Fmc Services of Stoneham

“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: 44223 Based on observation, staff interview, and policy review, the facility failed to 1.) ensure 1 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #7) observed, adequately disinfected contaminated surfaces, medical devices, and equipment within the dialysis station, increasing the risk of cross contamination with blood borne pathogens; 2.) ensure that 1 of 2 staff members (Registered Nurse [RN] #2) did not dispose of prime waste into the dialysis station wall box; and 3.) ensure 7 of 24 blood pressure (BP) cuffs observed were free from lint and debris to allow for proper disinfection. Findings Include: Review of the facility policy, entitled Cleaning and Disinfecting the Dialysis Station, published 9/5/23, indicated the following: Definition: Dialysis Station *Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment, patient training, and/or patient clinic visits. Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine/cycler and attachments such as IV pole, BP cuff and hand sanitizer/holder, organizer, chair/bed, Pureflow SL, individual television and remote. Cleaning of the Dialysis Wall Box * Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately if splattered with blood. All surfaces shall be disinfected with 1:100 bleach solution. Special attention should be given to build up and/or cleaning splatter and spray of concentrate solution. Review of the facility policy, entitled Use of Priming Buckets, published 5/6/24, included the following: * At the completion of the patient treatment, remove the priming bucket or approved removable container, and dispose of the Normal Saline in the utility room hopper or dirty sink. 1. The facility failed to ensure that CCHT #7 adequately cleaned and disinfected the station for the next patient. On 1/21/25 at 9:20 A.M., the surveyor observed CCHT #7 disinfect station 12 for the next patient. She was observed to disinfect the hemodialysis machine and the hemodialysis chair using 1:100 bleached soaked pads. CCHT #7 failed to disinfect underneath the tray tables on both sides of the chair, the prime waste bucket, counter tops, and the wall behind the chair. She also failed to disinfect the BP cuff, that was folded in the basket holder, located on the right side of the machine, the hand sanitizer bottle, television, and the arm extender of the television. During an interview on 1/21/25 at 9:30 A.M., CCHT #7 said she should have removed the prime waste bucket, emptied it, and then cleaned it. She also said she should have cleaned all areas, because they are part of the station. 2. The facility failed to ensure that RN #2 did not dispose of prime waste into the dialysis station wall box. On 1/22/25 at 11:06 A.M., the surveyor observed RN #1 disinfect station 3 for the next patient. RN #1 removed the prime waste bucket from the machine and disposed of the contents into the wallbox, located behind the dialysis chair, not in the dirty sink or utility hopper. During an interview on 1/22/24 at 11:30 A.M., RN #1 said she does not use the dirty sink to dispose of prime waste. She did not know she should not use the wall box to dispose of it. 3. The facility failed to ensure 7 of 24 blood pressure cuffs were free from debris to allow for proper disinfection. On 1/21/25 at 9:00 A.M., during an observation of the treatment floor, the surveyor observed 7 of 24 BP cuffs, including those at station 3, 6, 10, 12, 15, 17, and 20, laden with lint and debris embedded in the Velcro of the BP cuff, making it difficult to adequately disinfect between patients. During an interview on 1/21/25 at 9:30 A.M., CCHT #7 said that she cleans the BP cuffs with bleach pads the best she can, and hope they are disinfected enough. 37349”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 37349 Based on observation, interview, and policy review, the facility failed to ensure that 1 of 3 staff members observed (Certified Clinical Hemodialysis Technician [CCHT] #2), implemented adequate infection control practices to reduce the risk of infection for 1 of 3 patient (#9) observations of initiation of dialysis with an arteriovenous fistula or graft (AVF/G). Findings include: Review of the facility policy, entitled Access Assessment and Cannulation, published 5/6/24, included the following: * Disinfect cannulation site as follows using any of the disinfectants below: * 70% isopropyl alcohol pad: using gentle friction, clean the access site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry before cannulating. On 1/21/25 at 10:05 A.M., the surveyor observed CCHT #2 initiate dialysis treatment for Patient #9. She disinfected the lower access site with an alcohol pad for 20 seconds, allowed it to dry, and then cannulated. She then disinfected the upper access site with an alcohol pad for 15 seconds, allowed it to dry, and then cannulated. She failed to disinfect the sites for 30 seconds, per the facility policy. On 1/21/25 at 10:30 A.M., CCHT #2 said she should have disinfected the cannulation sites for 30 seconds.”

