Fmc Dialysis Services of Blackstone Valley

“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: 44223 Based on observation, interview, and policy review, the facility staff failed to ensure Personal Protective Equipment (PPE) worn into the dialysis station had been cleaned and disinfected prior to entering the dialysis station. Findings Include: Review of the facility policy, titled Personal Protective Equipment, published 11/6/23, included the following: Purpose: The purpose of this policy is to identify Personal Protective Equipment (PPE) and potential areas for use. Policy: Personal protective equipment including a full-face shield or mask and protective eyewear with full side shield, fluid-resistant gowns, and gloves, must be worn to protect employees from blood or other potentially infectious material (OPIM). PPE is used to protect employees who are occupationally exposed to blood or OPIM when performing procedures during which spurting or splattering of blood might occur. On 10/8/24 at 12:00 P.M., during an observation of the treatment area, the surveyor observed the Clinical Manager (CM) pull a face shield out of a drawer at the front of the nursing station and put it on prior to entering a treatment station to care for a patient. During further observation the surveyor observed 6 face shields stacked on top of each other in the drawer, causing concern for potential cross contamination. During an interview on 10/9/24 at 2:45 P.M. the CM said she was unable to say whether or not the face shields had been cleaned and that there is no process in place to ensure they are cleaned prior to going in the drawer.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 38141 Based on interview, record review, and policy review, the facility failed to ensure staff documented the theoretical conductivity (TCD), which is the expected conductivity of the dialysate calculated by the machine based on the dialysate composition, sodium, and bicarbonate setting, prior to initiating treatment for 3 of 7 patients records (#1,#2,#6) reviewed out of a total sample of 10 patients. Findings Include: Review of the facility policy, titled Checking Conductivity and pH of Final Dialysate, published 5/6/24, included the following: Purpose: The purpose of this policy is to provide guidance to verify final dialysate conductivity and pH prior to initiating hemodialysis treatments and during treatments if required. The theoretical conductivity (TCD) is calculated by the machine based on the concentrate formula selected, and the sodium and bicarbonate values entered in the dialysate composition screen. To ensure delivery of safe dialysate, the conductivity alarm limits must be maintained at +/- 0.5 mS/cm of the TCD. Check TCD on all dialysis machines. Ensure alarm limits are +/- 0.5 mS/cm of the TCD of the dialysate concentrate ordered by the attending physician. Staff/care partners must maintain limits at +/-0.5 mS/cm of the TCD. If limits are found not to be set appropriately, staff should adjust them to +/- 0.5 mS/cm of the TCD. Staff/care partners May Not Adjust them to any other position than +/- 0.5 mS/cm of the TCD. Documentation: Record conductivity and pH readings in the facility treatment record. 1.) For Patient #2, the facility failed to ensure that staff documented the TCD in the treatment record. Patient #2 was admitted to the facility in December 2023 with a diagnosis of End Stage Renal Disease requiring dialysis. Review of 9 treatment sheets, dated 9/17/24 through 10/5/24, indicated that staff failed to document the TCD for 3 of 9 treatments including 9/28/24, 10/1/24 and 10/5/24. 2.) For Patient #6, the facility failed to ensure that staff documented the TCD in the treatment record. Patient #6 was admitted to the facility in March 2024 with a diagnosis of End Stage Renal Disease requiring dialysis. Review of 9 treatment sheets, dated 9/18/24 through 10/7/24, indicated that staff failed to document the TCD for 7 of 9 treatments including 9/18/24, 9/23/24, 9/25/24, 9/30/24, 10/2/24, 10/4/24 and 10/7/24. During an interview on 10/9/24 at 2:40 P.M., the Clinical Manager (CM) said the TCD should be documented on the treatment sheet. 44223 3.) For Patient #1 the facility failed to ensure that staff documented the TCD in the treatment record. Patient #1 was admitted to the facility in July 2024 with a diagnosis of End Stage Renal Disease requiring hemodialysis three times a week. Review of 9 treatment sheets, dated 9/18/24-10/7/24, indicated the staff failed to document the TCD for 4 of 9 treatments, including 9/23/24, 9/25/24, 10/2/4, and 10/7/24. During an interview on 10/9/24 at 2:40 P.M. the CM said the TCD should be documented on the treatment sheets.”

