/2024 found that the patient’s caregiver had created a Daily Home Continuous Cycler Peritoneal Dialysis Record/Flowsheet using Microsoft Excel. The flowsheet contained columns for collection of temperature (T), blood pressure (BP) and pulse (P) pre and post treatment, and the solution used, in addition to some other data. The flowsheet did not contain a column for patient weights (WGT). The flowsheets were reviewed by a nurse on 05/10/2024 and 06/11/2024. There was no documentation as to the reason for the absence of weights nor education to the patient and/or caregiver concerning the importance of collecting the patient’s weight. MR#3 AD 05/16/2024. The PD prescription dated 05/16/2024 contained orders for a target weight of 65.0 kg. The treatment schedule was 7 days per week via CCPD. A review of daily home treatment records from 05/16/2024 to 07/17/2024 found inconsistency in data collection throughout the above time frame. The form being used only contained one column for blood pressure measurement and the column did not denote if the BP was intended to be pre or post treatment. There were no treatments recorded for 5/20, 6/20, and 7/9. Treatment flowsheets were not provided for the time frame 6/30 to 7/5. No temperatures were recorded for the above time frame of 5/16 to 7/17. No weights, BP, or P were recorded on 5/17, 5/19, 5/21, 5/24, 6/6, 6/29, 7/2. No BP or P was recorded on 5/23, 5/28, 6/1, 6/3, 6/8, 6/10, 6/11, 6/13, 6/15, 6/17, 6/18, 6/21, 6/22, 6/26, 6/27, 7/6, 7/8, 7/13, 7/16, and 7/17. Only one BP was recorded on 5/18, 5/22, 5/25, 5/27, 5/29, 5/31, 6/2, 6/4, 6/5, 6/7, 6/9, 6/12, 6/14, 6/16, 6/19, 6/23, 6/24, 6/25, 6/28, 7/7, 7/10 and 7/15. A review of the medical record found that the nurse reviewed the submitted flowsheets on 05/31/2024 and 06/20/2024. A review of flowsheets after 6/20/2024 was pending a July 25th clinic visit. There was no documentation as to the reason for the above missing data, nor any documentation of education with the patient and/or caregiver about ongoing issues with collecting the required data. MR#4 AD 02/08/2022 The PD prescription dated 04/19/2024 contained orders for a target weight of 53.0 kg. The treatment schedule was 7 days per week via CCPD. A review of daily home treatment records from 05/19/2024 to 07/13/2024 found inconsistency in data collection throughout the above time frame. There were no treatments recorded for: 5/21, 5/23, 5/24, 5/26, 5/28, 5/30, 6/8, 6/15, 6/19, 6/22, 6/23, 6/27, 6/30, 7/1, 7/3, 7/5, and 7/7. From 05/19 to 07/13, there were no pre or post weights or temperatures recorded. The type of solution being used was not recorded. Missing data from the post therapy section included no BP or P recorded on 6/9, 6/17, 6/21, 6/24, 6/25, 6/28, 6/29, 7/2, 7/11, 7/12, and 7/13. A review of the medical record found that the nurse reviewed the submitted flowsheets on 06/18/24 and 7/17/2024. There was no documentation as to the reason for the above missing data, nor any documentation of education with the patient and/or caregiver about ongoing issues with collecting the required data. An interview conducted with the administrator, clinical nurse manager, medical director, regional home manager, regional operations director, and group facility administrator on July 24, 2024 at 1:00 PM confirmed the above findings.”

“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: 45377 Based on a review of medical records (MR), personnel files (PF), the Centers for Disease Control and Prevention (CDC) guidelines, facility policies, and an interview with the administrator, the facility failed to provide evidence of following its policies related to tuberculosis (TB) screening for one (1) of five (5) MR’s reviewed: MR#1, and three (3) of three (3) PF’s reviewed: PF#1, PF#2, and PF#3. Findings include: The following Home Hemodialysis (HHD) Policy was reviewed on July 23, 2024 at 2:00 PM: Policy 12-07-03 reads in part, “Patients with chronic kidney disease (CKD) are considered high risk for progression from latent TB infection (LTBI) to active TB disease and will be screened for TB prior to first treatment;” and TB surveillance will be performed on admission...” The policy contained a Table outlining the various scenarios that may be encountered for permanent admission new to dialysis which reads in part, “Documentation Available: Negative TST (1 step) Prior to 1st Treatment: NA Upon Admission: Administer a second TST one (1) to three (3) weeks after the pre-admission TST was obtained or as soon as possible following admission, if three (3) weeks or more have passed. Documentation Available: Positive TST or IGRA history Prior to 1st Treatment: CXR and documented medical follow-up Upon Admission: Complete TB-RAQ (Risk Assessment Questionnaire) Documentation Available: TST or IGRA (TB Blood Test) not available Prior to 1st Treatment: CXR (chest x-ray) Upon Admission: Administer one step TST followed by a second TST one (1) to three (3) weeks after the admission TST or draw QFTG (QuantiFERON-TB Gold)” A review of MRs was conducted on July 22, 2024 starting at 12:30 PM and again on July 23, 2024 starting at 8:35 AM. The admission date (AD) is indicated below. MR#1 AD 04/29/2024, HHD patient, contained documentation that prior to admission, a TST was administered on 03/04/2024 (found to be negative) and a chest xray was obtained on 04/04/2024. A second TST was not administered upon or after admission to the facility. The Centers for Disease Control and Prevention (CDC) and the National TB Controllers Association released updated recommendations for Tuberculosis (TB) screening, testing, and treatment of health care personnel on May 17, 2019. These recommendations update the health care personnel screening and testing section of the 2005 CDC Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Settings. All health care personnel should be screened for TB upon hire (i.e., preplacement). TB screening is a process that includes: a baseline individual TB risk assessment, a TB symptom evaluation, and a TB test (e.g., a TB single blood assay test or a two-step tuberculin skin test (TST), and additional evaluation for TB disease as needed. Health care personnel with a positive TB test result should receive a symptom evaluation and a chest x-ray to rule out TB disease. Additional workup may be needed based on those results. All health care personnel should receive TB education annually. TB education should include information on TB risk factors, the signs and symptoms of TB disease, and TB infection control policies and procedures. (CDC/MMWR/May 17, 2019/Vol.68/No.19). The following facility policy was reviewed on July 24, 2024 at 10:30 AM: Policy 4-06-05 Tuberculosis Monitoring and Follow-Up reads in part, “If exemption criteria for TST is not met, the following testing options are available: Baseline TST using a two step Purified Protein Derivative (PPD) Mantoux test (a second TST repeated one to three weeks after the first, if the initial test is negative. A second TST is not needed if the teammate can show documented TST results from any time during the previous 3 months; a single TST will be administered and represents the second stage of two-step testing.” A review of PF’s was conducted on July 23, 2024 starting at approximately 10:00 AM. The date of hire (DOH) is indicated below. PF#1 DOH 02/27/2024 contained a one step TST administered on 02/27/2024. There was no evidence of a second TST contained in the file. PF#2 DOH 09/10/2022 contained a one step TST administered on 07/27/2022. There was no evidence of a second TST contained in the file. PF#3 DOH 12/06/2023 contained a one step TST administered on 02/20/2024. There was no evidence of a second TST contained in the file. An interview conducted with the administrator, clinical nurse manager, medical director, regional home manager, regional operations director, and group facility administrator on July 24, 2024 at 1:00 PM confirmed the above findings.”