Davita Windham Dialysis Center

“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: 44675 Based on observation, clinical record review, interview and review of facility policy, the facility failed to ensure the facility was maintained in a clean and sanitary environment. The finding included: 1. Observation conducted on 5/28/24 at 9:30 AM identified a dried brown/red substance on the wall next to the scale. Observation of the clean sink identified a dried brown substance under the sink and down onto the floor. 2. Observations conducted on 5/28/24 at 10:12 AM identified Staff Person #2 entered the lobby with patients waiting inside in full personal protective equipment (PPE; gown, gloves and goggles). Interview with the Clinical Manager on 5/28/24 at 1:30 PM identified PPE is not to be worn in the lobby. Review of the infection control for dialysis facilities policy directed that cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials. It further directed PPE is to be removed prior to leaving the treatment area and is not to be worn in non-treatment areas.”

“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: 44675 Based on observation, clinical record review and review of facility policy, the facility failed to clean and disinfect the hemodialysis station after hemodialysis treatment per facility policy. The finding included: a. Observation conducted on 5/28/24 at 9:40 AM identified Staff Person #2 was cleaning and disinfecting the hemodialysis station after a patient treatment. Staff Person #2 failed to clean and disinfect the drain lines from the hemodialysis machine to the wallbox and failed to clean and disinfect the wallbox. b. Observation conducted on 5/29/24 at 10:50 AM identified Staff Person #1 was cleaning and disinfecting hemodialysis station #4. Staff Person #1 failed to clean the counter behind the dialysis chair and utilized the same bleach rag to clean the back of the dialysis machine as the wall box. Review of the infection control for dialysis facilities policy directed at the end of each treatment, the dialysis station will be cleaned and disinfected. It directed the wall box, drain and watery supply lines are considered part of the dialysis delivery system. It further directed to disinfect all surfaces in touch with the patient or their belongings.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 47491 Based on observations during the discontinuation of hemodialysis treatment for two (2) of seven (7) patients (Patient #8 and Patient #9), the facility failed to maintain aseptic technique during care of thee Central Venous Catheter (CVC). The findings included: 1. Patient #8 had end stage renal disease, required hemodialysis three times weekly, and had a CVC in the upper right chest. Observation made on 5/29/24 at 9:23 AM identified Staff Person #1 discontinuing Patient #8’s dialysis treatment. After inserting heparin into the venous limb of his/her CVC, Staff Person #1 removed the 3 milliliter syringe and placed the uncovered, exposed venous limb onto the non-sterile treatment pad that was draped under Patient #8’s catheter. Staff Person #1 then removed the catheter cap from the package on Patient #8’s side table, lifted the venous limb off of the drape, and applied the cap to cover the exposed limb. 2. Patient #9 had end stage renal disease, required hemodialysis three times weekly, and had a Central Venous Catheter (CVC) in the upper right chest. Observation made on 5/29/24 at 9:25 AM identified Staff Person #1 discontinuing Patient #9’s dialysis treatment. After inserting heparin into the venous limb of his/her CVC, Staff Person #1 removed the 3 milliliter syringe and placed the uncovered, exposed venous limb onto the non-sterile treatment pad that was draped under Patient #9’s catheter. Staff Person #1 then removed the catheter cap from the package on Patient #9’s side table, lifted the venous limb off of the drape, and applied the cap to cover the exposed limb. Interview with Staff Person #1 on 5/29/24 at 10:54 AM identified he/she had placed the exposed end of the limb (hub) onto a non-sterile drape, and should not have exposed catheter limb to the non-sterile pad while getting the cap from the side table to cover the open end of the limb. Review of the Central Venous Catheter with ClearGuard Hemodialysis antimicrobial end caps procedure directs to not allow the hub of the catheter to touch non-sterile surfaces.”

