Davita Pentagon City Dialysis

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 46466 Based on observations, interviews and facility document review, it was determined the facility failed to remove PPE (Personal Protective Equipment) prior to leaving the treatment floor per facility policy. The findings include: On June 4, 2025 at 11:35 AM, 11:45 AM, 11:46 AM, 11:49 AM, 12:07 PM, 12:35 PM and 2:15 PM, two (2) staff members were observed leaving the treatment floor to go into the patient lobby/hallway to obtain patient wheelchairs and/or patient dialysis chairs. Both staff members did not remove their PPE prior to leaving the treatment floor. On June 4, 2025 at 12:00 PM, an interview was conducted with Staff Member #2. Staff Member #2 stated that the staff members leave the treatment floor only to get patient wheelchairs and return back to the floor. Staff Member #2 stated that staff members should not be wearing their PPE after leaving the treatment floor. A review of the facility’s policy “Infection Control For Dialysis Facilities”, revised April 2023, indicated in part: “...PPE (i.e., gown, gloves, eye protection, face shield)...5...PPE is to be: a. Removed prior to leaving the treatment area”.”

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 42929 Based on interviews and facility document review, it was determined the facility failed to contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. Findings: The facility’s policy titled “Facility Emergency Management Plan” last revised April 2024, states in part: ... 11. The FA [facility administrator], or designee, shall have communication at least on an ANNUAL basis with the following local agencies regarding emergency preparedness, event collaboration and communication, needs of the dialysis patients and facility and reviewing agency’s emergency plan. Communication template available on the DEM webpage. NOTE: documentation of contact is important: a. Local Emergency Management Agency ... On July 15, 2024, the surveyor reviewed the facility’s emergency preparedness documentation provided by Staff Member #1. There was no documentation that the facility contacted the local emergency preparedness agency. On July 16, 2024, Staff Member #4 confirmed that there was no documentation that the facility contacted the local emergency preparedness agency as per the regulation and the facility’s policy.”

“Policies for Evac. and Primary/Alt. Comm. CFR(s): §403.748(b)(3), §416.54(b)(2), §418.113(b)(6)(ii), §441.184(b)(3), §460.84(b)(3), §482.15(b)(3), §483.73(b)(3), §483.475(b)(3), §485.68(b)(1), §485.542(b)(3), §485.625(b)(3), §485.727(b)(1), §485.920(b)(2), §491.12(b)(1), §494.62(b)(2) [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(3) or (1), (2), (6)] Safe evacuation from the [facility], which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For RNHCIs at §403.748(b)(3) and ASCs at §416.54(b)(2) and REHs at §485.542(b)(3):] Safe evacuation from the [RNHCI or ASC or REHs] which includes the following: (i) Consideration of care needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communication with external sources of assistance. * [For CORFs at §485.68(b)(1), Clinics, Rehabilitation Agencies, OPT/Speech at §485.727(b)(1), and ESRD Facilities at §494.62(b)(2):] Safe evacuation from the [CORF; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; and ESRD Facilities], which includes staff responsibilities, and needs of the patients. * [For RHCs/FQHCs at §491.12(b)(1):] Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients. This Standard is not met as evidenced by: 42929 Based on observations, interviews, and facility document review, it was determined the facility failed to ensure that there were breakaway locks on the evacuation kit and that patients’ treatment orders and medication lists were updated and replaced monthly. Findings: The facility’s policy titled “Facility Emergency Management Plan” revised April 2024, states in part: ... Each evacuation kit(s) should contain: a. Copy of each patients treatment orders and medication list. FA [facility administrator] or designee will verify patient information is updated and replaced at least monthly.... 7. ... The date and initials of the teammate checking the contents should be placed on a label outside the kit(s). 8. Evacuation kit will be sealed with a breakaway lock and is only to be opened in the event of an emergency situation, monthly review, and/or the replacement of outdated item.... On July 15, 2024, at 9:50 a.m. the surveyor observed the evacuation kit contained no breakaway locks and the patient information sitting on top of the evacuation kit was printed April 16, 2024. The surveyors notified Staff Member #1 and Staff Member #4 that there were no breakaway locks on the evacuation kit and that the patient information was not updated monthly as per policy.”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 42929 Based on observation, interview, and document review, it was determined the facility failed to provide emergency preparedness orientation and training to four (4) of four (4) patient’s (Patient #’s 1, 2, 3, and 4) sampled. Findings: The facility’s policy titled “Emergency Management Plan” revised April 2024, states in part: ... Training and Education. Emergency Management Plan 1. The FA [facility administrator], or designee, is responsible to provide training of EMP: ... b. Patients: i. ANNUALLY. 1. Facility specific emergency response procedures. a. What to do if an emergency occurs within the facility. i. Fire safety. ii. Disconnection from dialysis machine. iii. Emergency equipment as applicable. b. Where to go if an emergency occurs, to include emergency evacuation route(s) and shelter in place location(s) (as applicable). 2. Personal / family / pet preparedness, to include, but not limited to: a. What to do if an emergency occurs away from the facility ... b. Where to go in an emergency ... c. Who to call in an emergency ... ii. QUARTERLY. 1. Fire Safety Preparedness. 2. Emergency Take-off procedures. iii. Upon admission to the facility. iv. Any changes and/or updates to EMP [emergency management plan] or facility specific emergency procedures. v. Document training on applicable forms ... On July 16, 2024, at 2:30 p.m. Staff Member #1 confirmed that there was no emergency preparedness training documentation in the four (4) patient’s medical records that the surveyors reviewed, Patient #1, Patient #2, Patient #3, and Patient #4.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 42929 Based on nine (9) infection control observations, interviews, and facility document review, it was determined the facility staff failed to perform hand hygiene after glove removal and between each patient or station. Findings: The facility’s policy titled “Infection Control for Dialysis Facilities” revised April 2023, states in part: ... Hand Hygiene. 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact, e. after interacting with wall boxes. f. