Davita Mt. Rainier Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 44367 Based on the overall findings of the survey, it was determined that the facility’s governing body failed to maintain an effective Infection Control Program, as evidenced by wide-spread non-compliance of the facility’s staff with the infection control standards and facility’s policies. The cummulative effect of these failures negatively impacted the quality of care in the facility and placed the facility patients and staff at potential risk for infections. The findings included: 1. The facility’s governing body failed to ensure that personal protective equipment (PPE)’s was worn in the treatment area where there was potential for contact with body fluids, hazardous chemicals, contaminated equipment, and environmental surfaces. Cross reference to tag V0115. 2. The facility’s governing body failed to ensure multiple patients’ medications were not taken to occupied stations. Cross reference to tag V0117. 3. The facility’s governing body failed to ensure that the clinical staff followed procedures a) when mixing Granuflo and b) when performing disinfection of the hemodialysis machines. Cross reference to tag V0122. 4. The facility’s governing body failed to ensure that the medications being administered to patients were handled aseptically. Cross reference to tag V0143. 5. The governing body failed to ensure that the clinical staff complied with the catheter care techniques outlined in the facility’s policies. Cross reference to tag V0147.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 44367 Based on the overall findings of this survey, it was determined that the facility’s governing body failed to maintain a safe and functional environment of care, as evident by failure of the facility staff to operate dialysis machines in accordance with the manufacturer’s instructions. These failure placed the affected patients at potential risk of serious injury, serious harm and possible death, and resulted in a finding that the facility was out of compliance with the Condition for Coverage: Physical Environment. The findings included: 1. Cross- reference to tag V0403: Physical Environment - Equipment Maintenance.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 44367 Based on the overall findings of the survey, it was determined that the facility’s Medical Director failed to provide an effective oversight of the patient care delivery and the staff’s compliance with the regulatory requirements and facility’s policies. This was evidenced by wide-spread non-compliance of the facility’s staff with the facility’s own policies and procedures and manufacturer’s instructions on assembly of dialysis machines and performance of safety checks prior to initiation of dialysis treatment. This failure placed the facility patients at potential risk of harm and injury. The findings include: 1) Responsibilities of the Medical Director - Ensure All Adhere to Policy and Procedure (V0715)”

“Policies/Procedures for Medical Documentation CFR(s): §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(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:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This Standard is not met as evidenced by: 44367 Based on observations, staff interview, and record review, the facility’s administration and the Medical Director failed to ensure that the patient’s health records remained confidential and protected from unauthorized access. This failure denied the patients their rights to privacy and confidentiality of their health information. Findings Included: Review on 08/19/2024 of the facility’s policy entitled “Facility Emergency Management Plan” determined that page 21 number 2 stated, “2. Digital and hard copy of patient medical records shall be secured at all times from unauthorized use.” Number 3 stated, “Health Insurance Portability and Accountability Act (HIPAA) policies will be followed to maintain patient privacy, policy access, use, and disclosure of protected health information.” On 08/19/2024 at 12:00 p.m., during the inspection of the Peritoneal Dialysis (PD) emergency equipment, the surveyor observed that the patient “Kardex” (patient treatment orders and medication list) binder was placed on top of the evacuation kit, making it accessible for unauthorized access. The Facility Administrator and the PD Nurse were informed of the findings on 08/19/2024.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility 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. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 44367 Based on observations, staff interviews, and record review, the facility’s administration and the Medical Director failed to confirm that Automated External Defibrillator (AED) was checked to ensure working condition and that supplies and medication were secured and non-expired. This failure placed the safety and well-being of the patients at potential risk of harm in the event of an emergency evacuation. Findings included: Review on 08/19/2024 of the facility’s policy 1-02-08 entitled “Emergency Equipment Checks” revealed that “daily checks should include ensuring that the facility’s AED is in working order as well as ensuring that the breakaway lock is intact; weekly checks should include ensuring adequate oxygen supply; and monthly checks should include ensuring supply expiration.” On 08/19/2024 Inspection of the Peritoneal Dialysis (PD) emergency equipment revealed the following: · The crash cart did have a breakaway lock in place, but the lock was already broken. · The emergency evacuation kit was not locked. · Two (2) Nasal Cannulas, lot number 1503676, expired 07/17/2024. On 08/21/2024, inspection of the in-center hemodialysis “Daily Zoll AED Log” revealed the following days that the AED was not checked: · 06/08/2024, 06/15/2024, 06/22/2024, 06/25/2024, 06/26/2024 and 06/29/2024; · 05/04/2024, 05/11/2024, 05/18/2024, and 05/25/2024; · 04/6/2024, 04/13/2024, 04/15/2024, 04/19/2024, 04/20/2024, 04/22/2024, 04/23/2024, 04/24/2024, and 04/26/2024. The Facility Administrator was informed of the findings on 08/20/2024 and 08/21/2024.”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 44367 Based on observation and review of the facility’s policies and procedures, the facility’s administration failed to ensure that the facility provided and maintained a safe treatment environment for its patients by ensuring the facility conducted fire drills quarterly per the facility’s policy. This failure placed the patients and visitors at potential risk of harm in the event of a fire. Findings included: Review on 08/22/2024 of the facility’s policy 4-07-01 “Facility Emergency Management Plan” revealed the following excerpt: “Fire safety drills: Required on a Quarterly basis.” During review of the emergency preparedness binder on 08/22/2024, the surveyor noted that the facility conducted a fire drill on 07/14/2022. There were no fire drills documented before or after 07/14/2022. The Facility Administrator was given the opportunity to provide additional documentation of fire drills; however, no additional documentation was provided. The Facility Administrator corroborated that the facility did not conduct fire drills quarterly as required per policy.”

“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: 44367 Based on observations and review of the facility’s policies, the governing body failed to ensure that personal protective equipment (PPE)’s was worn in the treatment area where there was potential for contact with body fluids, hazardous chemicals, contaminated equipment, and environmental surfaces. This failure posed a risk of exposure to infectious diseases and blood borne pathogens to other staff members, as well as patients. Staff: #5 Findings included: Personal protective equipment (PPE) is defined by the Occupational Safety and Health Administration (OSHA) as “specialized clothing or equipment, worn by an employee for protection against infectious materials.” Review on 08/20/2024 of the facility’s policy #1-05-05 “Infection Control” determined that page 3, #17 stated, “Physicians, nurse practitioners, social workers and dietitians will wear personal protective equipment (PPE) when in the treatment area. PPE is to be removed prior to leaving the treatment area.” During observation of the clinical treatment area on 08/20/2024 at 10:24 a.m., the surveyor noted that Staff #5 was standing in close proximity to the patient in Station #11 during the treatment termination process. Staff #5 did not have on a face shield or protective eyewear while speaking with the patient. The Facility Administrator was informed of the findings on 08/20/2024.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies, the governing body failed to ensure multiple patients’ medications were not taken to occupied stations. This failure posed a risk of exposure to infectious diseases and blood borne pathogens to patients. Staff: #1 Findings include: Review on 08/22/2024 of the facility’s policy 1-05-01 “Infection Control for Dialysis Facilities” determined that page 3 number 10 stated, “Unused supplies (syringes, alcohol swabs, tape, etc.) or medications (including multiple dose vials containing diluents) taken into the station should be used only for that patient and should not be returned to a common clean area or used on other patients.” Page 2 number 9 stated, “If a common supply cart is used to store clean supplies in the patient treatment area, this cart is to remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. The cart will not be moved between stations to distribute supplies.” Observation of the clinical treatment area on 08/22/2024 revealed that Staff #1 carried two cups of oral medication and two cups of water to occupied station #4 and placed one cup of water and one cup of medication on the chairside table. Staff #1 then carried the remaining cups to occupied Station #5 and placed the two cups on chairside table. The Clinical Specialist observed the findings with the surveyor and corroborated the findings.”

