Davita Lancaster SC 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: 30011 Based on observations, interview, and review of facility policy and procedure, the dialysis facility failed to ensure staff donned gloves when touching the dialysis machine and perform hand hygiene between changing gloves for 1 of 1 Certified Clinical Hemodialysis Technician (CCHT 3) observed. The findings include: Observations on 01/09/24 at 1:34 PM in the dialysis treatment room revealed Certified Clinical Hemodialysis Technician (CCHT) 3 placed a clean glove around one finger and silenced the dialysis machine alarm in dialysis station #25, discarded the glove, and placed another clean glove around his/her finger and silenced the dialysis machine alarm at dialysis station #27 with no hand hygiene. During an interview on 01/09/24 at 12:32 PM, CCHT 3 stated, “We are to put gloves on every time we touch the machine”. Facility policy, entitled, “Infection Control For Dialysis Facilities”, revealed, “1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene...b. prior to gloving and immediately after removal of gloves...7. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station...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...”. 22313 Observations on 1/9/24 at 10:30 AM revealed the patient in dialysis station 17 was having the dialysis initiated by CCHT 3. CCHT 3 removed the blood line, reached up to push the armed television back away from the patient, and then attached the blood line to the dialysis machine. CCHT 3 removed his/her gloves, retrieved a clean glove from the box but does not don the clean glove, reaches across to an adjacent dialysis station/dialysis machine and simply holds the glove while pushing buttons on the second dialysis machine. CCHT 3 tossed the glove into the trash and returned to the dialysis station 17, dons the clean gloves without performing hand hygiene and proceeds to set up the dialysis machine.”

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 30011 Based on observations, interviews, and review of facility policy and procedure, the dialysis facility failed to ensure external wet transducer protectors were changed in a timely manner for 2 of 2 dialysis stations observed with wet external transducer protectors. (Dialysis station 1 and 14) The findings include: Random observations on 01/09/24 at 9:00 AM in the dialysis treatment room revealed a wet external transducer protector at dialysis station 1. 9:01 AM: Registered Nurse (RN) 1 was in dialysis station 1 to silence the dialysis machine alarm but did not address the external wet transducer protector. 9:02 AM: RN 1 returned to dialysis station 1 to place the patient on Oxygen via nasal cannula and to change the bibag on the dialysis machine but did not address the external wet transducer protector. 9:09 AM to 9:10 AM: RN 1 returned to dialysis station 1 to silence a dialysis machine alarm but did not address the external wet transducer protector. 9:35 AM:, Certified Clinical Hemodialysis Technician (CCHT) 4 was observed in dialysis station 1 with alarm reading “Blood pump stopped” to restart the dialysis machine but did not address the wet external transducer protector. 10:05 AM: the patient’s dialysis treatment completed. CCHT 4 entered dialysis station 1 to re-infusion extracorporeal blood. When observing the back of the external wet transducer protector prior to CCHT 4 discarding it, there was no breakthrough observed. During an interview on 01/09/24 from 10:06 AM to 10:07 AM, CCHT #4 stated, “The transducer is wet on the front, but we don’t know if there’s breakthrough until we look at the back.” Random observation on 01/09/24 at 9:01 AM in the dialysis treatment room revealed a wet external transducer protector at dialysis station 14. 9:02 AM: Registered Nurse (RN) #2 is in Dialysis station 14 but did not address the wet transducer. 9:30 AM: CCHT #5 went to dialysis station #14 to talk with the patient but did not address the wet transducer. 9:45 AM: CCHT #4 went to the dialysis machine to silence the machine alarm but did not address the wet transducer. 9:46 AM: CCHT #5 to the dialysis station with the machine alarming, but did not address the wet transducer. 10:25 AM: CCHT #3 to dialysis station 14 to silence the dialysis machine alarm but no change to the wet transducer. 11:10 AM: CCHT #5 to dialysis station 14 to silence the dialysis machine alarm with no change to the wet transducer transducer. 11:40 AM: CCHT #3 to dialysis station 14 to discontinue treatment for the patient. Observation of back of the wet transducer showed no breakthrough. During an interview on 01/01/24 at 12:33 PM, CCHT 3 stated, “We check the dialysis machines every 30 minutes with blood pressure checks. If the transducer is wet, we change them”. Facility policy, entitled, “Changing Transducer Protectors”, revealed, “3. External transducer protectors will be inspected for presence of blood or saline every 30 minutes during patient treatment and included as part of the monitoring process. 4. The external transducer protector will be replaced:...Whenever blood or saline is observed in contact with the patient side of the transducer protector...”. Facility policy, entitled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, revealed, “f. External transducer protectors will be inspected for presence of blood or saline every 30 minutes during patient treatment and included as part of the monitoring process...”.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [The facility must demonstrate that it follows standard infection control precautions by implementing-] (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 22313 Based on observations, interview, and review of the facility’s policies and procedures,1 of 1 Certified Clinical Hemodialysis Technician (CACHET 1) failed to adhere to accepted principle of Infection Control when terminating the patient’s dialysis. The findings are: Observations on 1/08/24 at 10:21 AM in dialysis station 11 revealed the patient had a femoral access site that was covered up. CACHET 1 moves the trash can, uncovers the patient’s access site, places tape strips on the isolation room window which is next to the patient’s chair, lays gauze pads on the patient’s pants, pulls the pants down low enough to access the site, de-cannulates the patient’s access, and places the gauze pads on top of the access site. After five minutes of holding pressure, CCHT 1 reaches for the larger gauze pad lying on the patient’s lap, grabs the tape from the isolation room window, and places the large gauze pad on the site. When CCHT 1 was asked about the placement of the tape and gauzes, CCHT 1 said, “Yeah, she/he’s just really hard to handle.” Facility policy 1-03-12 A, entitled, Termination of Dialysis, reads, “16. Perform Post-Dialysis care per procedure”. Observations in the dialysis treatment room on 1/9/24 at 9:15 AM revealed the Sharps containers at dialysis station 1, 14, 15, 19, 20, 21, 23, 25 and 27 were observed with dirty syringes over the fill line and approaching the top opening. The finding was confirmed with Registered Nurse 1 in an interview 1/9/24 at 10 AM. Facility Policy 4-03-07, entitled, Segregation of Medical Wastes, reads, “5. Sharps containers are to be sealed when 3/4 full and placed in designated area for medical waste pickup”.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 30011 Based on random observations, interview, and review of facility policy and procedure, the dialysis facility failed to ensure stethoscopes were disinfected after patient use for 1 of 1 Registered Nurse (RN 1) and the dialysis stations were disinfected properly by 1 of 1 Certified Clinical Hemodialysis Technician (CCHT) observed. (CCHT 5) The findings include: Observations on 01/09/24 at 10:20 AM in the dialysis treatment room revealed Certified Clinical Hemodialysis Technician (CCHT) 5 during disinfection/cleaning of dialysis station 19 used a 1:100 (one to one hundred) bleach cloth to wipe the right side of the dialysis chair, the trash can, and the biohazard needle box around the top and side, and then used the same bleach cloth to clean the left side of the dialysis chair without obtaining a clean bleach cloth after disinfecting the biohazard needle box. During an interview on 01/09/24 at 11:05 AM, CCHT 5 stated, “I didn’t realize I was doing that.” 22313 During random observations in the dialysis treatment room on 1/8/24 from 10:41 AM-12:30 PM and on 01/09/2024 from 8:45 AM to 10:11 AM, random observations revealed Registered Nurse 1(RN) failed to sanitize equipment (stethoscope) used between patients and returned the stethoscope to the neck after use. Facility policy 1-05-01, reads, “14. Non-disposable items (stethoscopes) are to be disinfected after each patient use, prior to removal from the station/patient.””