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse ... PPE (i.e., gown, gloves, eye protection, face shield) ... On July 15, 2024, at 10:45 AM during discontinuation of treatment with a central venous catheter (CVC), Staff Member #7 did not perform hand hygiene after removing gloves on three (3) separate occasions. On July 15, 2024, at 10:55 AM, Staff Member #7 picked up the sharps container by placing hand inside the sharps container opening to grab the container, while not wearing gloves, and also grabbed a trash can while not wearing gloves. Staff Member #7 did not perform hand hygiene, then proceeded to retrieve clean clamps and gauze pads, then brought the supplies to station #5, did not perform hand hygiene, then donned new gloves. On July 15, 2023, at 10:58 AM, Staff Member #7 touched the staff member’s face shield with ungloved hands, then touched a patient’s machine without performing hand hygiene with ungloved hands. Staff Member #7 donned gloves, then touched the staff member’s face shield and then proceeded to touch the patient to discontinue treatment. On July 15, 2024, at 11:00 AM, Staff Member #7 removed gloves, did not perform hand hygiene, then donned new gloves. At 11:02 AM, Staff Member #7 removed the staff member’s face shield with gloved hands then wiped up patient’s blood, then put on face shield, then changed gloves and did not perform hand hygiene. At 11:04, Staff Member #7 at station #3, removed gloves, did not perform hand hygiene, then donned new gloves. At 11:05, Staff Member #7 removed gloves, did not perform hand hygiene, then donned new gloves. On July 15, 2024, at 11:09 AM, Staff Member #8 removed gloves, did not perform hand hygiene, then retrieved supplies from the clean supply cart. On July 15, 2024, at 11:12 AM, while initiating treatment for a patient with a CVC at station #2, Staff Member #7 removed gloves, did not perform hand hygiene, then donned new gloves. Staff Member #7 removed gloves again, did not perform hand hygiene, then donned new gloves. Staff Member #7 then walked over to the patient at station #3, removed the blood pressure cuff from the patient’s arm, then placed the blood pressure cuff on the arm of the patient at station #2, without cleaning the blood pressure cuff between patients. On July 15, 2024, at 11:16 AM, Staff Member #7 removed gloves, did not perform hand hygiene, then donned new gloves. At 11:17 AM, Staff Member #7 touched the lid of the biohazard waste bin while wearing gloves to throw something away, then went back to touching a patient’s lines and detached the patient from the machine with the same gloves that touched the biohazard waste bin. On July 15, 2024, at 11:32 AM, Staff Member #7 touched the patient’s machine without wearing gloves. Staff Member #13 indicated that Staff Member #7 should be wearing gloves when touching the patient machines. On July 15, 2024, at 11:35 AM, the surveyor observed Staff Member #7 initiate dialysis on an unsampled patient with a CVC. After examining the CVC, Staff Member #7 changed gloves, but did not perform hand hygiene. Staff Member #7 then picked up trash off the floor with the clean gloves on, moved a sharps container from another station to the current workstation, and removed gloves with no hand hygiene. Staff Member #7 cleansed one catheter hub, removed gloves, and did not perform hand hygiene. Staff Member #7 cleansed the second catheter hub and removed gloves without performing hand hygiene. During CVC care, the staff member was observed changing gloves a total of six (6) times and only observed performing hand hygiene once after initiating the dialysis treatment, missing five (5) of six (6) opportunities for hand hygiene during catheter care. During an interview on July 15, 2024, at 11:45 AM, Staff Member #3 indicated that the facility is working on infection control. During an interview on July 15, 2024, at 1:49 PM, Staff Member #2 indicated that the facility has been focusing on improving hand hygiene and that infection control is “lacking”. During an interview on July 16, 2024, at 1:46 PM, Staff Member #9 indicated that some patient care technicians (PCTs) touch machines without gloves and do not wear PPE, like masks and gowns, “when it’s hot”. On July 16, 2024, at 12:45 PM, Staff Member #4 indicated that infection control audits were not completed for January 2024, April 2024, May 2024, and June 2024, when they should be completed monthly. The governing body meeting minutes revealed that the facility completed infection control in-services in April 2024.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 42929 Based on observations, interviews, and facility document review, it was determined the facility staff failed to ensure all persons in the treatment area were wearing appropriate personal protective equipment (PPE). The findings include: The facility’s policy titled “Infection Control for Dialysis Facilities” revised April 2023, states in part: ... 6. Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates, Physicians and Non-Physician (NPP) and visitors when in the treatment area.... On July 15, 2024, at 10:02 AM the surveyors observed a nurse from the skilled nursing facility enter the dialysis treatment area to provide medications to a patient. The nurse looked surprised when the dialysis staff member asked the nurse to put on a mask and gown to go on the treatment floor. The nurse donned the gown backwards and asked the dialysis staff member for assistance in buttoning the gown, as the buttons were now at the nurse’s back. On July 15, 2024, at 10:35 AM four (4) emergency medical technicians (EMTs) arrived at the unit to take a patient to the hospital. Two (2) additional EMTs arrived at the facility and assisted with the patient on the treatment floor. The dialysis staff did not offer the EMTs personal protective equipment (PPE) and the EMTs did not wear any PPE, including mask and gown, while on the treatment floor. On July 15, 2024, at 11:04 AM, Staff Member #6 sat at a computer on the treatment floor without wearing PPE to include a gown or a mask. During an interview on July 16, 2024, at 1:46 PM, Staff Member #9 indicated that some patient care technicians touch machines without gloves and do not wear PPE, like masks and gowns, “when it’s hot”. On July 16, 2024, at 12:45 PM, Staff Member #4 indicated that infection control audits were not completed for January 2024, April 2024, May 2024, and June 2024, when they should be completed monthly.”

“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: 42929 Based on one (1) infection control observation, interviews, and facility document review, it was determined the facility staff failed to disinfect a blood pressure cuff before using it on another patient. Findings: The facility’s policy titled “Infection Control for Dialysis Facilities” revised April 2023, states in part: ... 14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses.... On July 15, 2024, at 11:12 AM, while initiating treatment for a patient with a central venous catheter (CVC) at station #2, Staff Member #7 walked over to the patient at station #3, removed the blood pressure cuff from the patient’s arm, then placed the blood pressure cuff on the arm of the patient at station #2, without cleaning the blood pressure cuff between patients. The surveyor discussed the above concern with Staff Member #4 on July 16, 2024.”