“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: 44367 Based on clinical observations, a review of the dialysis water room logs, a review of the facility’s policies and procedures, and interviews with the clinical and biomedical staff, the governing body failed to ensure that the clinical staff followed procedure 1) when mixing Granuflo and 2) during disinfection of the hemodialysis machines. This failure placed all patients at potential risk for exposure to blood-borne pathogens and infectious diseases. Findings included: 1) Review on 08/22/2024 of the facility’s “Granuflo (132 Gallon) Batch Record” revealed incomplete documentation for the mixing process of Granuflo Dry Acid. The missing documentation was as follows: · The batch was mixed on 07/22/2024. In the section of the document labeled “Part 2 number 3’, “Last Date 1 Micron Filter installed” field was blank. According to the procedure, the Micron Filter is to be replaced “after 6 batches.” Part 2 number 13, “Acceptable Specific Gravity Range: High” field was blank. The staff is to document the specific gravity low and high range. · The batch was mixed on 07/29/2024. In the section of the document labeled “Part 2 number 3”, “Last Date 1 Micron Filter installed” field was blank. The staff did not circle the number to indicate the current batch to alert when the filter needs to be replaced. Part 2 number 5, “Tank Fill Date/Time” field was blank. The date and time of fill are used to indicate and “Verify that the tank was empty at the start of dissolution cycle.” · The batch was mixed on 08/05/2024. In the section of the document labeled “Part 2 number 3”, “Last Date 1 Micron Filter installed” field was blank. · The batch was mixed on 08/12/2024. In the section of the document labeled “Part 2 number 3”, “Last Date 1 Micron Filter installed” field was blank. The staff did not circle the number to indicate the current batch to alert when the filter needs to be replaced. · The batch was mixed on 08/12/2024. In the section of the document labeled “Part 2 number 3”, “Last Date 1 Micron Filter installed” field was blank. The staff did not circle the number to indicate the current batch to alert when the filter needs to be replaced. The batch was mixed on 08/16/2024. In the section of the document labeled “Part 2 number 3”, “Last Date 1 Micron Filter installed” field was blank. The staff did not circle the number to indicate the current batch to alert when the filter needs to be replaced. In Part 2 number 5, “Tank Fill Date/Time” field was blank. 2) Review on 08/22/2024 of the dialysis machine manual “2008T Hemodialysis Machine Operator’s Manual” determined that page 189 stated, “The 2008T hemodialysis machine should undergo an acid cleaning daily when using bicarbonate concentrates during dialysis in addition to daily disinfection on treatment days. The purpose of the Acid & Heat Disinfection program... is to prevent the buildup of bicarbonates inside the machine that can have a detrimental effect on the machine’s performance and treatment efficacy and to then disinfect the machine. The entire Acid & Heat Disinfection program must be run in order to both clean and disinfect the machine.” Page 196 stated, “After a chemical disinfection cycle, the machine must be checked for residual disinfectant before initiating dialysis. A sample for testing for residual disinfectant can be obtained from a dialysate line or the drain line.” On 08/22/2024, interviews with the Facility Administrator and the Clinical Specialist revealed that the machines are supposed to be cleaned daily with heat and citric acid and that the machines are disinfected with bleach once a week on Sundays. The log did not reflect daily cleaning with citric acid and heat or a weekly disinfection with bleach. The surveyor requested additional proof of the daily and weekly bleach, however, no additional documentation was provided. The documentation for residual bleach checks were also requested as proof that machines were free of bleach prior to treatment in initiation. The surveyor asked the Facility Administrator if the machine tested for bleach prior to treatment initiation and the Facility Administrator was unable to provide an answer. Review on 08/22/2024 of the facility’s form “Dialysis Delivery System disinfection Log” from 01/01/2024 thru 08/21/2024 revealed lack of documentation to confirm that the staff cleaned the dialysis machines daily with citric acid and heat or weekly with bleach as required. The staff also did not document checks for residual bleach prior to treatment initiation. The facility had a total of 18 dialysis machines including two backup machines. The “Dialysis Delivery System Disinfection Log” revealed the following: · On 08/01/2024 thru 08/19/2024 and 08/21/2024, 18 out of 18 dialysis machines were not cleaned as required. · On 07/01/2024, 07/03/2024, 07/04/2024, 07/05/2024, 07/08/2024, 07/10/2024, 07/11/2024, 07/12/2024, 07/15/2024 and 07/17/2024 thru 07/31/2024, 18 out of 18 dialysis machines were not cleaned as required. · On 06/03/2024, 06/05/2024 thru 06/07/2024, 06/10/2024, 06/10/2024 thru 06/14/2024, 06/17/2024, 