Davita Barbour County Dialysis

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 30952 Based on observations, and interview it was determined the facility failed to ensure expired supplies were not available to patient use in the Home PD (peritoneal dialysis) Training rooms. This had the potential to negatively affect the four home PD patients treated at the facility. Findings include: The PD Home Training room tour was conducted on 12/4/23 at 11:30 AM. The surveyor observed two Home Training rooms. Found in Home Training room one was one bottle of ExSept, antimicrobial exit site cleanser, and the expiration date printed on the bottle was 9/21/23, and one bottle of Alcavis 50 (high-level disinfectant used to scrub/soak the external PD catheter). The opened date documented on the Alcavis bottle was 3/21/23, and the discard date documented on the bottle was 9/21/23. The Alcavis and ExSept had expired and were available for patient use. An interview was conducted on 12/4/23 at 1:30 PM with Employee Identifier # 2, Senior Manager of Clinical Services who confirmed the ExSept and Alcavis had expired.”

“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: 30952 Based on observations, review of facility policy, and staff interview, it was determined the facility failed to ensure staff followed the facility policy for hand hygiene prior to parenteral medication preparation. This did affect PI (Patient Identifier) # 3, in two of two single dose IV (intravenous) medication preparation observations and had the potential to negatively affect all eighteen patients who dialyzed at this facility. Findings include: In-center Hemodialysis Policy: 1-05-01 Title: Infection Control for Dialysis Facilities Revision Date: April 2023 Hand Hygiene 1. All teammates...will perform hand hygiene ...g. before touching clean areas such as supplies... Facility Hygiene 16. Clean areas...designated for preparation, handling, and storage of medications... 1. An observation of IV medication preparation was conducted on 12/4/23 at 12:10 PM with EI (Employee Identifier) # 3, Registered Nurse. EI # 3 exited the treatment floor and entered the medication preparation (med prep) area, gathered supplies, and prepared IV Venofer (for the treatment of low iron and IV Argatroban (an anticoagulant for the treatment of heparin-induced Thrombocytopenia, which is a low platelet count). At 12:11 PM, EI # 3 entered station 4, initiated the IV Argatroban via infusion and at 12:13 PM EI # 3 administered IV Venofer to PI # 3. EI # 3 failed to perform hand hygiene prior to touching the clean supplies in the medication preparation area and preparing IV Venofer and IV Argatroban. An interview was conducted on 12/6/23 at 11:00 AM with EI # 1, Facility Administrator who confirmed staff failed to follow the facility policy and perform hand hygiene before touching clean supplies in the med prep area.”

“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: 30952 Based on observation, and staff interview, it was determined the facility failed to ensure patients dialyzed in a safe environment. This did affect the eight patients dialyzing on 12/4/23 and had the potential to negatively affect all eighteen in-center patients who dialyze at the facility. Findings include: 1. Upon arrival to the facility on 12/4/23 at 8:20 AM, the surveyor observed the door to the dialysis treatment floor propped open with a door stop, which would allow unauthorized individuals access to the treatment floor. The facility failed to ensure patients dialyzed in a safe environment. An interview was conducted on 12/4/23 at 8:25 AM with Employee Identifier # 3, Registered Nurse, who reported the treatment room door was broken. An interview was conducted on 12/6/23 at 11:00 AM with EI # 1, Facility Administrator who confirmed the dialysis treatment floor was not secured while patients dialyzed.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 30952 Based on medical record (MR) review and interview, it was determined the facility failed to ensure staff followed provider (physician) instructions for prn (as needed) Clonidine administration. This did affect PI (Patient Identifier) # 4 in one of four in-center record reviews and had the potential to negatively affect all eighteen in-center patients who dialyze at the facility. Findings include: 1. PI # 4 was admitted to the facility on 12/1/21 with a diagnosis of End Stage Renal Disease. Review of the IDT (interdisciplinary) Rounding Worksheet documentation revealed PI # 4 dialyzed three times a week. Further review of the IDT Rounding Worksheet revealed the active in-center medications included Clonidine 0.10 mg (milligram) every hour prn, start 9/20/23, provider (physician) instructions give 0.1 mg (milligram) if SBP (systolic blood pressure) > (greater than) 170 and pulse > 60 after 1 hour (hr) of UF (ultrafiltration-removal of fluid/toxins). If HTN (hypertension) not resolving after 1 hour contact provider. Review of the Treatment Details Report (TDR) dated 11/17/23 revealed the following documentation: 5:40 AM pre-treatment BP (blood pressure) 147/71, heart rate (equivalent to pulse rate) 75 5:46 AM BP 156/76 started treatment 7:01 AM BP 174/81, pulse 73, bp recheck 7:16 AM BP 166/82 asymptomatic... 