“DIST SYS-CULTURE/LAL/SITES/FREQ(NEW)/LOG CFR(s): 494.40(a) 6.3.3 Water distribution systems: culture/LAL sample sites/frequency (new)/log Water distribution piping systems should be monitored for bacteria and endotoxin levels. Bacteria and endotoxins shall not exceed the levels specified in [AAMI] 4.1.2. [(i.e., bacteria <200 CFU/mL and endotoxin <2 EU/mL] Bacteria and endotoxin testing should be conducted at least monthly. For a newly-installed water distribution piping system, or when a change has been made to an existing system, it is recommended that weekly testing be conducted for 1 month to verify that bacteria or endotoxin levels are consistently within the allowed limits. Monitoring should be accomplished by taking samples from the first and last outlets of the water distribution loop and the outlets supplying reuse equipment and bicarbonate concentrate mixing tanks. If the results of this testing are unsatisfactory, additional testing (e.g., ultrafilter inlet and outlet, RO product water, and storage tank outlet) should be undertaken as a troubleshooting strategy to identify the source of contamination, after which appropriate corrective actions can be taken. Bacteria and endotoxin levels shall be measured as specified in ANSI/AAMI RD62:2001 (see 2.3). All bacteria and endotoxin results should be recorded on a log sheet to identify trends that may indicate the need for corrective action. This Standard is not met as evidenced by: 37349 Based on record review, interview, and policy review, the facility failed to ensure that microbial monitoring of the water system was completed monthly as required. Findings include: Review of the facility policy, entitled Microbiological Monitoring of Central Water and Concentrate Mixing and Delivery Systems, published 3/16/23, included the following: * Monthly: a frequency defined as being performed every 30 calendar days (+/- 5 days). * Microbiological samples will be collected no less than monthly. Review of the microbial monitoring logs, dated 8/1/24 through 1/22/25, indicated that water system and dialysis machine samples were obtained on 8/29/24, 9/30/24, 10/31/24, 11/4/24 and 12/26/24(52 days after the last microbial monitoring was conducted). During an interview on 1/22/24 at 2:30 P.M., the Biomedical Technician said he obtained monthly samples for microbial monitoring of the water system on the last Thursday of each month, but he missed it in November. He also said the testing completed on 11/4/24 was part of an action plan, due to an abnormal result obtained 10/31/24, and there should not be more than 30 days between monitoring.”