06/19/2024 thru 06/21/2024, 06/24/2024, and 06/26/2024 thru 06/28/2024, 18 out of 18 dialysis machines were not cleaned as required. · On 05/01/2024 thru 05/03/2024, 05/06/2024, 05/08/2024 thru 05/10/2024, 05/13/2024, 05/15/2024, 05/17/2024, 05/18/2024, 05/20/2024, 05/08/2024 thru 05/10/2024, 05/13/2024, 05/15/2024, 05/17/2024 thru 05/20/2024, 05/22/2024 thru 05/27/2024, and 05/29/2024 thru 05/31/2024, 18 out of 18 dialysis machines were not cleaned as required. · On 04/01/2024 thru 04/15/2024, 04/17/2024 thru 04/22/2024, and 04/24/2024 thru 04/29/2024, 18 out of 18 dialysis machines were not cleaned as required. · On 03/01/2024 thru 03/04/2024, 03/06/2024 thru 03/08/2024, 03/10/2024, 03/11/2024, 03/13/2024 thru 03/15/2024, 03/17/2024, 03/18/2024, 03/20/2024 thru 03/22/2024, 03/24/2024, 03/25/2024, and 03/27/2024 thru 03/31/2024, 18 out of 18 dialysis machines were not cleaned as required. · On 02/01/2024 thru 02/05/2024, 02/07/2024 thru 02/12/2024, 02/14/2024 thru 02/16/2024, 02/18/2024 thru 02/19/2024, 02/21/2024 thru 02/26/2024, 02/28/2024, and 02/29/2024, 18 out of 18 dialysis machines were not cleaned as required. · On 01/01/2024, 01/03/2024 thru 01/05/2024, 01/07/2024, 01/08/2024, 01/10/2024 thru 01/12/2024, 01/14/2024, 01/15/2024, 01/17/2024 thru 01/19/2024, 01/21/2024, 01/22/2024, 01/24/2024 thru 01/28/2024, and 01/31/2024, 18 out of 18 dialysis machines were not cleaned as required.”

“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: 44367 Based on clinical observations and interviews with the administrative staff, the facility’s governing body failed to ensure that the medications being administered to patients were handled aseptically. This failure placed the patients at potential risk of infection and cross contamination. Staff: #2 Findings include: Review on 08/20/2024 of the facility’s policy 1-06-01 entitled “Medication Policy” page 3 number 18, “An aseptic environment and aseptic technique is used when preparing medication.” Observation of the clinical treatment area on 08/20/2024 at 11:02 a.m. revealed Staff #2 punctured an open multi-dose Heparin vial without cleaning the septum. Staff #2 then drew Heparin up using three (3) syringes from the same vial and did not clean the septum before any of the medication drawings. The Facility Administrator was informed of the findings on 08/20/2024.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies and procedures, the governing body and the medical director failed to ensure that the clinical staff complied with the catheter care techniques outlined in the facility’s policies. This failure placed patients at potential risk of infection or harm in maintaining their central venous catheter. Staff: #3 and #6 Findings include: According to the National Institute of Health (NIH), “A central venous catheter (CVC) is an indwelling device inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium [parts of the heart].” Review on 08/20/2024 of the facility’s policy 1-04-02B “Central Venous Catheter (CVC) with Clearguard HD antimicrobial end caps” stated to “Perform a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines, such as during line reversal, or if the patient is disconnected during treatment for any reason.” The policy also stated, “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 15 seconds including the sides and the end of the hub thoroughly... “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 periphery ...Then wait 60 seconds for air dry time.” Review on 08/20/2024 of the facility’s policy 1-04-02B “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure” determined that page 3 number 1 stated, “Perform hand hygiene per procedure: Rationale: Hand hygiene protects patient and teammate from cross contamination.” Page 3 number 3 stated, “Re-perform hand hygiene per procedure and put on clean gloves.” Page 4 number 7 stated, “Remove gloves and discard. Perform hand hygiene per procedure and re-glove.” Page 5 number 10 stated, “Remove gloves and discard, perform hand hygiene per procedure and re-glove.” Page 5 number 14 stated, “Remove gloves and discard, perform hand hygiene per procedure and re-glove.” 1. During observation of the clinical treatment area on 08/20/2024 at 11:37 a.m., the surveyor noted that during treatment termination of a CVC patient at station #15, Staff #6 did not change gloves or perform hand hygiene per facility’s policy while accessing the patient’s CVC. Staff #6 removed both the arterial and the venous cap at the same time when disinfecting the catheter hubs. Staff #6 cleaned the insertion site from periphery to site (dirty to clean) rather that site to periphery (clean to dirty) and only allowed site to dry for 45 seconds before placing the new dressing. 2. During observation of the clinical treatment area on 08/22/2024 at 06:20 a.m., the surveyor noted that, during treatment initiation of a CVC patient at station #3, Staff #3 cleaned the insertion site from periphery to site rather that site to periphery. The patient’s mask did not cover their nose during the initiation process. The Clinical Specialist was informed of the findings on 08/20/2024 and 08/22/2024.”