7:41 AM BP 163/104, pulse 78, asymptomatic for high dbp (diastolic bp) 8:41 AM BP 183/96, pulse 70 bp recheck 8:47 AM BP 189/90, pulse 77, asymptomatic for...sbp (systolic blood pressure) 8:48 AM, treatment ended (no bp documented) 8:55 AM post treatment vitals BP 182/88, pulse 75, asymptomatic for high bp...no complaints... There was no documentation prn Clonidine was administered (or offered) for SBP> 170 and no documentation the provider was contacted for SBP not resolved after 1-hour UF. Review of the TDR dated 11/20/23 revealed the following documentation: 5:59 AM pre-treatment vitals BP 184/76, pulse 67, complain of nausea, no emesis (vomiting)...elevated bp ...will monitor 6:14 AM treatment started BP 165/75, pulse 68 6:21 AM BP 175/87, pulse 70 6:41 AM BP 171/86, pulse 68 asymptomatic for high bp 7:21 AM BP 171/84, pulse 69 7:41 AM BP 177/88, pulse 69, no distress 8:41 AM BP 170/83 pulse 74, asymptomatic for...sbp 9:01 AM BP 158/83 9:14 AM, treatment ended BP 149/75, pulse 73 9:18 AM post treatment vitals BP 173/96, pulse 75, bp elevated post tx (treatment)...be sure to take bp med (medication) on arrival home... There was no documentation prn Clonidine was administered (or offered) for SBP> 170 and no documentation the provider was contacted for SBP not resolved after 1-hour UF. Review of the TDR documentation dated 11/22/23 revealed the following: 5:30 AM pre-treatment BP 164/86, heart rate (pulse) 76, asymptomatic for high bp 5:49 AM treatment started BP 165/91, pulse 71 8:01 AM BP 172/88, pulse 76, bp increased w/o (without) sx (symptoms) 8:50 AM BP 165/86, treatment terminated 8:54 AM post treatment BP 183/94, pulse 76, stable on d/c (discharge) asymptomatic for high bp... There was no documentation prn Clonidine was administered (or offered) for SBP> 170 and no documentation the provider was contacted for SBP not resolved after 1-hour UF. Review of the TDR documentation dated 11/27/23 revealed the following: 5:23 AM pre-treatment vitals BP 195/97, heart rate (pulse) 78 elevated bp pre tx w/o sx will monitor w/uf 5:54 AM BP 165/79 treatment started 6:00 AM treatment started, BP 179/90 pulse 72 elevated bp without sx continue will monitor Next electronic entry the time was illegible due to hole punch in the paper-entry made between 6:00 AM and 6:41 AM, 175/82 pulse 72, remains asymptomatic for high bp 8:20 AM BP 170/85, pulse 74 denies complaints with sbp >20 8:41 AM 175/86 pulse 85 8:55 AM treatment end BP 176/86, pulse 75 8:57 AM post treatment vitals BP 175/102, pulse 77, bp elevated post tx w/o symptoms...has bp med due on arrival home, he/she is stable on discharge.. prolonged bleeding post treatment, certified nurse practitioner notified, and transported to ER (emergency room) via ambulance... There was no documentation prn Clonidine was administered (or offered) for SBP> 170 and no documentation the provider was contacted for SBP not resolved after 1-hour UF. Review of the TDR dated 11/29/23 revealed the following documentation: 5:23 AM pre-treatment vitals BP 180/97, heart rate 78, elevated bp pre tx w/o sx monitor w (with) uf 5:47 AM treatment started BP 186/89, pulse 76 6:01 AM BP 166/82, pulse 80 bp improving cont (continue) to monitor 6:20 AM BP 173/85, pulse 80 6:41 Am BP 174/86, pulse 78 8:00 AM BP 171/89, pulse 78 alert w/o complaints 8:21 AM BP 174/86, pulse 79 no distress noted 8:47 AM BP 170/81 pulse 70 treatment terminated 9:24 AM post treatment vitals BP 180/90, pulse 76, elevated bp post tx w/o sx... There was no documentation prn Clonidine was administered (or offered) for SBP> 170 and no documentation the provider was contacted for SBP not resolved after 1-hour UF. Review of the TDR dated 12/01/23 revealed the following documentation: 5:38 AM pre treatment vitals BP 163/98, heart rate 86, elevated bp pre tx will monitor w/uf 5:48 AM BP 182/83, pulse 69 treatment started... 6:01 AM BP 194/87, pulse 73 6:20 AM BP 170/95, pulse 74 bp improved w/o sx noted cont to monitor 6:40 AM BP 180/89, pulse 74 BP fluctuating w/o c/o; cont to monitor 7:20 AM BP 173/86, pulse 82 8:00 AM BP 174/88, pulse 83 8:49 AM BP 186/92, pulse 62 treatment terminated 8:55 AM post treatment vital signs BP 186/93, pulse 82, elevated bp post tx w/o sx stable on discharge... There was no documentation prn Clonidine was administered (or offered) for SBP> 170 and no documentation the provider was contacted for SBP not resolved after 1-hour UF. The post treatment BPs in six of six treatments was greater than 170 SBP and there was no documentation prn Clonidine administered. An interview was conducted on 12/6/23 at 9:44 AM with Employee Identifier # 1, Facility Administrator who confirmed there was no documentation staff followed physician orders for prn Clonidine administration.”

