Davita Cypress Gardens Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 30011 Based on observation, interview and review of facility policy and procedure, the dialysis facility failed to ensure the testing of the water quality was completed appropriately by knowlegeable staff. The findings include: Cross Reference to V0196: The dialysis facility failed to ensure 3 of 4 staff members performed the total chlorine monitoring for the water system according to manufacturer’s guidelines. Cross Reference to V0197: The dialysis facility failed to ensure 3 of 3 Patient Care Technicians was able to identify the maximum allowable limit for total chlorine in the dialysis quality water.”

“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: 30011 Based on observation and interview, the dialysis facility failed to ensure the patient medication refrigerator was not located in the dirty laboratory area located beside the nursing station in the facility. The findings include: Observation on 5/20/24 at 9:20 AM of the treatment room floor revealed a patient medication refrigerator located in the lab area next to the lab refrigerator noted with used blood collection tubes. Further observation revealed a clean sink located beside (2) centrifuge machines on the countertop above the patient medication refrigerator. During an interview on 5/23/24 at 3:00 PM, the Facility Administrator stated, “I don’t know why the medication refrigerator is located in the lab area”.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 30011 Based on observations, interviews, and review of manufacturer’s guidelines, the dialysis facility failed to ensure 3 of 4 staff members performed the total chlorine monitoring for the water system according to the manufacturer’s instructions for use. (Patient Care Technicians (PCT) #1, #2 and #3). The findings include: Review of manufacturer’s guidelines entitled, “Ultra-Low Total Chlorine Test Strips” on 5/22/24 at 12:45 PM revealed, “1) Collect a fresh 100 ml (milliter) sample of water in clean plastic sample cup...2) Remove one test strip from its foil package and swish it in the sample for the amount of time indicated according to the following temperatures ranges...3) Remove the strip and shake once, briskly, to removes excess water. 4) Wait 20 seconds for the test strip color to develop. While waiting, fold the white plastic handle of the test strip under the reagent area aperture so that it provides a consistent viewing background. 5) After the 20 second wait period, immediately compare the strip color to the...color chart to determine the Total Chlorine level in the sample...”. Observation of the chlorine water check on 5/22/24 at 11:58 AM to 11:59 AM revealed PCT #1 along with observation by PCT #2 obtained a 100 ml sample of water from post primary carbon tank port. PCT #1 opened a total chlorine test strip, placed it in the water sample and swished it for 30 seconds. Post swishing of the test strip, PCT #1 immediately folded the strip in half and read the strip based on the color chart and stated the result was 0.00. PCT #1 failed to swish the strip in the water for 60 seconds then wait 20 seconds prior to reading the test strip. During an interview on 5/22/24 at 11:59 AM, PCT #1 stated, “We only swish the strip for 30 seconds and then we immediately read the strip”. During an interview at 12:00 PM, PCT #2 who observed stated, “I agree with the way he/she performed the test. That’s the way we do it”. Observation of the chlorine water check on 5/22/24 at 12:14 PM to 12:16 PM revealed PCT #3 along with observation by Registered Nurse (RN) #1 obtained over 100 ml sample of water from post primary carbon tank port. PCT #3 opened a total chlorine test strip, placed it in the water sample and swished it for 30 seconds. Post swishing of the strip, PCT #3 removed the test strip and immediately began to read the strip when RN #1 stated, “The strip should have been swished for 60 seconds”. RN #1 proceeded to open another test strip and perform the test. RN #1 swished the strip for 60 seconds, placed the strip together and then immediately read the results based on the color chart as 0.00. During an interview on 5/22/24 at 12:18 PM, RN #1 stated, “We are to swish the strip for 60 seconds”. During an interview on 5/22/24 at 12:18 PM, PCT #3 stated, “I wasn’t really looking at the clock when I was doing it and we didn’t wait for 20 seconds before reading the strip”.”