“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: 42929 Based on two (2) infection control observations, interviews, and facility document review, it was determined the facility staff failed to ensure cleaning and disinfecting of dialysis chairs. Findings: The facility’s policy titled “Infection Control for Dialysis Facilities” revised April 2023, states in part: ... Disinfection. 12. ... a. Prior to routine disinfection, remove all visible blood. i. For visible blood or gross blood spills, a 1:10 (one to ten) bleach solution must be utilized. ii. After all visible blood is cleaned with the 1:10 (one to ten) bleach solution teammates are to use a new disposable towel soaked with 1:10 (one to ten) bleach solution and clean area a second time. iii. Cleaning of visible blood should be performed when first observed. b. Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. ... 13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by health care personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops). i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system. ... ii. Priming containers are to be emptied prior to disinfection.... On July 15, 2024, at 10:02 AM Staff Member #11 indicated that most patients come to the dialysis facility transported on a dialysis chair. The nursing facility staff clean the dialysis chairs after they transport the patient who has completed dialysis treatment back to the nursing facility, and prior to picking up the next patient to bring them to dialysis. Staff Member #11 stated that the nursing home transport staff clean the chairs. On July 15, 2024, at 10:32 AM the surveyor observed Staff Member #7 bring a dialysis chair in from the waiting area to station #2. The chair upholstery was ripped, torn, taped, and there were cracks all over the chair. The surveyor observed what appeared to be blood on the inside and top of the left arm of the chair. Staff Member #7 stated the chair had been cleaned and that the red marks were a “stain” and not blood. The surveyor requested for the staff member to wipe the chair with a bleach wipe. Staff Member #7 wiped the arm of the chair and the red marks disappeared. There was still some blood on the top of the chair arm that the staff member did not wipe. Staff Member #7 covered the chair with a blanket and placed a patient in the chair to complete their dialysis treatment. On July 15, 2024, at 10:54 AM, Staff Member #8 cleaned the top of the dialysis machine and then placed the dirty blood pressure cuff on top of the cleaned machine to wipe the cuff and then turned the cuff over and placed the cleaned side on the dirty machine to wipe the other side of the cuff. On July 15, 2024, at 11:26 AM, Staff Member #13 indicated that the patient transporters that work for the nursing facility sanitize the dialysis chairs after the patients are transported to their nursing facility room after dialysis. Staff Member #13 indicated that the transporters use “Sani Wipes’’ to clean the chairs. Staff Member #13 was unsure about who trained the transporters on cleaning dialysis chairs. Staff Member #13 stated that the facility is working with the nursing facility to have the patients come to the dialysis facility in the patient’s own chair. During an interview on July 15 2023, Staff Member #4 indicated that the facility requested for the nursing facility to use bleach solution to clean the chairs in between patients, but the nursing facility indicated that they are approved to use sani wipes, so that is what their staff will use to clean the dialysis chairs. Staff Member #4 confirmed that the chair cleaning for the nursing facility patients has been a challenge. During an interview on July 15, 2023, at 12:28 PM, the nursing facility patient transporter indicated that there are usually two (2) designated nursing facility transporters. The transporters take the patient to the patient’s room after the patient is finished dialysis treatment, then the transporter cleans the dialysis chair with “sani wipes”, then the transporter picks up the next patient in the dialysis chair to take them to dialysis. The transporter indicated that the nursing facility trained the transporters on how to clean the dialysis chairs, how to open the side arms of the chairs, lift the side tables, and lay the chair back.”

“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: 42929 Based on interviews, personnel record review, medical record review, and facility document review, it was determined the facility staff failed to ensure two (2) of two (2) patients were offered the hepatitis B vaccine, and that two (2) of four (4) staff members were tested for hepatitis B after hire at the facility (Patient #’s 8 and 9 and Staff Member #’s 11 and 12). Findings: The facility’s policy titled “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” revised April 2024, states in part: ... 6. Documentation of the following will remain in the patient’s current active medical record: ... ... 10. An order will be obtained for hepatitis B vaccination. The patient is provided the Vaccination Information Sheet (VIS) and a consent form (included in Patient Registration Packet found in Reggie). The patient will consent to the vaccination or will decline. The completed form will be kept in the patient’s health record.... The facility’s vaccinations and surveillance report for hepatitis B dated July 15, 2024, revealed that Patient #8 was hepatitis B susceptible since November 28, 2023, and Patient #9 was hepatitis B susceptible since January 11, 2024, as per the documented lab results. During an interview on July 16, 2024, at 2:15 PM, Staff Member #1 confirmed that Patient #8 and Patient #9 were hepatitis B susceptible and there was no documentation in the patient’s medical records that the susceptible patients were offered the hepatitis B vaccine. The facility’s policy titled “Teammate Hepatitis B Monitoring and Follow up Guidance” revised April 2024, states in part: 1. New teammates who are not able to provide documentation of hepatitis B surface antibodies of 10 mIU/ml or greater from any time in the past, regardless of documentation indicating completion of the hepatitis B vaccine series, will be screened for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) within 10 days and offered the vaccination as indicated by their results.... On July 16, 2024, a review of the personnel file for Staff Member #7 revealed that the staff member’s hire date was November 27, 2023, and the staff member was tested for hepatitis B on April 12, 2024. On July 16, 2024, a review of the personnel file for Staff Member #12 revealed that the staff member’s hire date was September 11, 2023, and the staff member was tested for hepatitis B on April 12, 2024. On July 16, 2024, at 2:30 PM, Staff Member #1 provided hepatitis B test results for Staff Member #12 that were dated April 12, 2024, when the surveyor requested to receive the hepatitis B tests results that were completed for the staff member upon hire. On July 16, 2024, Staff Member #4 confirmed that the staff member’s should be tested for hepatitis B within 10 days of hire as per the facility’s policy.