“BACT OF H20-MEDICAL DIRECTOR RESPONSIBLE CFR(s): 494.40(a) 4.1.2 Bacteriology of water: med dir resp The facility medical director is responsible to ensure the manufacturer or supplier of a complete water treatment and distribution system demonstrates that the complete water treatment, storage, and distribution system is capable of meeting these requirements at the time of installation Following installation of a water treatment, storage, and distribution system, the user is responsible for continued monitoring of the water bacteriology of the system and for complying with the requirements of this standard, including those requirements related to action levels. This Standard is not met as evidenced by: 44367 Based on review of the Reverse Osmosis (RO) water, dialysate, and Hemodialysis (HD) machine culture logs, and interviews with the biomedical technician, the governing body and medical director failed to ensure that systems were continually monitored for bacteria colony forming units and endotoxins. This failure to provide oversight for the RO water, dialysate, and HD machine cultures placed the facility’s patients at risk of harm and potential exposure to infection. Findings included: Review on 08/19/2024 of the facility’s policy “AAMI Chemical Analysis of Water and Dialysis” determined that page 5 stated, “Medical Director must review and sign each chemical analysis report obtained during the review period.” Review on 08/19/2024 of the facility’s monthly RO water, dialysate, HD machine culture reports, and an interview with the Biomedical staff and the Facility Administrator revealed that the medical director did not sign and date (proof of acknowledging the culture collection results during the review period) reports from January 2024 and June 2024. The Biomedical Technician and the Facility Administrator corroborated that the culture reports were not signed by the medical director.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 44367 Based on observation and inspection of the water treatment system, the facility’s administration and the Medical Director failed to ensure that the clinical staff tested the water treatment system for chlorine according to facility’s policy. This failure placed the patients at potential risk of harm. Staff: #1 Findings include: Review on 08/20/2024 of the facility’s policy 1-18-05 “Total Chlorine test using RPC Ultra low Total Chlorine Test Strip” determined that page 1 stated, “ Remove one test strip from foil packet and dip it in the water sample for 60 seconds. While dipping the strip, move it back and forth at a constant rate of approximately two, 1-2 inch-wide strokes per second.” On 08/20/2024 at 01:38 p.m., the surveyor observed Staff #1 during the chlorine checks of the water system. Staff #1 dip the strip in the water sample and moved it back and forth for only 20 seconds. The Clinical Specialist was informed of the findings on 08/20/2024.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 44367 Based on observations and interviews with staff, the facility’s governing body failed to ensure the water treatment room was free from defects. This failure placed the patients, staff and visitors at potential risk of harm including injury or infection. Findings included: 1. Inspection of the water treatment room on 08/19/2024 revealed the following: · Gross amount of black, brown, and orange colored build up on the entire surface of the drain under the backflow preventer. · Gross amount of a white crystallization buildup on the top of acid dissolution tank (mix tank) and on the floor behind the tank. · Gross amount of white crystallization covering the ports on the floor attached to the two large acid holding tanks. 2. Inspection of the clinical treatment area on 08/19/2024 revealed the following: · Gross amount of white residue on the floor behind station #7. · White residue covering the entire surface on the lid of the red trash cans at station #7 and station #1. · An approximately 18 inch x 6 inch brown stain on the ceiling tile above the exit door next to station #9. The Facility Administrator was informed of the findings on 08/19/2024.”

