Davita Trumbull Dialysis

“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: 44675 Based on observations, facility documentation and interviews, the facility failed to appropriately clean and disinfect the dialysis station after a hemodialysis treatment. The findings included: Observations conducted on 10/9/24 at 12:04 PM identified during disinfection of the hemodialysis station after a patient treatment, Staff Person #1 failed to disinfect the top of the IV pole, clipboard and stethoscope hanging from the IV pole. Review of the infection control for dialysis facilities policy identified surfaces to disinfect include but are not limited to all surfaces in contact with the patient or their belongings and frequently contacted by healthcare personnel. It further directed the wall box, drain, and water supply lines are considered part of the dialysis delivery system and should be clean with 1:100 bleach as part of the routine station disinfection between each patient treatment. It further identified non-disposable items are to be disinfected after each patient use.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 47491 Based on review of clinical records, interview and facility policy for one (1) of five (5) patients reviewed for vaccinations (Patient #9), the facility failed to monitor Hepatitis B surface antigen levels for a Hepatitis susceptible patient. The findings included: 1) Patient #9 had end stage renal disease, required daily peritoneal dialysis treatments, and had an abdominal catheter in the upper left quadrant. Review of Patient #9’s lab work dated 3/1/24 identified a Hepatitis B antibody result of 4 (indicative that the patient is not immune to the Hepatitis B virus) Review of Patient #9’s lab work from April 2024 through September 2024 failed to identify monthly testing for the Hepatitis B surface antigen level. Interview with Staff Person #1 on 10/9/24 at 10:10 AM identified Patient #9 had refused a Hepatitis B Booster when his/her antibody level had dropped below 10 in March 2024 and that monthly surface antigen levels should have been drawn as Patient #9 was susceptible to Hepatitis B. 2)Patient #7 was admitted to the facility with diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three (3) times weekly for four (4) hours with a left upper arteriovenous fistula (AVF), 15-gauge needles and a target weight of 69 kilograms. Review of Patient #7’s hepatitis B antibodies dated 10/24/22 identified Patient #7’s antibodies were three (3) (susceptible to hepatitis B). Review of Patient #7’s hepatitis B antigens (indicates a hepatitis B infection) dated 10/24/23 identified Patient #7’s antigens were negative. Patient #7 failed to have a hepatitis B antigen draw for the month of November and December 2022 per facility policy. Review of the Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance policy directed monthly Hepatitis B antigen testing for patients with an antibody level that was less than 10.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 44675 Based on a review of clinical records, interview, and policy review for one (2) of six (6) hemodialysis patients reviewed for Hepatitis B (Patient #7 and #11), the facility failed to ensure the hepatitis B (liver infection transmitted through blood) vaccination booster was offered and administered timely when the patient became susceptible to hepatitis B in accordance with facility policy. The findings include the following: 1) Patient #7 was admitted to the facility with diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three (3) times weekly for four (4) hours with a left upper arteriovenous fistula (AVF), 15-gauge needles and a target weight of 69 kilograms. Review of Patient #7’s hepatitis vaccinations identified Patient #7 received a booster on 1/23/23 (three months after Patient #7 was identified as susceptible to the hepatitis B virus). Review of Patient #7’s hepatitis vaccinations identified Patient #7 received a booster on 6/24/24 (eight months after Patient #7 was identified as susceptible to the hepatitis B virus). Interview with the Clinical Services Specialist on 10/8/24 at 11:24 PM identified a booster is given annually if the patients hepatitis B antibodies are less than ten (10). She identified the booster should be administered as soon as the patient is identified as susceptible to the hepatitis B virus. 2) Patient # 11 had diagnoses of end stage renal disease, required daily peritoneal dialysis treatments and had an abdominal catheter in the upper left quadrant. Review of a vaccination report for Patient #11 had consented to receive the Hepatitis B vaccine and was administered the first three (3) doses on 12/19/23, 1/18/24, and 2/22/24. The fourth dose, however, was not administered or yet scheduled to be administered. Interview with Staff Person #2 on 10/9/24 at 11:50 AM identified the Hepatitis B vaccination series should be scheduled at 0, 1, 2, and 6 months and that he/she forgot to administer (had missed) the fourth dose which was due in June 2024. Review of the hepatitis B surveillance, vaccination, infection control measures and isolation guidance policy directed for an antibody less than ten (10) and core negative, the patient is susceptible to hepatitis B and should be have a hepatitis B antigen tested monthly. It directed on annual retesting of immune patients due to vaccination, hepatitis B antibodies less than ten, with nephrologist order, should be administered a booster dose of the vaccine. Retest the hepatitis B antibodies one to two months after the booster dose and if the antibody is greater than ten, continue to retest annually. It identified there is not limited to the number of annual boosters although further doses should be discontinued if ay any time, the patient fails to respond with a hepatitis B antibody greater than or equal to ten. It further directed that results will be reviewed promptly to verify that patients are managed appropriately based on their testing results. 