“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: 30952 Based on review of facility policy, the facility Peritoneal Dialysis (PD) Antibiotic Stewardship Protocol Revised (Rev) 3.0, medical record (MR) and interview, it was determined the facility failed to ensure home PD treatment records were complete and accurate, such that the staff were able to determine patient compliance with physician ordered treatments. This did affect Patient Identifier (PI) # 5, in one of one PD record reviews, and had the potential to affect all four PD patients treated at this facility. Findings include: Facility PD Policy: 5-07-01 Title: Medication Policy Revision Date: October 2022 ...Purpose: To provide guidance for medication management... NOTE: All prescriptive medication including...Heparin, antibiotics and saline for patient use at home...distributed...from a licensed pharmacy. Patient will record use of medications on their home treatment records... Facility PD Antibiotic Stewardship Protocol Revised 3.0 Date: 12/1/22 ...The PD Antibiotic Stewardship Protocol for the treatment of peritonitis is designed to prevent medication errors...optimize patient outcomes... Treatment and follow-up ...Special Conditions: ...3...First Line Antibiotic IP (intraperitoneal) Cefazoline AND IP Ceftazidime (dual therapy)... ...If...allergic to...IP Ceftazidime, start an alternate antibiotic...as follows: Alternate IP Vancomycin... 1. PI # 5 was admitted to the facility on 5/14/21 with a diagnosis including End Stage Renal Disease. PI # 5 performed home PD. Review of the IDT (Interdisciplinary) Rounding Worksheet revealed PI # 5 had a documented allergy to Fortaz (Ceftazidime), dialyzed via a PD catheter, and the PD treatment order type was Continuous Cycler Peritoneal Dialysis (CCPD). Further review of the IDT Rounding Worksheet revealed Protocol Orders for Heparin IP (intraperitoneal) 1,000 units one time a day, start date 1/30/23, and PD Antibiotic Stewardship Protocol Rev. 3.0, start date 7/16/23. Review of the Daily Home Continuous Cycler (DHCC) PD Record documentation completed by PI # 5, dated July 1-31, 2023, revealed no documentation IP Heparin daily was administered. There was no documentation the PD RN (Registered Nurse) instructed PI # 5 to document IP Heparin administration on the home treatment record. Review of the DHCC PD Record documentation dated August 1-31, 2023, revealed no documentation PI # 5 administered IP Heparin daily. There was no documentation the PD RN instructed PI # 5 to document IP Heparin administration on the home treatment record. There was no September 2023 DHCC PD Record documentation provided to the surveyor. MR review included Patient Note (PN) documentation dated 10/24/23 at 4:11 PM completed by the PD RN which revealed the following: PI # 5 was in the clinic for workup with cloudy effluent, abdominal pain, and PD effluent had been collected. Patient was instructed on IP antibiotic administration and given a box of needles. Patient stated she/he uses heparin every night. Treated with Ceftazidime and Cefazolin. NP (nurse practitioner) made aware. Record review revealed a PN dated 10/25/23 at 8:21 AM completed by the PD RN which revealed the PD RN talked to PI # 5, advised PI # 5 to stop Ceftazidime, and start Vancomycin. Pt (patient) verbalized understanding. MR review revealed a PN dated 10/26/23 at 8:51 AM completed by the PD RN with orders from the NP to continue Vancomycin 1000 mg every 4 days per protocol until final results available. Review of the DHCC PD Record documentation dated October 1-31, 2023, and November 1-27, 2023, completed by PI # 5 revealed no home record documentation for the administration of daily IP Heparin, Ceftazidime IP, and Vancomycin IP. There was no documentation the PD RN instructed PI # 5 to document the use of medications on the home treatment record. An interview was conducted on 12/5/23 at 11:44 AM with Employee Identifier # 4, Regional Home Program Manager, who confirmed there was no home record documentation for IP Heparin, Ceftazidime and Vancomycin, and no documentation the PD RN instructed the patient to document medications administered on the home treatment record.”