“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: 44367 Based on observations, record reviews, and staff interviews, the facility’s governing body failed to ensure that the facility staff operated dialysis machines in accordance with the manufacturer’s recommendations and that the dialysis machines passed safety testing prior to initiating patient treatment. This failure placed the affected patient at potential risk of serious injury, serious harm, and possible death. Additionally, the facility staff failed to monitor the facility’s medication refrigerators in accordance with the facility’s policy. Patient: #10 Staff: #6 Findings included: a) On 08/21/2024 at 10:30 a.m., during review of the hemodialysis machine manual “2008T Hemodialysis Machine Operator’s Manual,” Chapter 3 “Starting Dialysis”, page 136 stated, “Verify that the venous line is in the venous clamp and the optical detector. Verify that the optical detector door is closed.” On 08/21/2024 at 10:23 a.m., during observations of the treatment floor, the surveyor observed that the optical detector door on machine #1 located at station #13 was partially open while Patient #10 was receiving treatment. At 10:23 a.m., Staff #6 corroborated that the optical detector door was partially open. At 10:23 a.m., the Clinical Specialist corroborated the observation and instructed Staff #6 to close the optical detector door after the surveyor informed them of the findings. Patient #10’s treatment was terminated 25 minutes after the finding. Due to the seriousness of the concerns that the facility staff failed to operate dialysis machines according to manufacturer’s recommendations, an immediate jeopardy (IJ) statement was issued at 2.30 pm on 08/21/2024 by the Office of Health Care Quality (OHCQ). On 8/22/2024 at 2.40 pm, the OHCQ survey team verified that the facility implemented an acceptable IJ removal plan, which included the following actions: 1. The Governing body held immediate in-service/re-education on 08/21/2024 on verification of optical detector door closure for all present clinical teammates responsible for machine set up and patient monitoring. 2. Reeducation of remaining teammates on machine set up and treatment monitoring tasks to be completed before the next shift. 3. Starting on 8/21/2024, a two-step verification process was implemented to ensure optical detector door is completely closed. 4. Starting on 08/21/2024, coaching and clinical oversight provided by Manager of Clinical Services, Clinical Coordinator and/or Qualified Clinical Leader to facility staff daily while observing machine set up for all machines. b) Review on 08/21/2024, of the policy 02-01-04 “Dialysis Delivery System Failures Occurring During Treatment” determined that page 3 stated, “Warning: If the dialysis delivery system fails any of the tests and the cause cannot be corrected, or if it fails subsequent tests, it should not be used for treatment. Remove the dialysis delivery system from service and have it inspected by a qualified Biomed teammate to correct the problem.” During observation of the clinical treatment area on 08/22/2024 at 04:03 p.m., the surveyor noted that machine #1 at Station #13 failed the initial tests (pressure and alarm) and Staff #6 retested for alarm test only. The Clinical Specialist was asked about the policy regarding machine test failures. The surveyor was informed that both the pressure and alarms tests were to be retested if either fails the first time. c) Review on 08/22/2024 of the facility’s policy 12-08-07 “Medication Requiring Refrigeration” revealed the following excerpt: “The refrigerator is checked, during facility normal operating hours, by a licensed nurse or teammate or designee...Twice daily temperature checks...at the beginning and end of the day.” Review on 08/22/2024 of the facility’s procedure 5-07-23A “Medication Refrigerator Temperature Log” revealed the following missing documentation: “ From 07/16/2024 thru 07/31/2024, there was no documentation for the beginning or the end of the day temperature. “ From 05/04/2024 thru 05/31/2024, there was no documentation for the beginning or the end of the day temperature. “ From 03/13/2024 thru 03/30/2024, there was no documentation for the beginning or the end of the day temperature. “ From 02/19/2024 thru 02/29/2024, there was no documentation for the beginning or the end of the day temperature.