“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: 47640 Based on a documentation review on 05/28/24 at 11:00 AM, 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: 1. On 05/28/24 at 11:00 AM the surveyor was not provided with documentation from the Bio Medical Technician or the Facility Administrator (FA). The following are violations: a. The facility failed to provide documentation to indicate that there was a sensitivity test completed within the past two years as required by Section 14.4.5.3.2 of NFPA 72 and section 9.6.1.3 of the 2012 edition of the “Life Safety Code” standard. b. The facility failed to provide documentation to indicate that corrosive sampling of sprinkler heads subjected to moist, and vapor dense areas has been completed, tested or replaced not in compliance with Section 5.3.1.1.2 of the 2011 Edition of NFPA 25. c. The facility failed to provide documentation to indicate that the fire department connections had been hydrostatically tested as required by table 5.1.1.2 of NFPA 25,” Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems”; i.e., there are records in sprinkler inspection reports of the fire department connection being hydrostatically tested. d. The facility failed to provide documentation to indicate that the 5th year obstruction test on the sprinkler system was completed as required by Table 5.1.1.2 of NFPA 25, 2011 Edition. i.e., There was no record of an obstruction test being completed in the sprinkler inspection reports. e. The facility failed to provide documentation to indicate that the emergency lights throughout the facility are being inspected monthly or tested annually, as required by Section 7.9 of the 2012 Edition of the “Life Safety Code.” i.e., there was no indication that a 90-minute drain down test was completed. f. The facility failed to maintain the sprinkler system in accordance with Section 5.1.1.2 of NFPA 25, “Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems”. i.e., there were two (2) gauges in the riser room that had a manufacturing date of 2018.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 44675 Based on a review of clinical records, interview, and policy review for two (2) of six (6) hemodialysis patients reviewed for prescription adherence, (Patient #2 and #3), the facility failed to ensure the patient’s hemodialysis treatment was delivered in accordance with the physician orders. The findings include the following: 1. Patient #3 had diagnoses that included end stage renal disease. Patient #3’s physician orders included hemodialysis treatment three times a week for three hours and thirty minutes with a left upper arteriovenous fistula (AVF) with 16 gauge needles, 2.0 K 2.5 Ca dialysate, 350 Blood Flow Rate (BFR), 800 Dialysate Flow Rate (DFR) and an Estimated Dry Weight (EDW) of 79 kilograms. Review of Patient #3’s treatment flowsheets identified the following: a. On 5/11/24 Patient #3’s BFR at the beginning of treatment was 400 with no rationale as to why the treatment was exceeding the prescribed BFR of 350. Patient #3’s BFR decreased to 275 due to high venous pressures. Patient #3’s arterial pressures (indicates the ease or difficulty which blood is flowing) ranged from -122 to -249. b. On 5/23/24 Patient #3 had multiple cannulations (3 or more needles). Patient #3’s BFR during treatment was 400 with no rationale as to why the treatment was exceeding the prescribed BFR of 350. Patient #3’s arterial pressures ranged from -170 to -207. c. On 5/25/24 Patient #3’s BFR during treatment was 300 with no rationale as to why the treatment was not meeting the prescribed BFR of 350. d. On 5/28/24 Patient #3’s BFR during treatment was 400 with no rationale as to why the treatment was exceeding the prescribed BFR of 350. Patient #3’s arterial pressures ranged from -184 to -238. Review of the arterial blood flow protocol directed for a needle gauge of 16 the suggested blow flow range is 250 - 350 and the pre pump arterial pressure limit should be no more negative than -200. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed that if the dialysis prescription is not being met (including dialysis flow rate or change/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 47491 Based on a review of clinical records, interview, and policy review for three (3) of six (6) hemodialysis patients reviewed for blood pressure (Patient #2, #3 and #5), the facility failed to ensure the patient had a standing blood pressure and pulse post hemodialysis treatment and addressed a significant change in blood pressure during and at the end of hemodialysis treatment with the licensed nurse. The findings include the following: 1. Patient #2 was admitted to the facility with diagnoses that included end stage renal disease. Patient #2’s physician ordered included hemodialysis treatment three times weekly for three hours with an upper left arm arteriovenous fistula (AVF) with 16 gauge needles, 3.0K 2.5Ca dialysate, 350 blood flow rate (BFR), 600 dialysate flow rate (DFR) and an estimated dry weight of 51 kilograms. Review of Patient #2’s hemodialysis flowsheets identified the following: a. On 5/3/24, Patient #2 had a post treatment blood pressure of 185/92 without documentation a registered nurse was