“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: 10249 Based on record review, interview, 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 5 of 7 applicable patient (#1, #7, #5, #4, and #6) records reviewed, out of a total sample of 9 patients. Findings Include: Review of the facility policy, entitled 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 #1, the facility failed to ensure that staff documented the TCD in the treatment record. Patient #1 was admitted to the facility in February 2024 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of 9 treatment sheets, dated 12/26/24 through 1/18/25, indicated that staff failed to document the TCD for 7 of 9 treatments including 12/28/24, 12/31/24, 1/2/25, 1/4/25, 1/9/25, 1/16/25, and 1/18/25. 2. For Patient #7, the facility failed to ensure that staff documented the TCD in the treatment record. Patient #7 was admitted to the facility in January 2015 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of 9 treatment sheets, dated 12/31/24 through 1/20/25, indicated that staff failed to document the TCD for 2 of 9 treatments including 12/31/24, and 1/15/25. 37349 3. For Patient #5, the facility failed to ensure that staff documented the TCD in the treatment record. Patient #5 was admitted to the facility in July 2015 with a diagnosis of End Stage Renal Disease, requiring dialysis. Review of 9 treatment sheets, dated 12/17/24 through 1/18/25, indicated that staff failed to document the TCD for 6 of 9 treatments including 1/2/25, 1/4/25, 1/9/25, 1/11/25, 1/16/25, and 1/18/25. 44223 4. For Patient #4, the facility failed to ensure that staff documented the TCD in the treatment record. Patient #4 was admitted to the facility in October 2018 with a diagnosis of End Stage Renal Disease, requiring hemodialysis. Review of the 9 treatment sheets, dated 12/31/24 through 1/20/25, indicated that staff failed to document the TCD for 8 of 9 treatments, including 12/31/24, 1/3/25, 1/6/25, 1/8/25, 1/10/25, 1/13/25, 1/15/25, and 1/17/25. 5. 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 July 2024 with a diagnosis of End Stage Renal Disease, requiring hemodialysis. Review of 9 treatment sheets, dated 1/2/25 through 1/20/25, indicated that staff failed to document the TCD for 7 of 9 treatments, including 1/2/25, 1/6/25, 1/8/25, 1/10/25, 1/13/25, 1/17/25, and 1/20/25. During an interview on 1/22/25 at 2:00 P.M., the Facility Administrator said staff should be documenting the TCD on the flow sheets, with each treatment. During an interview on 1/22/25 at 2:05 P.M., the Director of Operations said prior to treatment when staff are performing safety checks, they should be documenting the TCD.”

“MICROB MONITOR-SAMPLE BEFORE DISINFECT CFR(s): 494.40(a) 7.2 Microbial monitoring methods 7.2.1 General: samples before disinfect Samples should always be collected before sanitization/disinfection of the water treatment system and dialysis machines. This Standard is not met as evidenced by: 37349 Based on interview, record review, and policy review, the facility failed to ensure that microbial monitoring samples were obtained before disinfection of the water treatment system and dialysis machines. Findings include: Review of the facility policy, entitled Microbiological Monitoring of Central Water and Concentrate Mixing and Delivery Systems, Published 3/16/23, included the following: * Samples will be collected prior to disinfection and within 96 hours of system disinfection. During the tour of the water room on 1/22/25 at 12:45 P.M., the Biomed Technician said the water system is disinfected every Tuesday. Review of the disinfection logs, dated November 2024, December 2024, and January 2025, indicated the water system was disinfected every Tuesday. Review of the microbial monitoring logs, dated 8/1/24 to 1/22/25, indicated that water system and dialysis machine samples were obtained on the following days: -8/29/24 (Thursday) after disinfection, greater than 96 hours of system disinfection. -9/30/24 (Monday). -10/31/24 (Thursday) after disinfection, greater than 96 hours of system disinfection. -11/4/24 (Monday). -No samples were obtained from the the water system or dialysis machines the last Thursday of November. -12/26/24 (Thursday) after disinfection, greater than 96 hours of system disinfection. During an interview on 1/22/25 at 12:45 P.M., the Biomed Technician said the water system is disinfected every Tuesday, and he typically obtains microbial monitoring samples on the last Thursday of the month. He said he was not aware of a policy to obtain samples prior to disinfecting the water system. During an interview on 1/22/25 at 3:30 P.M., the Area Technical Operations Manager said if the water system is disinfected on Tuesday, the microbial samples should be obtained either Monday or Tuesday prior to disinfection of the system.