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the facility failed to ensure it maintained aseptic techniques when storing intravenous medications. Specifically, the facility failed to appropriately store medications, failed to remove expired medications from use, and failed to appropriately label intravenous medications. Findings: On July 15, 2024, at 9:50 AM the surveyor observed the evacuation kit contained multiple heparin vials that were not secured in the evacuation kit with a breakaway lock, as per the facility’s policy. Four (4) plastic vials of normal saline were observed in the evacuation kit that expired in February 2022. During observations at 10:00 AM on July 15, 2024, the surveyor observed a box labeled Mircera in the medication preparation area. The medication box had the words, Use First, written on it, but did not contain any other date. An interview with the Registered Nurse (RN, Staff Member #11) during the tour, revealed that the medication should be stored in the refrigerator, but could be left at room temperature for up to 28 days. Staff Member #11 confirmed the absence of a date on the medication. Staff member #11 confirmed there was no way to know how long the medication had been stored at room temperature and should not be used. Staff member #11 confirmed the medication should be labeled with time and date or refrigerator. The surveyor also observed 85 capsules of oral diphenhydramine 25 mg that expired in March of 2024 in the medication storage area. On July 15, 2024, at 10:02 AM the surveyor observed an open multidose vial of heparin at the nurse’s station with no date or staff member’s initials written on the bottle. The facility’s policy, Mircera Medication Policy was reviewed and reads in part: Mircera is refrigerated at 2 degrees Celsius to 8 degrees Celsius. Mircera should be allowed to warm to room temperature prior to preparation and administration. The facility policy titled “Medication Policy” revised October 2023, states in part: ... 13.... Do not use any medication that has been stored improperly or has expired. ... 29. Medications containing a preservative must be discarded [twenty-eight] 28 days after opening or accessed (e.g., needle punctured), unless the manufacturer specifies a different (shorter or longer) date or as directed by the manufacturer as in the case of vaccines or state specific pharmacy regulations. Each vial is labeled with the initials of the person opening the vial and the expiration date. ... 30. All medications in the facility are checked monthly. Insulin and other medications with preservatives are dated and initialed once opened. All medications are check monthly for expiration dates. 31. Medications are ordered and replaced prior to expiration. ... 32. Disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment and inventory areas and dispose of per state/local regulations.”

“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: 42929 Based on observations, interviews, and facility document review, it was determined the facility staff failed to aseptically initiate treatment for a patient with a central venous catheter (CVC) and conduct appropriate catheter care for two (2) of two (2) CVC care and treatment initiation observations. Findings: The facility’s policy titled “Central Venous Catheter (CVC) with Clearguard HD [hemodialysis] Antimicrobial End Caps Procedure” revised October 2023, states in part: ... NOTES: Use Dialysis Precautions and aseptic technique throughout procedure. ... Perform a [fifteen] 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason. Device Disinfectant and Skin Antiseptic: 2% Chlorhexidine Gluconate / 70% Isopropyl Alcohol: Effective for: CVC Access exit site, Effective Volume: 1 prepackaged swab, Effective Contact Time: [thirty] 30 seconds back and forth motion, Air Drying Time: 60 seconds. ... Procedure: 1. Perform hand hygiene per procedure. Hand hygiene protects patient and teammate from cross contamination. ... 4. Remove old dressing and discard. ... 7. Remove gloves and discard. Perform hand hygiene per procedure and re-glove. 8. Holding catheter with the non-dominant hand and using aseptic technique, clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds, apply to the CVC exit site in a “back and forth” pattern, using gentle friction progressing from the insertion site to the peripheral using both sides of the swab.... Then wait [sixty] 60 seconds for air dry time. Effective contact time for 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol is 30 seconds and dry time is 60 seconds. 9. Clean each CVC limb/cap with a new LARGE alcohol prep pad, starting close to the exit site and finishing with the cap. 10. Remove gloves and discard, perform hand hygiene per procedure and re-glove. ... 13. Apply label to the dressing indicating: Date dressing change was performed. Initials of TM performing procedure. 14. Remove gloves and discard, perform hand hygiene per procedure and re-glove. ... 16. Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for [fifteen] 15 seconds including the sides, threads and end of hub thoroughly with friction making sure to remove any residue, for example blood. Hold the limbs until the antiseptic has dried.... On July 16, 2024 at 11:35 AM, the surveyor observed Staff Member #7 initiate dialysis on an unsampled patient with a CVC. After examining the CVC, Staff Member #7 changed gloves, but did not perform hand hygiene. Staff Member #7 then picked up trash off the floor with the clean gloves on, moved a sharps container from another station to the current workstation, and removed gloves with no hand hygiene. Staff Member #7 cleansed one catheter hub, removed gloves, and did not perform hand hygiene. Staff Member #7 cleansed the second catheter hub and removed gloves without performing hand hygiene. During CVC care, the staff member was observed changing gloves a total of six (6) times and only observed performing hand hygiene once after initiating the dialysis treatment, missing five (5) of six (6) opportunities for hand hygiene during catheter care. On July 16, 2024, at 11:36 AM, Staff Member #7 scrubbed the CVC insertion site of the patient at station #3 for only five (5) seconds then immediately covered the site with gauze, not allowing the site to dry prior to applying the dressing. Staff Member #7 removed the dressing from the CVC lumens, did not change gloves and perform hand hygiene, then proceeded to scrub each lumen hub for only five (5) seconds. On July 16, 2024, the surveyors discussed the CVC observations with Staff Member #1 and Staff Member #4.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 36946 Based on staff interview, observation, and policy review, it was determined the facility failed to maintain a safe environment. Specifically, the facility failed to keep hallways free of clutter, inhibiting egress from the facility; failed to ensure access to the treatment floor was restricted to designated personnel; and failed to ensure oxygen tanks were stored securely. The findings include: On July 15, 2024 at 9:40 a.m, and July 16, 2024, at 1:46 PM, the surveyor observed seven (7) dialysis chairs in the dialysis waiting room and one (1) dialysis chair in the nursing facility hallway, all with worn, torn, taped, and cracked upholstery. The seven (7) chairs in the waiting room had signs indicating that the chair was not in use. Patients and visitors were observed seated opposite the chair in the hallway during treatment times on July 15 and 16, 2024, almost completely obstructing the hallway and preventing clear access to an exit door. The seven (7) chairs in the waiting room also partially blocked an exit door off of the waiting room. An interview was conducted with Staff Member #4 on 07/15/24 at 3:30 PM. Staff Member #4 stated that the chairs were not in use and the facility currently had no other place to store the chairs. During observations on July 16, 2024, the door to the treatment floor was noted to be partially open, allowing unrestricted access to the treatment area. An interview was conducted with Staff Member #11 who stated the door was malfunctioning and had to be pushed closed. Staff Member #11 confirmed the door should not be left open and stated maintenance had been contacted to repair the door. During a flash tour on July 16, 2024 at 10:25 AM, two (2) oxygen tanks were observed to be stored directly on the treatment floor and not secured. The facility’s policy, Physical Environment was reviewed and reads in part: Access to patient treatment area, waster treatment systems, supply storage and dialysis equipment is restricted to authorized personnel only...Supplies will not