“CARBON ADSORP-ACTION IF FIRST TEST + CFR(s): 494.40(a) 5.2.5 Carbon adsorption: action if first test positive When samples from the first sampling port are positive for chlorine or chloramine, operation may be continued for a short time (up to 72 hours) until a replacement bed is installed, provided that samples from the second sampling port remain negative. The replacement bed should be placed in the second position, and the existing second bed should be moved to the first position to replace the exhausted bed. If it is not possible to rotate the position of the beds, both beds should be replaced. This Standard is not met as evidenced by: 30011 Based on observations, interviews, and review of facility policy and procedures, the dialysis facility failed to ensure 3 of 3 Patient Care Technicians was able to state the maximum allowable limit for total chlorine in dialysis quality water. (PCT #1, #2 and #3). The findings include: Observation on 5/22/24 at 11:58 AM to 11:59 AM of the chlorine water testing revealed PCT #1 performed the chlorine testing of the water and PCT #2 observed during the process. When asked the maximum allowable limits for the chlorine water testing, PCT #1 stated, “I really don’t know but I thing the maximum allowable limit is greater than 0.01. Anything more than 0.01 we will recheck the water and if its high then we check at the post carbon port past the secondary carbon tank. PCT #2 stated, “What PCT #1 stated is correct and I agree with that”. Observation on 5/22/24 at 12:14 PM to 12:18 PM of the chlorine water testing revealed PCT #3 performed the chlorine water testing and Registered Nurse (RN) #1 observed during the process. When asked the maximum allowable limits for the chlorine water testing, PCT #3 stated, “Greater than 0.01” and RN #1 stated, “0.10 is action level”. Review of personnel files on 5/22/24 at 1:20 PM revealed PCT #1 was deemed competent for “Total Chlorine Testing” on 3/20/24, PCT #2 was deemed competent on 3/20/24 and PCT #3 was deemed competent on 4/19/24. Facility policy, entitled “Daily Water System Total Chlorine Monitoring” revealed, “11. If the results of Total Chlorine testing from the primary carbon filter or set of tanks indicate a level of less than or equal to 0.1 ppm (parts per million) (<-0.1 ppm), Record results on the “Routine Total Chlorine Testing” log...a. If the results of Total Chlorine testing from the primary carbon filter indicate a level of greater than 0.1 ppm (parts per million) (>0.1 ppm), the test should be immediately repeated on a freshly drawn sample to verify the results are not a “false positive...”.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 30011 Based on observation, interview, review of facility policy and procedure and manufacturer guidelines, the dialysis clinic failed to ensure personnel staff labeled the Minncare disinfectant bottle post disinfection of the continuous water pressure (CWP) reverse osmosis (RO) machine and 1 of 2 Registered Nurses (RN #1) was checked off for competency to perform water testing for chlorine. The findings include: Observation on 5/20/24 at 9:04 AM of the Minncare bottle used to disinfect the CWP RO machine revealed a black mark noted on the bottle last dated 5/10/24. Signage on the CWP RO machine further revealed “Peractic Acid 5/16 at 12:00” with no black mark labeling a disinfection on 5/16/24. During an interview on 5/20/24 at 9:10 AM, the Biomedical Technician stated, “Staff are taught to use the signage to write down when they did the disinfection but also to mark the disinfectant bottle once they finish disinfections”. Facility policy, entitled “CWP Post Chemical Disinfect Start UP” revealed, “12. Mark the level of the disinfectant and the date on the Minncare disinfectant container, and verify that the disinfectant level is lower than the marking from the previous disinfection...”. Review of manufacturer guidelines revealed, “Step 6 Mark the fluid level and the date on the disinfectant container with a permanent marker...”. Review of RN #1’s personnel file on 5/22/24 at 1:20 PM revealed no documentation for total chlorine testing competency. Review of “Routine Total Chlorine Testing Log” revealed RN #1 documented “Verifying Each Test is Documented and Results Appropriate” on 5/17/24 at 12:45 PM and on 5/20/24 at 12:45 PM. During an interview on 5/22/24 at 12:35 PM, RN #1 stated, “I did check the water on Monday (5/20) because they were backed up”. During an interview on 5/22/24 at 12:20 PM, the Biomedical Technician stated, “RN #1 is not signed off yet (to check the water)”. During an interview on 5/22/24 at 1:30 PM, Facility B Clinic Manager stated, “Contract staff coming to the facility go through a check-off with the Biomed prior to doing water checks and RN #1 has not been checked off yet”.”

“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: 30011 Based on observations, interviews and review of facility policy and procedure, the dialysis facility failed to ensure expired supplies were removed from the patient care area. The findings include: Observation on 5/20/24 at 9:12 AM of the dialysis facility storage room revealed (250) 17 gauge x (by) 1 1/4 filter needles expired 1/31/22. During an interview on 5/20/24 at 9:15 AM, the Biomedical Technician verified the findings. Observation on 5/20/24 at 9:40 AM of the dialysis treatment room floor revealed (1) bottle of (50) EZ 6.8-8.5 pH test strips expired 4/30/24 . During an interview on 5/20/24 at 10:14 AM, Patient Care Technician (PCT) #4 stated, “Strips are used until the expiration”. Observation on 5/20/24 at 9:45 AM of the dialysis treatment room floor revealed (40) povidone-iodine prep pads expired 12/23. During an interview on 5/20/24 at 9:50 AM, Patient Care Technician (PCT) #3 verified the findings. Facility policy, entitled “Infection Control For Dialysis Facilities” revealed, “b. Expiration date and package integrity will be verified prior to use...”.”

“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 review, interview and review of facility policy and procedure, the dialysis clinic failed to ensure elevated blood pressures for 2 of 4 patient’s during treatment were reported to the physician. The findings include: Record review on 5/23/24 at 9:22 AM of Patient #3’s chart revealed Patient #3 was admitted to the dialysis clinic on 3/13/24 for acute kidney failure. Review of dialysis treatment sheets revealed the following elevated blood pressures (BP) post treatment: 5/01/24: BP 168/102 5/03/24: BP 162/112 5/06/24: BP 158/109 5/13/24: BP 160/100 5/17/24: BP 169/105 Further review of the treatment sheets revealed no documentation and/or interventions noted by the nurse. During an interview on 5/23/24 at 12:42 PM, Facility B Clinic Manager stated, “Some patients have orders in place for medications for elevated blood pressures but this patient doesn’t have any medications ordered nor do I see where the nurse notified the doctor”. Record review on 5/23/24 at 10:25 AM of Patient #4’s chart revealed Patient #4 was admitted to the dialysis clinic on 4/09/21 for end stage renal disease (ESRD). Review of the dialysis treatment sheets revealed the following elevated blood pressures post treatment: 5/01/24: BP 213/26 5/08/24: BP 159/138 5/10/24: BP 235/95 5/15/24: BP 217/90 5/17/24: BP 216/106 5/20/24: BP 200/84 Further review of the treatment sheets revealed no documentation and/or interventions noted by the nurse. During an interview on 5/23/24 at 1:09 PM, Facility B Clinic Manager stated, “This patient does not have any medications for elevated blood pressures nor do I see where the nurse notified the doctor”. Facility policy, entitled “Pre-Intra-Post Treatment Data Collection, Monitoring And Nursing Assessment” revealed, “Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record...Blood Pressure Post Treatment: If the patient can stand: Standing systolic BP greater than 140 mm/Hg (millimeters/mercury) or less than 90 mm/hg; Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg...Sitting BP for patient’s that cannot stand: Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg; Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg...”.”