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 37349 Based on record review and staff interview, the facility failed to ensure that the Interdisciplinary Team (IDT) developed and implemented a written, individualized plan of care (POC) for each patient that included services necessary to address patients’ needs and changes in patients’ condition, measurable and expected outcomes, and estimated timetables to achieve these outcomes in regard to dialysis access for 4 of 4 applicable Patients (#5, #3, #6, and #1) with a Central Venous Catheter (CVC), out of a total sample of 9 patients. Findings include: 1. For Patient #5, the facility failed to ensure the patient had a complete and individualized POC that included estimated timetables, and measurable goals in regard to dialysis access infections. Patient #5 was admitted to the facility in July 2015 with diagnoses which included end stage renal disease, requiring hemodialysis, and received hemodialysis through a CVC for his/her dialysis treatments. Review of a hospital discharge summary, dated 9/3/24, indicated the patient presented to the Emergency Room from the dialysis center due to a concern for a clotted fistula. A tunneled hemodialysis access (CVC) was placed on 8/30/24. Review of a hospital discharge summary, dated 10/11/24, indicated the patient was admitted due to sepsis secondary to the principal problem of bacteremia (presence of bacteria in the bloodstream). The CVC was removed on 9/30/24, cultures from the dialysis catheter were positive for MSSA (Methicillin-Susceptible Staphylococcus aureus). Review of a hospital discharge summary, dated 12/30/24, indicated the patient was admitted due to septicemia from MSSA positive for streptococcus mitis. The catheter was removed and replaced. Review of the most current Plan of Care, dated 10/31/24, included a problem of “Dialysis Access” was created on 9/5/24 with a goal and interventions to have no catheter. Use CVC while waiting for vascular surgeon decision on new permanent access. The plan failed to include a goal or interventions to remain infection free while utilizing the CVC. During an interview on 1/22/25 at 11:45 A.M., the Charge Nurse said that patients with a CVC should have a plan of care with a goal and interventions to remain infection free. She said for Patient #5 that goal should have been in place when the CVC was placed in August 2024, and updated with further interventions after the access became infected in September 2024, and December 2024. 44223 2. For Patient #3, the facility failed to ensure the patient had a complete and individualized plan of care that included estimated timetables and measurable goals regarding preventing dialysis access infections. Patient #3 was admitted to the facility in May 2024 with a diagnosis of End Stage Renal Disease, requiring hemodialysis, and received dialysis through a CVC. Review of the current Plan of Care, dated 8/29/24, included a problem of “Dialysis Access” that was created on 8/29/24 with a goal and intervention for no catheter. The Plan of Care failed to include a goal or interventions to remain infection free while utilizing the CVC. During an interview on 1/22/25 at 11:45 A.M., the Charge Nurse said that patients with a CVC should have a plan of care with a goal and interventions to remain infection free. 3. For Patient #6, the facility failed to ensure the patient had a complete and individualized plan of care that included estimated timetables and measurable goals regarding dialysis access infections. Patient #6 was admitted to the facility in July 2024 with a diagnosis of End Stage Renal Disease, requiring hemodialysis, and received dialysis through a CVC. Review of the current Plan of Care, dated 10/31/24, included a problem of “Dialysis Access” that was created on 9/29/24 with a goal and interventions for no catheter. The Plan of Care failed to include a goal or interventions to remain infection free while utilizing the CVC. During an interview on 1/22/25 at 11:45 A.M., the Charge Nurse said that patients with a CVC should have a plan of care with a goal and interventions to remain infection free. 10249 4. For Patient #1, the facility failed to ensure the patient had a complete and individualized POC that included estimated timetables, and measurable goals in regard to dialysis access infection. Patient #1 was admitted to the facility in February 2024 with diagnoses which included end stage renal disease, and received dialysis through a CVC for his/her dialysis treatments. Review of the most recent Plan of Care, dated 12/23/24, including a problem of “Dialysis Access” that was created on 2/28/24 with a goal and intervention for no catheter. The Plan of Care failed to include a goal or interventions to remain infection free while utilizing the CVC. During an interview on 1/22/25 at 11:45 A.M., the Charge Nurse said that patients with a CVC should have a plan of care with a goal and interventions to remain infection free.”