47491 Based on clinical record review, facility documentation, and interview for one (1) of five (5) patients reviewed for vaccinations, (Patient #11), the facility failed to ensure that a Hepatitis Vaccination was administered in accordance with facility policy. The findings included: Patient # 11 had diagnoses of end stage renal disease, required daily peritoneal dialysis treatments and had an abdominal catheter in the upper left quadrant. Review of a vaccination report for Patient #11 had consented to receive the Hepatitis B vaccine and was administered the first three (3) doses on 12/19/23, 1/18/24, and 2/22/24. The fourth dose, however, was not administered or yet scheduled to be administered. Interview with Staff Person #2 on 10/9/24 at 11:50 AM identified the Hepatitis B vaccination series should be scheduled at 0, 1, 2, and 6 months and that he/she forgot to administer (had missed) the fourth dose which was due in June 2024. Review of the Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance policy directs ... (need the specific Policy).”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 32738 Based on observation and interview the facility failed to enusre that the brine tank was filled to the proper level The fndings included: On 10/08/24 at approx. 10:30 and during document review, The brine solution tank was not filled to the proper level, the level was approx. 1/3 full, negating its ability to function properly.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 32738 On 10/08/24 at approx. 09:30 and during document review, the facility failed to maintain a building that was constructed and maintained to ensure the safety of the patients, the staff and the public. The findings include the following: Documentation was not provided to indicate that the sprinkler system was being maintained per NFPA 25, 5.1.1.2. Ie. No documentation was provided for first quarter of 2024.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 44675 Based on interview and review of facility policy for two (2) of ten (10) Patients (Patient #4 and #11) the facility failed to obtain an acceptable chest x-ray prior to admission to the facility and complete a two-step PPD test per facility policy. The finding included: 1. Patient #4 was admitted to the facility on 8/14/24 with diagnoses that included end stage renal disease. Review of the physician’s orders directed home hemodialysis four times a week for two(2) hours and fifty (50) minutes with a right central venous catheter (CVC). Hospital chest x-ray dated 7/30/24 (prior to admission to the facility) identified Resident #4 had low lung volumes with pulmonary vascular congestion, no definite plural effusions and no pneumothorax. However, the chest x-ray did not state Resident #4’s lungs were clear, negative, normal or unremarkable per facility policy. Review of Patient #4’s Tuberculin purified protein derivative (PPD is a type of test which helps diagnose a tuberculosis infection) results identified Patient #4 had a PPD placed on 8/14/24 and read on 8/15/24 as 0 mm (negative result). The medical record failed to identify a second PPD test was administered and read within twenty-eight (28) days per facility policy. Interview with Home Hemodialysis RN on 10/7/24 at 11:00 AM identified she did not complete a two step PPD test for Patient #4 and identified she was not sure if Patient #4 should have had a two step PPD test conducted. Interview with the Clinical Services Specialist on 10/7/24 at 1:10 PM identified Patient #4 should have had a second PPD test completed. 2. Patient #11 was admitted to the facility on 10/31/23 had diagnoses which included end stage renal disease, a physician’s order for peritoneal dialysis treatments for nine (9) hours daily, utilizing an abdominal catheter in the upper left abdomen and varied strengths of dialysate solution. Review of Patient #11’s Vaccination and Surveillance Report identified the following: a. A TST (Tuberculin Skin Test) was administered on 11/7/23. b. A TB RAQ (Tuberculosis Risk Assessment) was completed on 11/7/23 Interview with Staff Person #2 on 10/9/24 identified the facility failed to administer the second TST in accordance with facility policy. Staff Person #2 further indicated the second TST should have been administered within twenty-eight days of the first TST. Review of the tuberculosis infection control policy directed a chest x-ray that has been interpreted by a radiologist as clear, negative, normal or unremarkable is acceptable. It further directed for an admission new to dialysis with a chest x-ray completed within three months prior to the first treatment, administer a two step TST (tuberculin skin test) on admission (initial TST with a second TST repeated one to three weeks after the first). 47491”