“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: 22313 Based on observations, record reviews, and interview, the facility failed to ensure proper infection control techniques/procedures are employed per policy. The findings are: Random observations on 1/8/24 at 11:40 AM in dialysis station 5 revealed Registered Nurse (RN)1 did not ‘scrub the hub’ when administering intravenous medications to the patient at Dialysis Station 13. Random observations on 1/9/24 at 11:00 AM revealed Patient Care Technician (PCT) 5 drew a blood sample from the patient’s line and then flushed the line with saline without cleaning the hub with an alcohol pad. Facility policy, 1-06-01A, page 8 under 8, entitled, “Administering medication”, reads, “a. Placing an alcohol prep pad over the opening on the saline infusion lock site, b. ...pushing the alcohol prep pad down firmly into the saline infusion line, c. pressing firmly and rotating for 30 seconds, d. removing and discarding the alcohol prep pad”. Further, “cleanse the Locksite prior to each IV medication administration”.”

“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: 22313 Based on observations and interview, the facility failed to ensure there were no expired supplies available for patient use. The findings are: Observations on 1/8/24 at 12:00 PM revealed the following expired supplies were stored in the water room storage area: 3 boxes of Criterion poly gloves size 7, 50 pairs in each box, expired 10/14/23 3 bags of Baxter LoCal 2.5 Dex expired 9/23 3 Deflex solution 4.5 expired 10/23, 1 Deflex solution 2.5 expired 12/23 3 boxes of Pro glucose control solution expired 11/20/23 The entire storage area had a large number of empty boxes stacked up blocking access to the outside. The Facility Administrator confirmed the findings on 1/8/24 at 12:45 PM. During observations of the clinic on 1/8/24 at 10:10 AM, 2 bottles of RPC E-Z-Chek Total Chlorine/Chloramines Test Strips were not dated when opened. The test strips are highly sensitive and used to test Chlorine levels in the water used in the dialysis machines. Registered Nurse 1 concurred with the findings in a short interview at the time of discovery in addition to the expired supplies. Manufacturers guidelines, read, “Proper use procedures, including storage and handling, must be documented to ensure accurate test results”. Observations on 01/08/24 at 11:59 AM in the facility supply room revealed (6) boxes of Renal Pure Powder Bicarbonate expired on 11/17/23. During an interview on 01/08/24 at 12:00 PM, Registered Nurse (RN) 1 stated, “We used to use this to make the Bicarb (Bicarbonate) but we don’t do that anymore.””