obstruct any fire exits or hallways. The facility’s policy, Emergency Equipment Checks was reviewed and reads in part: ...7. The oxygen tank(s) will be checked for an adequate amount of oxygen (500 psi or more) and stored in compliance with local and/or state regulations. A review of the LIS Virginia Law Code of Virginia Administrative Code: Title 4. Conservation And Natural Resources “ Agency 25. Department of Energy “ Chapter 40. Safety and Health Regulations for Mineral Mining “ Part VIII. Compressed Air, Gases, and Boilers-Surface and Underground “ 4VAC25-40-1250. Securing cylinders” states in part: Compressed gas or liquid gas cylinders shall be safely secured in an upright position. A review of the 2015 Virginia Statewide Fire Prevention Code states in part: ...5303.5.3 Securing Compressed Gas Containers, Cylinders and Tanks Compressed gas containers, cylinders and tanks shall be secured to prevent falling caused by contact, vibration or seismic activity. Securing of compressed gas containers, cylinders and tanks shall be by one of the following methods: Securing containers, cylinders and tanks to a fixed object with one or more restraints. Securing containers, cylinders and tanks on a cart or other mobile device designed for the movement of compressed gas containers, cylinders or tanks. Securing of compressed gas containers, cylinders and tanks to or within a rack, framework, cabinet or similar assembly designed for such use...”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 42929 Based on observations, interviews, and facility document review, it was determined the facility failed to ensure that eight (8) dialysis treatment chairs with torn and cracked upholstery were removed from use. Findings: On July 15, 2024 at 9:40 a.m, and July 16, 2024, at 1:46 PM, the surveyor observed seven (7) dialysis chairs in the dialysis waiting room and one (1) dialysis chair in the nursing facility hallway, all with worn, torn, taped, and cracked upholstery. The seven (7) chairs in the waiting room had signs indicating that the chair was not in use. The chair in the nursing facility hallway, had been used for dialysis patient treatments on July 15, 2024, and July 16, 2024. On July 15, 2024, at 10:32 AM the surveyor observed Staff Member #7 bring a dialysis chair in from the waiting area to station #2. The chair upholstery was ripped, torn, taped, and had cracks all over the chair. The surveyor observed what appeared to be blood on the inside and top of the left arm of the chair. Staff Member #7 stated the chair had been cleaned and that the red marks were a “stain” and not blood. The surveyor requested for the staff member to wipe the chair with a bleach wipe. Staff Member #7 wiped the arm of the chair and the red marks that were wiped, disappeared. There was still some blood on the top of the chair arm that the staff member did not wipe. Staff Member #7 placed a blanket on the chair and proceeded to place a patient in the chair and provide dialysis treatment in that chair. On July 15, 2024, Staff Member #11 indicated that the dialysis chairs in the waiting room were not supposed to be used, but sometimes they were needed for patient treatments. On July 16, 2024, Staff Member #4 confirmed that the dialysis chairs with torn and cracked upholstery should have been discarded but were sometimes required for patient treatments.”

“PR-PTS INFORMED OF RIGHTS WHEN BEGIN TX CFR(s): 494.70 The dialysis facility must inform patients (or their representatives) of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights. This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the facility failed to ensure each patient was informed of their rights when they began treatment in one (1) of four (4) medical records reviewed in the survey sample. Specifically, the facility failed to ensure that the representative for a patient who had been adjudged by the state court to lack legal capacity to make health care decisions was informed of the patient’s rights and was involved in healthcare decision making for that patient (Patient #3). Findings: The medical record for Patient #3 contained documentation from the county circuit court dated October 13, 2021 that the patient was “incapable of receiving and evaluating information effectively or responding to people, events, or environments to such an extent that they lack capacity to meet the essential requirements of their health, care, safety, or therapeutic needs without the assistance or protection of a guardian...” The document named Patient #3 as “legally disabled in all respects” and deemed the patient “mentally incompetent.” A guardian was appointed to consent to medical treatment for the patient. The medical record for Patient #3 was reviewed and contained Patient Rights documents and a document, Consent-Hemodialysis Treatment signed and dated by the patient on December 01, 2022. The documents were signed by the patient and not the patient’s guardian after they were found legally incapacitated and a guardian appointed to make health care decisions for the patient. The record contained no evidence that the patient’s rights or the risks and benefits of hemodialysis treatment were explained to the patient’s appointed representative prior to the patient beginning treatment. An interview was conducted with Staff Member #4 on July 16, 2024 who confirmed patient rights should be discussed with patient’s and/or their designated representative prior to treatment.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 36946 Based on interviews and document review, it was determined that the facility staff failed to ensure the Registered Nurse (RN) was notified of abnormal blood pressures in one (1) of four (4) medical records reviewed in the survey sample Medical record #4). Additionally, the facility failed to ensure each prescription for the dose of dialysis was signed by the physician in two (2) of four (4) medical records reviewed in the survey sample (Medical record #’s 2 and 4). The facility staff failed to weigh a patient post treatment for one (1) of two (2) patient’s observed. Findings: The medical record for Patient #4 contained documentation that the patient’s blood pressure dropped from 113/72 mmHg at 12:05 PM on July 01, 2024 to 95/51 mmHg at 12:35 PM on July 01, 2024 (greater than 20 mmHg decrease in diastolic blood pressure). There was no documentation in the record to indicate the RN was notified of the drop in blood pressure per the facility’s policy. The patient’s blood pressure again dropped from 117/59 mmHg at 1:35 PM on July 01, 2024 to 87/63 mmHg at 2:37 PM on July 01, 2024 (over 20 mmHg drop in systolic blood pressure). There was no notification to the RN of the drop in blood pressure. There was no documentation as to why monitoring did not occur every 30 minutes during this time period or that the RN was notified the patient’s blood pressure was not monitored in accordance with facility policy. On July 02, 2024, Patient #4’s blood pressure dropped from 123/54 mmHg at 1:07 PM to 93/53 mmHg at 1:40 PM (greater than 20 mmHg drop in systolic blood pressure), dropped again to 84/24 mmHg at 1:54 PM, and again to 69/47 mmHg at 1:56 PM. There was no documentation in the medical record that the RN was made aware of these blood pressures. On July 04, 2024, Patient # 4’s vital signs were documented at 12:28 PM and again at 1:36 PM, despite the facility’s policy mandating vital sign monitoring at least every 30 minutes. In an interview during record review on July 16, 2024, Staff Member #4 indicated the abnormal blood pressures should have been reported to the nurse and vital sign monitoring should be performed every 30 minutes. A review of the facility’s policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” states in part: ...Policy 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. ...b. At a minimum, obtain and document the following: i. Blood pressure 9. a. Vital signs and treatment monitoring...iii. Non-nocturnal treatments are completed at least every thirty (30) minutes. ...11. Abnormal findings or findings outside of any patient specific physician ordered parameter will be reported to the licensed nurse immediately (refer to Abnormal Findings section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician or (NPP if applicable) as needed of changes in patient status.. 