“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: 47491 Based on clinical record review, facility documentation, and interview for three (3) of five (5) patients reviewed for peritoneal dialysis, (Patient #8. #9 and #11), the facility failed to ensure patients used the appropriate dialysate concentrations with treatments. The findings included: 1. Patient #8 had diagnoses that included end stage renal disease. A physician’s order dated 4/30/23 directed daily treatments of five (5), 2,000 milliliter exchanges using varied dialysate concentrations over a nine (9) hour and forty (40) minute timeframe, with a last fill of 1600 milliliters of Extraneal (7.5% dialysate) over a fourteen (14) hour timeframe, using a mid-abdominal peritoneal dialysis catheter. Review of Patient #8’s daily treatment records dated 7/1/24 through 9/23/24 identified the patient was compliant with dialysis treatments, however failed to identify the patient had followed specific fluid use guidelines related to dialysate use with each treatment. 2. Patient #9 had diagnoses that included end stage renal disease. A physician’s order dated 7/11/24 directed daily treatments of three (3) 2,000 milliliter exchanges using varied dialysate concentrations over an eight (8) hour timeframe and a last fill of 1500ml using varied dialysate concentrations over a seven (7) hour timeframe, using an upper abdominal peritoneal dialysis catheter. Review of Patient #9’s daily treatment records dated 7/11/24 through 10/6/24 identified the patient was compliant in completing most dialysis treatments, however failed to identify the patient had followed specific fluid use guidelines related to dialysate use with each treatment. 3. Patient #11 had diagnoses that included end stage renal disease. A physician’s order dated 12/19/23 directed daily treatments of five (5) 1,500 milliliter exchanges using varied dialysate concentrations over a nine (9) hour timeframe, using an upper abdominal peritoneal dialysis catheter. A physician’s order dated 9/26/24 changed the daily treatments to four (4) 1500ml exchanges using varied concentrations. Review of Patient #11’s daily treatment records dated 6/5/24 to 10/8/24 identified the patient was compliant with dialysis treatments, however failed to identify the patient had followed specific fluid use guidelines related to dialysate used with each treatment. Interview with Staff Person #1 on 10/9/24 at 1:30 PM identified he/she had provided fluid guidelines to Patient #8 and #9, however could not provide a copy of the fluid guideline document to verify dialysate usage with treatments. Staff Person #1 further identified that although he/she was verifying treatments were completed monthly for Patient #8, he/she did not verify the patients were following dialysate use guidelines for each treatment. Staff Person #1 identified he/she did not review Patient #9’s treatment records since July 1, 2024 as the skilled nursing facility (where Patient #9 resides) had forgotten to send the data card (which captures data for each treatment performed) with the patient during clinic visits. Staff Person #1 further indicated on 10/8/24 at 9:48 AM that patient treatments should be reviewed monthly during clinic visit. Staff Person #1 had gone to the skilled nursing facility on 10/8/24 to retrieve the data card in order to download the treatments. Interview with Staff Person #2 on 10/10/24 at 11:50AM identified the Patient #11 was compliant with dialysis treatments, however failed to identify the patient had followed specific fluid guidelines related to the dialysate concentration used with each treatment. Furthermore, Staff Person #2 failed to provide a copy of the fluid guideline documents to verify dialysate concentrations usage with treatments and identified he/she did not provide Patient #11 with dialysate use guidelines. Review of the Home Training Agreement and Training Release policy directs adherence to prescribed treatments, the expectation to dialyze as prescribed by the physician, and to bring treatment records to each clinic visit.”

“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: 44675 Based on observation, interview and review of facility policy for five (5) Patients (Patient #3, #12, #13, #14 and #15) the facility failed to ensure pre-drawn medications were appropriately labeled in accordance with facility policy. The finding included: During the flash tour of the facility treatment floor on 10/7/24 at 9:30 AM the following medications dated 10/7/24 were drawn for second shift patients without the time drawn labeled on the syringes: a. Patient #3’s 1000 units of heparin bolus and 700 units/hr heparin maintenance. b. Patient #12’s 2000 units of heparin bolus and 500 unit/hr heparin maintenance. c. Patient #13’s 2000 units of heparin bolus and 500 units/hr heparin maintenance. d. Patient #14’s 4000 units of heparin bolus and 1000 units/hr heparin maintenance. e. Patient #15’s 2000 units of heparin bolus and 500 units/hr heparin maintenance. Review of the anticoagulation policy directed heparin syringes are to be labeled with the patient’s name, medication name and dosage route date and time prepared and initials of the teammate preparing the medication.”