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 22313 Based on observations, record review, and interviews, random observations in the dialysis treatment room revealed dialysis staff failed to ensure patient access sites were in view of the dialysis staff for 11 random patients undergoing treatment. The findings are: During random observations on 1/8/24 - 1/9/24 from 9:30 AM - 12:00 PM, 11 random patients receiving dialysis did not have their access sites uncovered. Several staff were observed to check the patients/dialysis machines over 3 hours of treatments. No staff requested the patients to uncover their access sites. In an interview with the Facility Manager (FA) on 1/11/24 at 10:00 AM, she/he confirmed patients often cover their access sites during their treatments. Facility policy, 1-03-08 under 8., reads, “Licensed Nurse will ...b. At a minimum, obtain and document. ......v. Vascular access visible and line connections intact.””

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 22313 Based on record reviews, interviews, and review of facility policy and procedure, the facility failed to ensure patients’ initial Plan of Care (POC) were completed within 30 days or 13 patient treatments for 2 of 11 home therapy patient charts reviewed. (Patient 1 and 12) The findings are: Record review for Patient #1, a home dialysis patient with a start date of 10/13/23 revealed the patient’s POC was dated 11/15/23 with the physician’s signature dated 12/12/23. The patient’s first review by the Interdisciplinary Group was 12/15/23. The finding was confirmed with the Facility Administrator on 1/11/24 at 12:50 PM. Record review on 01/11/24 at 9:39 AM revealed Patient 12 was admitted to the home Peritoneal Dialysis (PD) program on 06/09/23 for End Stage Renal Disease (ESRD). The patient’s initial comprehensive assessment was not completed by the Interdisciplinary Team (IDT) until 07/12/23 which was 30 days past when Patient 12 was admitted to the home program. During an interview on 01/11/24 at 12:04 PM, the Facility Administrator (FA) verified the findings. Facility policy, entitled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care”, revealed, “4. A comprehensive assessment will be conducted on all new patients within 30 (thirty) calendar days (or 13 (thirteen) outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines...”.”

“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: 30011 Based on record reviews, interview, and review of the facility’s policy and procedure, the dialysis facility failed to ensure 1 of 2 Peritoneal dialysis (PD) patients reviewed received an unstable comprehensive plan of care (POC) after an unstable POC designation by the Interdisciplinary team (IDT). (Patient 2) The findings include: Record review on 01/10/24 at 9:36 AM revealed Patient 2 was admitted to the home PD program on 05/17/17 with a diagnosis of Hypertension/Large vessel disease. Review of the patient’s chart revealed an unstable “Patient Plan of Care” dated 09/26/23 by the IDT with no documentation of a POC for the month of October 2023. During an interview on 01/11/24 at 1:56 PM, the Facility Administrator (FA) stated, “No POC was done for October 2023.””

“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: 30011 Based on record reviews, interview, and review of the facility’s policy and procedure, the dialysis facility failed to ensure the ultrafiltration rate for 1 of 9 in-center patients (Patient 12) was not exceeded during dialysis treatment. The findings include: Record review on 01/11/24 at 9:39 AM revealed Patient 12 was admitted to the dialysis facility for End Stage Renal Disease (ESRD). Patient 12 presented with a 10.3 % (percent) IDW (intradialytic weight gain) on 07/19/23. Review of the patient’s dialysis treatment sheet dated 07/19/23 revealed “ordered maximum ultra filtration rate” for the patient noted as “13.0 ml (milliliter)/kg (kilogram)/hr (hour)”. Patient 12’s dialysis treatment time was 4 hours and weight for the day was 62.2 kgs which meant the total volume of fluid to be removed was 3234 mls. Review of the patient’s dialysis treatment sheet showed Patient 12 dialyzed for 2 hours and 45 minutes from 1:04 PM to 3:42 PM with 4418 mls removed during dialysis treatment which was 1194 ml over the amount of fluid to be removed. During an interview on 01/11/24 at 12:04 PM, the Facility Administrator (FA) verified the findings. Record review on 01/11/24 at 9:39 AM revealed Patient 12 presented with a 4.5 % (percent) IDW (intradialytic weight gain) on 07/24/23. Review of the patient’s dialysis treatment sheet dated 07/24/23 revealed “ordered maximum ultra filtration rate” for the patient showed as “13.0 ml (milliliter)/kg (kilogram)/hr (hour)”. Patient 12’s dialysis treatment time was 4 hours and weight for the day was 60.6 kgs which meant the total volume of fluid to be removed was 3151 mls. Review of the patient’s dialysis treatment sheet showed Patient 12 dialyzed for 3 hours from 12:05 PM to 3:05 PM with 4001 mls removed during dialysis treatment which was 850 mls over the amount of fluid to be removed. During an interview on 01/11/24 at 12:04 PM, the FA verified the findings.”