informed or assessed the patient prior to leaving the clinic. b. On 5/6/24, Patient #2 had a post treatment blood pressure of 184/95 without documentation a registered nurse was informed or assessed the patient prior to leaving the clinic. c. On 5/13/24, Patient #2 had a post treatment blood pressure of 211/36 without documentation a registered nurse was informed or assessed the patient prior to leaving the clinic. d. On 5/15/24, Patient #2 had a post treatment blood pressure of 187/86 without documentation a registered nurse was informed or assessed the patient prior to leaving the clinic. e. On 5/18/24, Patient #2 had a post treatment blood pressure of 200/92 without documentation a registered nurse was informed or assessed the patient prior to leaving the clinic. f. On 5/9/24, Patient #2 had intradialytic blood pressures of 88/48, 70/45, 68/42, and 88/49 without documentation a registered nurse was informed or had evaluated the patient. 2. Patient #3 was admitted to the facility with diagnoses that included end stage renal disease. Patient #3’s physician orders included hemodialysis treatment three times a week for three hours and thirty minutes with a left upper arteriovenous fistula (AVF) with 16 gauge needles, 2.0 K 2.5 Ca dialysate, 350 blood flow rate (BFR), 800 dialysate flow rate (DFR) and an estimated dry weight (EDW) of 79 kg. Review of annual plan of care dated 8/31/23 identified Patient #3 was stable. Patient #3’s fluid/blood pressure plan of care identified interventions to maintain Patient #3’s post weight compared to target weight and blood pressures were within range. Review of Patient #3’s hemodialysis flowsheets identified the following: a. On 5/11/24 Patient #3’s blood pressure at 7:01 AM was 105/57. At 7:31 AM Patient #3’s blood pressure decreased to 71/37 (34 point decrease systolic). The PCT (patient care technician) retook Patient #3’s blood pressure at 7:33 AM which resulted at 78/45. At 7:37 AM Patient #3’s blood pressure was 88/47 and the PCT turned off the Ultra Filtration Rate (UFR) (controls the fluid removal). The flowsheet failed to identify if the licensed nurse was notified of Patient #3’s decrease in blood pressure and interventions if any, to be delegated to the PCT. 3. Patient #5 was admitted to the facility with diagnoses that included end stage renal disease. Patient #5’s physician orders included hemodialysis treatment three times a week for two hours and forty five minutes, 3.0 K 2.5 Ca dialysate and an estimated dry weight (EDW) of 58 kg. Review of annual plan of care dated 1/23/24 identified Patient #5 was stable. Patient #5’s fluid/blood pressure plan of care identified interventions to maintain Patient #5’s post weight compared to target weight and blood pressures were within range. Review of Patient #5’s hemodialysis flowsheets identified the following: a. On 4/26/24 Patient #5 ambulated with a walker and did not have a standing blood pressure post treatment and/or the reason why a standing blood pressure was not obtained documented. b. On 4/29/24 Patient #5 ambulated with a walker and did not have a standing blood pressure post treatment and/or the reason why a standing blood pressure was not obtained documented. c. On 5/1/24 Patient #5 ambulated with a walker and did not have a standing blood pressure post treatment and/or the reason why a standing blood pressure was not obtained documented. d. On 5/3/24 Patient #5 ambulated with a walker and did not have a standing blood pressure post treatment and/or the reason why a standing blood pressure was not obtained documented. e. On 5/6/24 Patient #5 ambulated with a walker and did not have a standing blood pressure post treatment and/or the reason why a standing blood pressure was not obtained documented. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed that abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “abnormal findings” section in this policy). The policy directed an abnormal blood pressure finding would be a systolic less than 90mm/HG. It further directed if a patient is not able to stand, document the reason and sitting BP. The policy directed an intradialytic systolic blood pressure of less than 90 mm/HG, an intradialytic diastolic blood pressure less than 50 mm/HG, a post treatment sitting systolic blood pressure of greater than 140 mm/HG, a post treatment sitting diastolic blood pressure of greater than 90 mm/HG or less than 50 mm/HG be reported to the licensed nurse and documented in the patient’s medical 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: 44675 Based on clinical record review, interview, and review of facility policy for three (3) of six (6) Patients, (Patient #1 #2, and #6), reviewed for tuberculosis testing, the facility failed to complete appropriate tuberculosis testing per facility policy. The finding included: 1. Patient #2 was admitted to the facility on 12/6/2023 with diagnoses that included end stage renal disease. Patient #2’s physician orders included hemodialysis three times a week for three hours utilizing 16 gauge needles, 3.0K 2.5 Ca dialysate, a blood flow rate of 350 milliliters per minute, a dialysate flow rate at 600 milliliters per minute, and an estimated dry weight of 51.0 kilograms.. Review of Patient #2’s Vaccination Surveillance Report failed to identify the patient was screened for tuberculosis upon admission to the facility and then again within twenty-one days thereafter, however a chest x-ray dated 12/18/23 was documented and indicated Patient #2’s lungs were clear. Further review of the Vaccination Surveillance Report identified Patient #2 was administered his/her first Tuberuculin Skin Test (TST) on 4/10/24 (which resulted negative on 4/13/24), but subsequent TST’s administered on 4/26/24 and 5/6/24 were not evaluated due to the patient’s absence from the facility). 