“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: 38141 Based on observation, interview and record review, the facility failed to deliver the prescribed dialysate for 1 of 4 applicable patients (#8) in a total of 10 sampled patients. Findings include: A dialysate bath is made up of bicarbonate, treated water and acid concentrate. The acid concentrate contains specific concentrations of potassium (K), calcium (Ca), sodium, magnesium and other electrolytes as well as glucose. Potassium plays a key role in smooth muscle contraction, especially within the heart. Potassium concentration is significant as an alteration in serum potassium concentration can result in irregular heart rhythms. The normal value range for serum potassium is 3.6-5.0 mEq/L. Review of the physician’s dialysis bath prescription orders for Patient #8, dated 9/21/24, indicated the following: Dialyzer: Optiflux 200NRe and the dialysate bath contained Potassium 2K, calcium 2.25 and bicarb 35. On 10/8/24 at 8:55 A.M., during treatment floor observation, the surveyor reviewed the dialysis prescription for Patient #8 with the Charge Nurse (CN). Upon observation of the dialysis machine, the patient was receiving potassium 3K, not 2K as ordered. During an interview on 10/8/24 at 9:05 A.M., the CN said that the order was for 2K, and she was not sure why Patient #8 was receiving 3K instead of 2K as ordered. The CN told the surveyor that she switched it back to 2K as ordered and that she will notify the physician.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 44223 Based on observation, staff interview, and policy review, the facility failed to ensure that a vascular access site was monitored while a pressure clamp was being utilized to prevent access failure and/or stenosis for 1 of 2 applicable patients (#10), from a total sample of 10 patients. Findings Include: Purpose: The purpose of this procedure is to provide guidance for when pressure clamps may be used on fistula or graft cannulation sites for hemostasis post treatment. Recommendations: Keep clamp use to a minimum. Patient and/or family members should be instructed to hold sites whenever possible. Policy: * A doctor’s order is required for clamp usage. *Use only one clamp at a time to prevent excessive pressure which can cause thrombosis. While the clamp remains on the access, check for thrill every 10 minutes. Do not leave clamps in place longer than 20 minutes per clamp. *Patient care staff must monitor clamp placement carefully while in use as clamp may slip and result in blood loss. Patient #10 was admitted to the facility in August 2014 with a diagnosis of End Stage Renal Disease requiring hemodialysis three times a week. Review of the medical record indicated the patient did not have a physician order for the use of a pressure clamp. On 10/8/24 at 9:50 A.M., the surveyor observed Registered Nurse (RN) #3 discontinue dialysis treatment for Patient #10, who had an arteriovenous (AV) fistula on his/her right arm. RN #3 was observed to have removed the needle from the upper access, applied gauze and tape, then Patient #10, with a gloved hand, applied pressure to the site. At 9:55 A.M., RN #3 removed the needle from the lower access, applied gauze and tape, then applied a pressure clamp. RN #3 then left station #6, while Patient #10 continued to apply pressure on the upper access, and the clamp remained on the lower access. At 10:22 A.M., the Charge Nurse was observed entering station #6 and removed the clamp from the lower access. RN #3 failed to assess the clamped site after 10 minutes per the facility policy, and left the clamp on Patient #10’s lower access for a total of 27 minutes, exceeding the 20 minutes per facility policy. During an interview on 10/9/24 at 12:08 P.M., the Clinical Manager (CM) said Patient #10 did not have an order for a clamp. She also said the site should of been checked after 10 minutes and then removed after 20 minutes.”