“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: 10249 Based on record review, and interview, the facility failed to ensure the dialysis treatment order was delivered as prescribed, relative to Blood Flow Rate (BFR-speed measured in milliliters per minute [ml/min]) in which the patient’s blood is pushed through the dialyzer and back into the body) and Dialysate Flow Rate (DFR-the measurement of how fast the dialysate solution flows in ml/min to draw toxins from the patient’s blood) for 2 of 7 applicable Patients (#1, #2) records reviewed, out of total sample of 9 patients. Findings include: 1. Patient #1 was admitted to the facility in February 2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the physician orders, dated 12/26/24, indicated the dialysis order included a BFR to be delivered at a rate of 400 ml/min, and a DFR to be delivered at a rate of 800 ml/min. Review of the 9 hemodialysis flowsheets, dated 12/26/24 through 1/18/25, indicated the BFR and/or DFR had not been delivered as prescribed for 4 of 9 treatments, including the following: *1/4/25 - The BFR was delivered at a rate of 350 ml/min, not the 400 ml/min as ordered, and there was no documentation to indicate why the physician’s orders was not followed. *1/9/25 - The BFR was delivered at a rate of 300 ml/min, not the 400 ml/min as ordered, and there was no documentation to indicate why the physician’s orders was not followed. *1/16/25 - The BFR was delivered at a rate of 375 ml/min, not the 400 ml/min as ordered, and there was no documentation to indicate why the physician’s orders was not followed. *1/18/25 - The BFR was delivered at a rate of 350 ml/min, not the 400 ml/min as ordered, and the DFR was running at 700 ml/min and not 800 ml/min. as ordered, and there was no documentation to indicate why the physician’s orders was not followed. 2. Patient #2 was admitted to the facility in December 2024 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the physician orders, dated 12/20/24, indicated the dialysis order included a BFR to be delivered at a rate of 250 ml/min, and a DFR to be delivered at a rate of 800 ml/min. Review of the 9 hemodialysis flowsheets, dated 12/20/24 through 1/20/25, indicated the BFR and/or DFR had not been delivered as prescribed for 2 of 9 treatments, including the following: *12/31/24 - The BFR was delivered at a rate of 200 ml/min, not the 250 ml/min as ordered, and there was no documentation to indicate why the physician’s orders was not followed. *1/20/25 - The DFR was delivered at a rate of 500 ml/min, not the 800 ml/min as ordered, and there was no documentation to indicate why the physician’s orders was not followed. During an interview on 1/22/25 at 2:00 P.M., the Facility Administrator said staff should first communicate with the physician, then document in the flow sheet if there is a change needed in the BFR and/or the DFR.”

“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: 37349 Based on observation, staff interview, and policy review, the facility failed to ensure that 1 of 3 staff members (Certified Clinical Hemodialysis Technician [CCHT] #2) observed, evaluated a vascular access to ensure functionality by listening for the bruit the length of the access (swooshing sound heard with the stethoscope placed over the access) for 1 of 3 applicable patients (#9) with a Arteriovenous Fistula/Graft (AVF/G) access site, out of a total sample of 9 patients. Review of the facility policy, entitled Assessment and Cannulation, published 5/6/24, included the following; *Before each treatment, the internal access must be assessed for patency, signs of infection and any abnormal findings. *Evaluation and preparation of the access will be performed routinely prior to cannulation at each dialysis session. *Look. *Listen: Staff should listen to the entire length of the access for changes in the sound of the bruit- a normal low-pitched bruit should be present. *Feel: Thrill should have one of two sensations - a purring like a cat, or a vibration like a cell phone. It should not pulsate. Strong pulsation suggests that there is a flow issue due to a stenosis and needs to be referred immediately for further evaluation and possible intervention. During an observation on 1/21/25 at 10:05 A.M., the surveyor observed CCHT #2 as she was preparing Patient #9 for his/her dialysis treatment via an AVF. CCHT #2 looked at the AVF and felt the vascular access with her fingertips, disinfected the site, applied the tourniquet, and then inserted the needle into the lower access. She then proceeded to repeat this and insert the second needle into the upper access. CCHT #2 failed to listen to the length of the access for the presence of a bruit prior to using the access. During an interview on 1/21/25 at 11:25 A.M., CCHT #2 said she should have listened for a bruit.