16. If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 17. Licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility. Abnormal Findings ...Abnormal Findings Unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record. Within each category, definitions may be adjusted by a patient specific physician order. In addition, the teammate who is observing or collecting information should report to the licensed nurse whenever there is a concern for the patient’s condition or the potential safety of initiating dialysis, even in the absence of specific abnormal findings. Members of the patient care team should report ANY changes inpatient conditions or concerns of patient well-being immediately to the licensed nurse at any time... Blood Pressure-Intradialytic: Difference of 20 mm/Hg increase or decrease from patient’s last Intradialytic treatment BP reading.. The medical record for Patient #2 contained initial dialysis treatment orders signed by the nurse December 01, 2022. A box was checked indicating that the orders for treatment were verbal orders but the document did not contain the name of the ordering provider or the signature of the provider. The medical record for Patient #4 contained initial dialysis treatment orders signed by the nurse November 18, 2022.A box was checked indicating that the orders for treatment were verbal orders but the document did not contain the name of the ordering provider or the signature of the provider. An interview was conducted with Staff Member #4 on 07/18/24 who stated that verbal orders for initial dialysis treatments should be signed by the provider and acknowledged the lack of a provider signature on the orders. 42929 The facility’s policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” revised April 2024, states in part: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. a. Data collection includes but is not necessarily limited to: ... iv. Patient weight. ... Post Treatment Data Collection/Assessment 15. The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre-dialysis findings. ... Fluid Status: ... Post-treatment: If patient is above or below 1 kg from target weight ... On July 16, 2024, at 11:30 AM, the surveyor observed Staff Member #13 push the patient at station #6 in their dialysis chair from station #6 and out the treatment floor door after the patient’s treatment, without weighing the patient. The patient left the treatment floor in the dialysis chair. On July 16, 2024, at 12:40 PM, Staff Member #1 indicated that all patients get weighed on the facility scale after treatment and prior to leaving the facility. Staff Member #1 indicated that there is no other way to be weighed. During an interview on July 16, 2024, at 1:46 PM, Staff Member #9 indicated that the facility’s electronic medical record (EMR) allows the staff to push a button and the EMR will calculate the patient’s weight based on the pretreatment weight and the amount of fluid removed during treatment. Staff Member #9 indicated that the staff will use that calculated number instead of weighing the patient post treatment, but the staff is still supposed to weigh the patient post treatment.”

“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: 42929 Based on observation, interview, and facility document review, it was determined the facility staff failed to aseptically access the arteriovenous (AV) fistula for one (1) of one (1) patient observed. Findings: A review of the facility procedure, “AV FISTULA OR GRAFT CANNULATION WITH NIPRO OR MEDISYSTEMS SAFETY FISTULA NEEDLES (SFN) AND ADMINISTRATION OF HEPARIN LOADING DOSE,” revised October 2022, states in part: ... 11. While maintaining aseptic technique, cleanse the site by applying skin antiseptic using a circular rubbing motion, moving from the center out and allow to dry.... 13. Do not palpate insertion site once area has been prepped. Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation. ... On July 16, 2024, at 11:51 AM, Staff Member #7 palpated the AV fistula, then wiped the site for about two (2) seconds with an alcohol wipe, for both needle insertions. Staff Member #7 had difficulty getting blood return on the second needle and palpated the needle access multiple times after insertion and before covering with a dressing.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the facility failed to ensure each patients’ care plan was signed by the members of the interdisciplinary team in two (2) of four (4) medical records reviewed in the survey sample (Medical record #’s 1 and 4). Findings: The medical record for Patient #1 contained documentation that the patient’s first dialysis treatment was on April 23, 2024. The first care plan for the patient was developed June 18, 2024. The care plan did not contain any signatures to include the patient and the interdisciplinary team (IDT). The medical record for Patient #4 contained documentation of a care plan dated March 14, 2024. The care plan failed to contain the signature of the physician. The facility’s policy, Interdisciplinary team (IDT) patient assessment and plan of care was reviewed and reads in part: The patient’s plan of care will be completed by the facility’s interdisciplinary team, including patient or personal representative and be signed by team members including the patient or the patient’s personal representative. An interview was conducted with Staff Member #4 on July 16, 2024 who confirmed the plans of care should contain the signatures of the patient and members of the IDT.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the facility failed to ensure it implemented the initial plan of care within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session in two (2) of four (4) medical records reviewed in the survey sample (Medical record #’s 1 and 4). Findings: The medical record for Patient #1 contained documentation that the patient was admitted on April 23, 2024 The initial plan of care should have been completed by May 23, 2024. The initial care plan was not completed and implemented until June 18, 2024. During record review, Staff Member #4 confirmed that the care plan was completed late. The medical record for Patient #2 contained documentation that the patient was admitted on March 22, 2024 The initial plan of care should have been completed by April 21, 2024. The initial care plan was not completed and implemented until May 03, 2024. During record review, Staff Member #4 confirmed that the care plan was completed late. The facility’s policy Interdisciplinary Team (IDT) Assessment and Plan of Care was reviewed and reads in part: A comprehensive assessment will be conducted on all new patients within 30 calendar date (or 12 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the facility failed to ensure each patient was seen by the physician, nurse practitioner, clinical nurse specialist, or physician’s assistant at least monthly in two (2) of four (4) medical records reviewed in the survey sample (Patient #’s 3 and 4). Findings: The medical record for Patient #3 contained documentation that the patient was admitted December 01, 2022. The patient’s record contained no physician progress notes. The medical record for Patient #4 contained documentation that the patient was admitted October 26, 2022. The patient’s record contained no documentation of physician progress notes. An interview was conducted with Staff Member #4 on July 15, 2024 who confirmed the lack of progress notes for these two (2) patients. An interview was conducted with Staff Member #11(a Registered Nurse, RN) on July 16, 2024 who confirmed they had no access to physician progress notes for these patients. Staff Member #11 stated that a particular physician utilized a different electronic medical record software to document in and these notes were never incorporated into the dialysis record. An interview was conducted with the facility’s Medical Director on July 16, 2024 who stated that three (3) different physician groups round in the facility and they each use their own electronic medical record. The physician progress notes from two (2) of these groups are not incorporated into the facility’s medical record. The facility’s policy, Progress Note Policy was reviewed and reads in part: The attending nephrologist is required to record progress notes at least monthly and for any clinical event, which must be recorded in a timeframe that provides other interdisciplinary team members with an up-to-date picture of the status of the patient at all times.