“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: 44223 Based on staff interview and policy review, the Medical Director failed to ensure that staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after administration of heparin (blood thinning medication) bolus to initiate dialysis treatment for 3 of 7 applicable patients (#1,#3,#5) out of a total sample of 10 patients. Findings Include: Review of the facility policy, titled Heparin Bolus Administration, published 11/1/21, included the following: *Allow heparin to circulate within the bloodstream for a minimum of 3-5 minutes before initiating treatment to prevent blood from clotting in the dialysis circuit. 1.) For Patient #1, the Medical Director failed to ensure the staff adhered to the heparin administration policy and waited 3-5 minutes after administration to initiate treatment. Review of the medical record indicated Patient #1 had a physician’s order to administer heparin bolus 2000 units intravenously (IV) every dialysis treatment. Review of 9 treatment sheets, dated 9/18/24-10/7/24, indicated for 6 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment, including the following: *On 9/20/24 treatment started at 10:44 A.M., heparin was documented as administered at 10:48 A.M., 4 minutes after the initiation of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. *On 9/23/24 treatment started at 10:30 A.M., heparin was documented as administered at 11:01 A.M., 31 minutes after the initiation of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. *On 9/25/24 treatment started at 10:24 A.M., heparin was documented as administered at 10:22 A.M., 2 minutes prior to the initiation of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. *On 9/27/24 treatment started at 10:41 A.M., heparin was documented as administered at 10:43 A.M., 2 minutes after the initiation of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. *On 9/30/24 treatment started at 10:30 A.M., heparin was documented as administered at 10:31 A.M., 1 minute after initiation of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. *On 10/4/24 treatment started at 10:30 A.M., heparin was documented as administered at 10:31 A.M., 1 minute after the initiation of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. 2.) For Patient #3, the Medical Director failed to ensure the staff adhered to the heparin administration policy and waited 3-5 minutes after the administration to initiate treatment. Review of the medical record indicated Patient #3 had a physician’s order to administer heparin bolus 2000 units IV every dialysis treatment. Review of 9 treatment sheets, dated 9/20/24-10/7/24, indicated for 4 of 9 treatments, staff failed to wait the 3-5 minutes after administration of heparin to initiate treatment, including the following: *On 9/27/24 treatment started at 6:36 A.M., heparin was documented as administered at 7:06 A.M., 30 minutes after the initiation of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. *On 9/30/24 treatment started at 6:54 A.M., heparin was documented as administered at 6:53 A.M., 1 minute prior to the initiation of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. *On 10/2/24 treatment started at 6:55 A.M., heparin was documented as administered at 6:54 A.M., 1 minute prior to the initiation of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. *On 10/5/24 treatment started at 6:27 A.M., heparin was documented as administered at 6:29 A.M., 2 minutes after the initiation of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. 3.) For Patient #5, the Medical Director failed to ensure the staff adhered to the heparin administration policy and waited 3-5 minutes after the administration to initiate treatment. Review of the medical record indicated Patient #5 had a physician’s order to administer heparin bolus 2000 units IV every dialysis treatment. Review of 9 treatment sheets, dated 9/13/24-10/4/24, indicated for 5 of 9 treatments, staff failed to wait the 3-5 minutes after administration of heparin to initiate treatment, including the following: *On 9/13/24 treatment started at 9:28 A.M., heparin was documented as administered at 9:28 A.M., 0 minutes prior to the initiation of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. *On 9/16/24 treatment started at 9:31 A.M., heparin was documented as administered at 9:46 A.M., 15 minutes after the initiation of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. *On 9/20/24 treatment started at 9:16 A.M., heparin was documented as administered at 9:14 A.M., 2 minutes prior to the initiation of the treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. *On 9/25/24 treatment started at 9:15 A.M., heparin was documented as administered at 9:15 A.M., 0 minutes prior to the initiating of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. *On 9/27/24 treatment started at 9:15 A.M., heparin was documented as administered at 9:17 A.M., 2 minutes after the initiation of treatment, not the 3-5 minutes prior to initiation of dialysis per the facility policy. During an interview on 10/9/24 at 2:40 P.M., the Clinical Manager said that heparin should be given 3-5 minutes before the initiation of dialysis.”