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 10249 Based on review of the facility Quality Assessment Performance Improvement (QAPI) committee meeting minutes, review of the monthly infection control audits, interview, and policy review, the facility failed to ensure monthly visual infection control audits were completed for arteriovenous fistula and graft (AVF/AVG) disinfection compliance, to ensure they could be consistently measured, analyzed, and a plan developed based on the results of monthly infection control audits. Findings include: Review of the facility policy, titled, Quality Assessment and Performance Improvement Program, dated 11/4/24, indicated the following: *The QAPI Committee will monitor data/information, prioritize areas for improvement, determine potential root cause analysis, develop, implement, evaluate and revise action plans that results in sustainable improvements in patients care. *Elements to be reviewed will include: -Patient care outcomes. -Infection surveillance. -Patient safety. -Staff training and education. *An effective and successful review of QAPI meeting and program activities will include: -Analysis of QAPI trending tool. -Review of the results of required self-audits. During the survey, 1 of 3 staff observed had infection control breaches during initiation of hemodialysis treatment for a patient with an AVF. Certified Clinical Hemodialysis Technician [CCHT] #2 failed to disinfect each access site for 30 seconds, per facility policy. Review of the facility monthly visual infection control audit checklist for 12 months (January 2024 through December 2024) failed to include audits of care for patients with Arterio-Venous Fistula (AVF) and Arterio-Venous Graft (AVG) access. During an interview on 1/22/25 at 1:30 P.M., the Facility Administrator said they do not monitor AVF/G during monthly visual infection control audits.”

“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: 10249 Based on observation, record review, staff interview, and policy review, the Medical Director failed to 1.) 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 5 of 7 applicable patients (#1, #2, #7, #3, and #6); and 2.) ensure 1 of 2 staff (Registered Nurse [RN] #2) observed, followed the policy related to reversal of Central Venous Catheter (CVC) lines for 1 of 2 applicable Patients (#8), out of a total sample of 9 patients. Findings Include: 1. For Patient #1, #2, #7, #3, and #6, the Medical Director failed to ensure staff adhered to the heparin administration policy and documented that they waited 3-5 minutes after heparin bolus to initiate dialysis treatments. Review of the facility’s policy, titled Heparinization, published 8/3/2020, indicated the following: * Heparin Administration * Heparin must be given at least 3-5 minutes prior to dialysis. This allows time for the full anticoagulation at the start of treatment. Administer into the second inserted access needle or catheter 3-5 minutes prior to hemodialysis treatment initiation. a. Patient #1 had a physician’s order, dated 12/26/24, to administer heparin bolus 2000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 12/26/24 through 1/18/25, indicated for 6 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 12/26/24 treatment started at 11:45 A.M., heparin was documented as administered at 11:43 A.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 12/28/24 treatment started at 11:52 A.M., heparin was documented as administered at 11:50 A.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/2/25 treatment started at 11:47 A.M., heparin was documented as administered at 11:45 A.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/9/25 treatment started at 11:39 A.M., heparin was documented as administered at 11:37 A.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/13/25 treatment started at 11:44 A.M., heparin was documented as administered at 11:46 A.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/18/25 treatment started at 12:06 P.M., heparin was documented as administered at 12:04 P.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. b. Patient #2 had a physician’s order, dated 12/20/24, to administer heparin bolus 2000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 12/20/24 through 1/20/25, indicated for 6 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 12/20/24 treatment started at 12:11 P.M., heparin was documented as administered at 12:09 P.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 12/24/24 treatment started at 10:42 A.M., heparin was documented as administered at 10:40 A.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 12/29/24 treatment started at 11:34 A.M., heparin was documented as administered at 11:32 A.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/3/25 treatment started at 11:33 A.M., heparin was documented as administered at 11:31 A.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/17/25 treatment started at 11:55 A.M., heparin was documented as administered at 12:04 P.