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the facility failed to ensure each adverse event was appropriately tracked and included in Quality Assessment Performance Improvement (QAPI) activities. Findings: The facility’s complaint log for the last twelve (12) months contained documentation on March 29, 2024 that Patient #5 spoke to the social worker regarding a complaint related to shortened treatment time. The social worker documented that the patient clotted on the machine resulting in shortened treatment time. The facility’s adverse event log was reviewed and it did not contain any documentation related to Patient #5 or the clotting event. An interview was conducted with Staff Member #11 on July 16, 2024 who indicated the clotting event should have been reported as an adverse event, but was not tracked or included in the adverse event reporting system. The facility’s policy, Risk Event Reporting Policy was reviewed and reads in part: Any unexpected event that is inconsistent with the routine operation of a dialysis facility, routine provision of acute dialysis or ancillary renal-related services may be a risk event. Such risk events include, but are not limited to, personal injury or potential personal injury to a patient or third party, property damage, theft equipment failure, flood, or “near miss” events...The teammate involved in the risk event or who witnessed the risk event firsthand will complete a Risk Event management (REM) Report.....Examples of reportable risk events...clotted access, clotted dialyzer.”

“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: 36946 Based on staff interview and document review, it was determined the facility failed to ensure its Quality Assessment Performance Improvement (QAPI) program developed recommendations and action plans to minimize infection prevention. Findings: The surveyors identified multiple infection control deficiencies that were cited at the condition level during the current survey. (Refer to V110). The surveyors requested to review the facility’s monthly infection control audits for the last six (6) months. On July 16, 2024, Staff Member #4 stated that the infection control audits were not done in January, April, May, June, or July and had only been completed in February and March for 2024. The surveyors requested to review the facility’s most recent quality improvement meeting minutes and data reviewed. Documentation indicated that the last quality improvement meeting was June 27, 2024 to review data from May 2024. Documentation indicted the covering Facility Administrator, Biomedical Technician, Social Worker, and Administrative Assistant attended the meeting. The Registered Dietician, Registered Nurse Clinical Coordinator, and the Medical Director did not attend the meeting. QAPI documentation indicated that the facility had an increased rate of bloodstream infections in May of 2024. The facility’s rate was documented as 3.37% and its goal was documented as 0.5%. There was no evidence that this was discussed in the QAPI meeting, that infections were analyzed or that an action plan to reduce the rate of bloodstream infections was developed or implemented. An interview was conducted with Staff Member #10 on July 16, 2024 who stated that improvement plans should be implemented monthly in every area that goals are not met. Staff Member #10 indicated that they were responsible for inputting the quality improvement plans, but they were only covering for this clinic and did not have access to the computer system necessary to complete the plans. The surveyors requested to see any documentation of an action plan developed in response to the bloodstream infection rate for May 2024 and no documentation was provided. Staff Member #10 indicated that the Medical Director was on vacation during the last quality improvement meeting, but they reviewed the data and signed off in July. Staff Member #10 confirmed there were not documented improvement plans when the Medical Director reviewed and signed off an the data presented in the quality meeting. The facility’s policy, Continuous Quality Improvement Program was reviewed and reads in part: Written documentation and plans of action will be documented within the FHM application known as Facility Health Record...Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as under performing will be reviewed to identify root causes for under performance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained.”

“MD RESP-QAPI PROGRAM CFR(s): 494.150(a) Medical director responsibilities include, but are not limited to, the following: (a) Quality assessment and performance improvement program. This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the facility’s medical director failed to make sure a Quality Assessment Performance Improvement (QAPI) plan was implemented to address areas where the facility is not meeting goals. Findings: The surveyors requested to review the agency’s most recent quality improvement meeting minutes and data reviewed. Documentation indicated that the last quality improvement meeting was June 27, 2024 to review data from May 2024. Documentation indicted the covering Facility Administrator, Biomedical Technician, Social Worker, and Administrative Assistant attended the meeting. The Registered Dietician, Registered Nurse Clinical Coordinator, and the Medical Director did not attend the meeting. QAPI documentation indicated that the facility was not meeting its goal for the following areas in May of 2024: Missed treatments, post weight above target weight, post weight below target weight, transplant waitlist, bloodstream infections, blood culture rates, low hemoglobin levels, albumin levels, phosphorus levels, corrected calcium levels, parathyroid hormone levels, uncorrected calcium levels, patients with a central venous catheter over 90 days, and AV fistula use. QAPI documentation contained no action plans developed in June 2024 to improve any of these items identified as under performing by the facility. An interview was conducted with Staff Member #10 on July 16, 2024 who stated that improvement plans should be implemented monthly in every area that goals are not met. Staff Member #10 indicated that they were responsible for inputting the quality improvement plans, but they were only covering for this clinic and did not have access to the computer system necessary to complete the plans. The surveyors requested to see any documentation of action plans, and none was provided. The facility’s policy, Continuous Quality Improvement Program was reviewed and reads in part: Written documentation and plans of action will be documented within the FHM application known as Facility Health Record...Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as under performing will be reviewed to identify root causes for nonperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained.”