“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: 30011 Based on record reviews, interviews, and review of the facility’s policy and procedure, the dialysis facility failed to ensure the blood flow rate (BFR) and/or dialysis flow rate (DFR) was administered per the physician prescription for 4 of 10 patient charts reviewed. (Patient 4, 8, 10, and 11) The findings include: Record review on 01/10/24 at 2:01 PM revealed Patient 4 was admitted on 06/29/21. Patient 4’s dialysis prescription was for a blood flow rate (BFR) 400. Review of the patient’s dialysis treatment sheets revealed: 12/18/23--BFR 350 12/29/23--BFR 350 01/08/24--BFR 300-350 During an interview on 01/11/24 at 11:27 AM, the Facility Administrator (FA) verified the findings. Record review on 01/10/24 at 2:45 PM revealed Patient 8 was admitted on 03/09/22. Patient 8’s dialysis prescription was for a dialysis flow rate (DFR) of 700. Review of patient’s dialysis treatment sheets revealed the following: 12/28/23--DFR 500 01/05/24--DFR 500 01/08/24--DFR 300 During an interview on 01/11/24 at 11:38 AM, the FA verified the findings. Record review on 01/10/24 at 3:15 PM revealed Patient 10 was admitted (ESRD) and Type 2 diabetes mellitus on 12/08/21. Patient 10’s dialysis prescription was for a blood flow rate (BFR) 400. Review of the patient’s dialysis treatment sheets revealed the following: 12/22/23--BFR 350 12/29/23--BFR 300-350 01/01/24--BFR 300-350 During an interview on 01/11/24 at 11:49 AM, the FA verified the findings. Record review on 01/11/24 at 9:04 AM revealed Patient 11 was admitted to the facility for End Stage Renal Disease (ESRD) on 06/01/15. Patient 11’s dialysis prescription was for a blood flow rate (BFR) of 450. Review of the patient’s dialysis treatment sheets revealed the following: 12/22/23--BFR 400 12/27/23--BFR 400 12/29/23--BFR 400 01/01/24--BFR 400 01/03/24--BFR 400 01/05/24--BFR 400 During an interview on 01/11/24 at 11:57 AM, the Facility Administrator (FA) verified the findings. Facility policy, entitled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, revealed, “10. If the dialysis prescription is not being met (including dialysis flow rate to change to /inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed...”.”

“POC-PT/FAMILY EDUCATION & TRAINING CFR(s): 494.90(d) The patient care plan must include, as applicable, education and training for patients and family members or caregivers or both, in aspects of the dialysis experience, dialysis management, infection prevention and personal care, home dialysis and self-care, quality of life, rehabilitation, transplantation, and the benefits and risks of various vascular access types. This Standard is not met as evidenced by: 22313 Review of 5 of 10 patient charts for Infection Control Training revealed the facility had not demonstrated Infection Control education for these patients. (Patient 1, 5, 6, 7, and 9) The findings are: Record review on 1/11/24 at 1:00 PM for Patient 1, 5, 6, 7, and 9 revealed there was no documentation in the patient charts that the patients received Infection Control training. The findings were confirmed in an interview with the Facility Administrator on 1/11/24 at 2:00 PM.”

“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: 30011 Based on record reviews and interview, the home therapy program failed to monitor the patient’s dialysis treatment sheets for 1 of 2 home therapy patient charts reviewed. (Patient 2) The findings include: Record review on 01/10/24 at 9:36 AM revealed Patient 2 was admitted to the home therapy program for Peritoneal Dialysis (PD) on 05/17/17 for Hypertensive/Large vessel disease. Review of the patient’s home therapy chart revealed home dialysis treatment sheets for December 2023 were dated from 12/01/23 to 12/19/23 with no additional information. The home therapy nurse signed the form verifying review of the data on 01/02/24. During an interview on 01/11/24 at 1:34 PM, the Facility Administrator stated, “The patient came for clinic day on 01/02/24, and no additional documentation was provided by the patient.””