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/20/25 treatment started at 11:43 A.M., heparin was documented as administered at 1:03 P.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. c. Patient #7 had a physician’s order, dated 12/27/24, to administer heparin bolus 2000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 12/31/24 through 1/20/25, indicated for 5 of 9 treatments staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 1/3/25 treatment started at 5:30 A.M., heparin was documented as administered at 5:28 A.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/6/25 treatment started at 5:37 A.M., heparin was documented as administered at 5:35 A.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/8/25 treatment started at 5:32 A.M., heparin was documented as administered at 5:30 A.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/10/25 treatment started at 5:37 A.M., heparin was documented as administered at 5:35 A.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. *On 1/13/25 treatment started at 5:30 A.M., heparin was documented as administered at 5:30 A.M., not the 3-5 minutes prior to the initiation of dialysis, per the facility policy. 44223 d. Patient #3 had a physician’s order to administer heparin bolus 2000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 12/30/24 through 1/18/25, indicated for 6 of 9 treatments, staff failed to wait 3-5 minutes after administration of heparin to initiate treatment including the following: *On 1/4/25 treatment started at 11:43 A.M., heparin was documented as administered at 11:41 A.M., 2 minutes prior to initiation of treatment, not the 3-5 minutes prior initiation of dialysis, per the facility policy. *On 1/7/25 treatment started at 11:32 A.M., heparin was documented as administered at 11:37 A.M., 5 minutes after initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 1/9/25 treatment started at 11:39 A.M., heparin was documented as administered at 11:41 A.M., 2 minutes after initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 1/11/25 treatment started at 11:41 A.M., heparin was documented as administered at 11:39 A.M., 2 minute prior to initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 1/16/25 treatment started at 11:35 A.M., heparin was documented as administered at 12:06 P.M., 31 minutes after initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 1/18/25 treatment started at 11:49 A.M., heparin was documented as administered at 11:56 A.M., 7 minutes after initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. e. Patient #6 had a physician’s order to administer heparin bolus 2000 units intravenously (IV) push, every dialysis treatment. Review of 9 treatment sheets, dated 1/2/25 through 1/20/25, indicated for 3 of 9 treatments, staff failed to wait 3-5 minutes after administration of heparin to initiate treatment, including the following: *On 1/2/25 treatment started at 10:04 A.M., heparin was documented as administered at 10:02 A.M., 2 minutes prior to initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 1/4/25 treatment started at 10:06 A.M., heparin was documented as administered at 10:04 A.M., 2 minutes prior to initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. *On 1/17/25 treatment started at 11:12 A.M., heparin was documented as administered at 11:10 A.M., 2 minutes prior to initiation of treatment, not the 3-5 minutes prior to initiation of dialysis, per the facility policy. During an interview at 1/22/25 at 2:00 P.M., the Facility Administrator said staff should wait 3-5 minutes before initiating treatment, after administering bolus heparin. 2. For Patient #8, The Medical Director failed to ensure staff followed the facility policy related to notifying the physician and obtaining an order when reversing treatment lines. Patient #8 was admitted to the facility in January 2025 with a diagnosis of End Stage Renal Disease, requiring hemodialysis. On 1/21/25 at 10:10 A.M., the surveyor observed Certified Clinical Hemodialysis Technician (CCHT) #7 terminate dialysis treatment for Patient #8 via a CVC. Prior to termination the surveyor observed that the bloodlines were reversed. CCHT #7 confirmed the blood lines were reversed and that Registered Nurse (RN) #2 had reversed the lines during treatment. During an interview on 1/21/25 at 10:30 A.M., RN #2 said she reversed the lines due to high arterial pressures. She said the Patient had a standing physician order to reverse the lines if needed. Review of the medical record on 1/22/25 failed to indicated that Patient #8 had a physician order to reverse lines. Further review of the medical record indicated there was no documented evidence that the physician was notified that the lines had been reversed. During an interview on 1/22/25 at 9:30 A.M., the Director of Operations said there should be a physician order, under the special attention section, to reverse lines. The Director of Operations said the patient did not have an order to reverse lines.”