“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: 30952 Based on review of medical records (MR), facility policies, and interview, it was determined the Medical Director failed to ensure the Registered Nurse (RN) followed the facility policies and: 1. Reported a medication error to the physician once the error was identified, which did affect PI (Patient Identifier) # 5, in one of one home PD (peritoneal dialysis) record reviews. 2. Performed and documented an initial nurse assessment evaluation prior to initiation of the first in-center dialysis treatment, which did affect PI # 3, in one of one in-center new patient record reviews. This had the potential to negatively to affect all patients admitted to this facility. Findings include: Facility PD Policy: 5-07-01 Title: Medication Policy Revision Date: October 2022 ...Purpose: To provide guidance for medication management... ...9. Prior to administration of medication...verify order. Check for patient allergies when receiving or entering a medication order and prior to administering any medication. ...17... ...r. All medication errors are reported to the Facility Administrator (FA)/designee...then notify the patient’s physician of the event and of any adverse changes in the patient’s condition... s. The FA...will be responsible, after consultation with the physician, for implementing any necessary action to counteract the error and prevent a reoccurrence. Facility In-center Policy: 1-03-07 Title: CWOW (centers without walls)- Initial Nursing Assessment for New Patients Revision Date: October 2021 ...Purpose: To provide guidance for all new patients to be evaluated by a RN prior to the initiation of their first treatment at the facility. Policy: 1. A...RN as required by federal regulation will perform an initial pre-treatment evaluation of all new patients prior to initiation of their first treatment at the facility... 2. The minimal nursing evaluation prior to initiating treatment for a new patient... 4. This initial pre-treatment evaluation will be documented as the Initial Patient Nursing Assessment... 1. PI # 5 was admitted to the facility on 5/14/21 with a diagnosis including End Stage Renal Disease (ESRD). PI # 5 performed home PD. Review of the IDT (Interdisciplinary) Rounding Worksheet revealed PI # 5 had a documented allergy to Fortaz (trade name is Ceftazidime) and dialyzed with a PD catheter. Further review of the IDT Rounding Worksheet revealed active protocol orders which included PD Antibiotic Stewardship Protocol, Revised 3.0, start date 7/16/23. Review of the PD medication orders documentation revealed Ceftazidime (Fortaz) 1000 milligram (mg) one time only, IP (intraperitoneal), dated 10/24/23, administered at the dialysis facility by the PD RN. MR review revealed Patient Note (PN) documentation dated 10/24/23 at 4:11 PM completed by the PD RN that revealed PI # 5 was in the clinic for workup due to cloudy effluent due to abdominal pain, PD effluent had been collected, PI # 5 was instructed on IP antibiotic administration, and was treated with Ceftazidime (Fortaz) and Cefazolin. NP (Nurse Practitioner) made aware. The IDT Rounding Worksheet documentation revealed PI # 5 had a documented allergy to Fortaz. There was no documentation the NP was informed PI # 5 had an allergy to Fortaz. Review of the PN dated 10/25/23 at 8:21 AM revealed the PD RN talked to PI # 5, advised PI # 5 to stop Ceftazidime, start Vancomycin. Pt (patient) and threw (throw) out the Ceftazidime. There was no documentation the physician/NP was informed PI # 5 received Ceftazidime at the facility, was prescribed for home use, and had a documented allergy to Fortaz. An interview was conducted on 12/5/23 at 3:57 PM with Employee Identifier (EI) # 4, Regional Home Program Manager, who confirmed there was no documentation the PD RN informed the physician/NP of the medication error once the Fortaz allergy was identified. EI # 4 reported the PD RN completed a medication error event on 10/25/23, that the physician would have review all occurrences at the monthly quality meeting on November 28, 2023, which was more than 30 days after the medication error occurred. 2. PI # 3 was admitted to the facility on 11/3/23 with a primary diagnosis of ESRD. Review of the Treatment Details Report dated 11/3/23 revealed the initial facility dialysis treatment started at 2:41 PM, the pre-treatment assessment was completed at 2:45 PM, and the initial patient nursing assessment was completed on 11/3/23 at 3:42 PM, which was 61 minutes after the initial dialysis treatment start time. An interview was conducted on 12/6/23 at 11:16 AM with EI # 1, Facility Administrator, who confirmed staff failed to document initial RN assessment findings prior to the initial dialysis treatment initiation.”