“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: 42929 Based on observations, interviews, and facility document review, it was determined the facility staff failed to follow the facility’s policies and procedures related to post vascular access care for two (2) of two (2) patients observed. Findings: The facility’s policy titled “Post Dialysis Vascular Access Care: Fistula/Graft Using Safety Fistula Needles” revised April 2023, states in part: ... 5. Remove tape from one needle insertion site. Observe needle site for changes during treatment. Place gauze gently but firmly over needle insertion site. 6. Slightly remove needle and slide safety device in place. ... 13. Once bleeding has stopped, discard gauze or band-aid used to hold site. Inspect site for any trauma and for hemostasis. 14. Apply band-aid type or sterile dressing over cannulation site.... 15. ... For prolonged bleeding: refer to policy Prolonged Bleeding of Cannulation Sites... The facility’s policy titled “Prolonged Bleeding of Cannulation Sites” revised April 2023, states in part: ... 2. Prolonged bleeding of cannulation sites is defined as bleeding more than [thirty] 30 minutes post needle removal. ... 6. The licensed nurse checks for the presence of repeated cannulation to the same site and/or tear or trauma to the access site. Possible interventions may include: Direct manual pressure applied for [ten] 10 minutes with a clean gloved hand and sterile dressings used. Application of a sterile absorbable hemostatic sponge per physician’s order. Referral to physician for further intervention. NOTE: Only sterile absorbable hemostatic sponges are to be used on the cannulation site if needed for prolonged bleeding. Materials that are not approved for hemostatic use are not to be used.... On July 15, 2024, the surveyor observed both Staff Member #7 and Staff Member #8 place an iodine-soaked pad directly on the patient’s arteriovenous (AV) fistula after decannulation under the gauze dressing at the end of treatment for two separate patients. During an interview on July 15, 2024, at 2:01 PM, Staff Member #1 indicated that the staff placed the iodine-soaked pad directly on the AV fistula under the dressing “because the patient wanted it” and the patient gets “upset” if the staff doesn’t do it. Staff Member #1 indicated that the staff use the iodine-soaked pads because “it stops the bleeding quick”. Staff Member #1 confirmed that there was no order for using the iodine pad under the AV fistula dressing and the facility does not have a policy about it. During an interview on July 16, 2024, at 10:41 AM, Staff Member #11 indicated that the use of the iodine-soaked pads under the dressing on the AV fistula is not a facility policy. On July 16, 2024, at 1:12 PM, Staff Member #5 stated that the use of iodine-soaked pads under the dressing on the AV fistula was “news to me”. Staff Member #5 indicated that the staff should not be placing the iodine-soaked pads on the AV fistula under the dressing and there is no policy and no orders for that to be done.”

“MR-CENTRALIZE ALL INFO;IDT HAS ACCESS CFR(s): 494.170(b)(2) (2) All clinical information pertaining to a patient must be centralized in the patient’s record, including whether the patient has executed an advance directive. These records must be maintained in a manner such that each member of the interdisciplinary team has access to current information regarding the patient’s condition and prescribed treatment. This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the facility failed to ensure each patient’s clinical record contained all clinical information pertaining to the patient. Specifically, the facility failed to ensure it incorporated each physician progress note into the medical record in two (2) of four (4) medical records reviewed in the survey sample (Patient #’s 3 and 4). Findings: The medical record for Patient #3 contained documentation that the patient was admitted December 01, 2022. The patient’s record contained no physician progress notes. The medical record for Patient #4 contained documentation that the patient was admitted October 26, 2022. The patient’s record contained no documentation of physician progress notes. An interview was conducted with Staff Member #4 on July 15, 2024 who confirmed the lack of progress notes for these two (2) patients. An interview was conducted with Staff Member #11(Registered Nurse, RN) on July 16, 2024 who confirmed they had no access to physician progress notes for these patients. Staff Member #11 stated that a particular physician utilized a different electronic medical record software to document in and these notes were never incorporated into the dialysis record. The facility’s policy, Medical Records Documentation Guidance was reviewed and reads in part: The medical record refers to any document or electronic system used to record information regarding the patient’s diagnosis, treatment and care, including but not limited to:...progress notes. The facility’s policy, Progress Note Policy was reviewed and reads in part: Progress notes should be readily accessible to every authorized member of the healthcare team.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 36946 Based on staff interview and document review, it was determined the facility failed to ensure its internal grievance process was implemented in one (1) of three (3) patient complaints reviewed (Patient #6). Findings: Three (3) grievances received by the facility in the last twelve (12) months were reviewed. The complaint log contained an entry indicating that Patient #6 complained of the cleanliness of dialysis chairs on February 01, 2024. The complaint log contained no documentation that the Facility Administrator (FA) discussed the complaint with the patient, what the resolution of the complaint was, and if the patient was made aware of the investigation findings. The facility’s policy, Patient Grievance was reviewed and reads in part:The DaVita teammate should report the grievance to the charge nurse. If a solution to the grievance is not reached though this discussion, the charge nurse is to notify the FA and the Regional Operations Director within one business daft for follow up. The FA (or his/her designee) is to discuss the grievance with the patient, investigate and take appropriate action toward a solution if possible. This discussion should occur within 10 days of receipt of the grievance. An interview was conducted with Staff Member #10 on July 16, 2024 who confirmed the absence of documentation that the facility’s grievance process was followed for the complaint submitted by Patient #6.”