2. Patient #6 was admitted to the facility 12/15/23 with diagnoses that included end stage renal disease. Patient #6’s physician’s orders included hemodialysis three times a week for three hours and fifteen minutes utilizing 15 gauge needles, 2.0K 2.5 Ca dialysate, a blood flow rate of 450 milliliters per minute, a dialysate flow rate of 600 milliliters per minute, and an estimated dry weight of 80.2 kilograms.. a. Review of Patient #6’s Vaccination Surveillance Report identified the initial TST was administered on 12/29/23 (and resulted as negative on 12/31/23), however a second TST was not administered until 4/12/24 (three months and fourteen days after the first). Interview with the Clinical Coordinator on 5/29/24 at 8:20 AM indicated he/she had recently taken over managing patient vaccinations and screenings in April 2024, and had identified Patient #2 and Patient #6 did not have their TST’s completed per facility policy, which directed to administer a TST shortly after admission to the facility, and a second TST within three weeks of the first TST. The Clinical Coordinator further indicated the previous Vaccination/Screening Manager had interpreted the tuberculosis infection control policy erroneously and accepted the “clear” chest x-ray dated 12/18/23 as satisfying the TST requirement for Patient #2, whereas both TST’s would have needed to be administered regardless of the chest x-ray result. Review of the Tuberculosis Infection Control policy directed to administer two TST’s upon admission to the facility, the first as soon as possible and the second one to three weeks after the first. b. Further review of Patient #6’s Vaccination Surveillance Report identified the TST administered on 4/12/24 resulted positive on 4/15/24 (a 10.0 millimeter hardened area where the TST was placed) prompting an order for a chest x-ray (completed on 4/18/24 and found no evidence of tuberculosis). However, the facility failed to provide the Tuberculosis Risk Appraisal Questionnaire (TB-RAQ)(assesses symtpoms of a TB infection) associated with the 4/12/24 TST. Interview with the Clinical Coordinator on 5/29/24 at 8:29 AM identified a Tuberculosis Risk Appraisal Questionnaire (TB-RAQ) was completed, however was unable to locate it in Patient #6’s chart. Interview with the Medical Director on 5/28/24 at 3:15 PM identified he/she was aware of Patient # 6’s positive TST result on 4/15/24, that Patient #6 was asymptomatic, and authorized the facility to continue administering Patient #6’s dialysis treatments. The Medical Director further indicated he/she was puzzled by the negative result on 12/31/23, that Patient #6 grew up in India, may have had the bacille Calmette-Guerin vaccine (the vaccine given for tuberculosis in many foreign countries), and had ordered a chest x-ray. Review of the Tuberculosis Infection Control policy directed completion of a TB-RAQ with a positive TST, IGRA history, and with annual tuberculosis surveillance. 3. Patient #1 was admitted to the facility on 2/20/24 with diagnoses that included end stage renal disease. Patient #1’s physician orders included hemodialysis treatment three times a week for three hours and thirty minutes, 2.0 K 2.5 Ca dialysate and an estimated dry weight (EDW) of 94 kg. Review of Patient #1’s vaccination history identified Patient #1 had a chest x-ray conducted on 2/12/24 (prior to the first treatment in the facility). Patient #1 had a tuberculosis risk appraisal questionnaire (TB-RAQ) completed on 4/13/24 with no symptoms identified. Patient #1 had a Tubersol test administered on 4/13/24 with the result of 0 mm and a second Tubersol test administered on 4/30/24 with the result of 0 mm (approximately two months after the first treatment date). Patient #1 failed to have a TB-RAQ and two step Tubersol tests completed upon admission to the facility. Interview with the CN on 5/29/24 at 10:42 AM identified she took over managing vaccines in April of 2024 and reviewed all the patient’s vaccination histories. She identified the staff member who was managing the vaccines previously thought if a new admission had a chest x-ray, they would not need a two step Tubersol test completed. She identified she entered Tubersol tests for patients that had them missing. She further identified Patient #1 should have had a two step Tubersol test completed upon admission to the facility. Review of the tuberculosis infection control policy directed for a new admission to dialysis with a chest x-ray prior to the first treatment, upon admission a TB-RAQ should be completed and administer a one step TST followed by a second TST one to three weeks after the admission TST.”