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 44367 Based on review of medical records, the Facility’s Administration and the Medical Director failed to ensure that initial nursing assessments were performed by the assigned registered nurse prior to a patient’s initial dialysis treatment when being admitted to the facility. This failure placed the affected patient(s) at risk for receiving insufficient and ineffective care and denied the patients their rights. Patient: #1, #2, #3, #4, #5, #7 and #9. Findings included: Review on 08/20/2024 of the facility’s policy 1-03-07 “New Patient Pre-Treatment Evaluation” revealed that “An RN, as required by federal regulation, will perform an initial pre-treatment evaluation of all new patients prior to the initiation of their first treatment at the facility.” Review on 08/20/2024 of the selected patients’ charts revealed that 7 out of 9 patients reviewed did not have an initial nursing assessment completed or the assessment was not completed at the time of admission. The surveyor noted the following: 1. Initial nursing assessment were not completed on Patients #1, #3, #4, #5, #7 and #9. 2. Patient #2’s assessment was completed on 08/23/2023, although Patient #2 was readmitted to the facility on 06/21/2024.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 44367 Based on review of the facility’s policy and dialysis patients’ treatment flowsheets, the facility’s administration and clinical staff failed to ensure that the dialysis prescriptions were followed as prescribed by the Nephrologist. This failure placed the patients at potential risk of harm and denied the patients their rights. Patients: #1, #3, #6 and #7. Findings included: The hemodialysis prescription includes the number of treatments per week, the length of treatment time, the dialyzer, the primary access being used for the patient; specific parameters of the dialysis delivery system, such as the blood flow rate (BFR), dialysate flow rate (DFR), and electrolyte composition of the dialysate; anticoagulation, and the patient’s target weight. Review on 08/20/2024 of the facility’s policy 1-03-08 “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” determined that page 4 number 10 stated, “If the dialysis prescription is not being met (including the inability to obtain prescribed blood flow rate or BFR) the reason will be documented, and the licensed nurse informed.” A review of the nine (9) selected patients’ treatment flowsheets on 08/20/2024 revealed that four (4) or 45% of the patients did not receive the correct dialysis prescription as ordered by the Nephrologist. 1. On treatment date 08/16/2024, Patient #1’s BFR was prescribed for 350 ml/min. however, the BFR was set at 300 ml/min from 07:02 a.m. to 10:57 a.m. There was no documentation from the clinical staff explaining why Patient #1’s BFR was not set on the dialysis machine as prescribed. 2. On treatment date 08/19/2024, Patient #3’s BFR was prescribed for 250 ml/min. however, BFR was set at 350 ml/min from 09:51 a.m. to 10:31 a.m. and then 300 ml/min from 11:31 a.m. to 01:31 p.m. There was no documentation from the clinical staff explaining why Patient #3’s BFR was not set on the dialysis machine as prescribed. 3. On treatment date 08/16/2024, Patient #3’s BFR was prescribed for 250 ml/min. however, the BFR was set at 350 ml/min from 10:34 a.m. to 02:04 p.m. There was no documentation from the clinical staff explaining why Patient #3’s BFR was not set on the dialysis machine as prescribed. 4. On treatment date 08/14/2024, Patient #3’s BFR was prescribed for 250 ml/min. however, the BFR was set at 350 ml/min from 11:01 a.m. to 02:01 p.m. There was no documentation from the clinical staff explaining why Patient #3’s BFR was not set on the dialysis machine as prescribed. 5. On treatment date 08/14/2024, Patient #6’s BFR was prescribed for 350 ml/min. however, BFR was set at 400 ml/min from 03:31 p.m. to 04:21 p.m. and then 300 ml/min from 5:31 p.m. to 06:31 p.m. There was no documentation from the clinical staff explaining why Patient #6’s BFR was not set on the dialysis machine as prescribed. 6. On treatment date 08/19/2024, Patient #7’s BFR was prescribed for 350 ml/min. however, BFR was set at 325 ml/min at 05:31 p.m. and then 300 ml/min from 06:01 p.m. to 06:32 p.m. There was no documentation from the clinical staff explaining why Patient #7’s BFR was not set on the dialysis machine as prescribed. The Facility Administrator was informed of the findings on 08/20/2024.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 44367 Based on the patients’ medical record reviews and interviews with the facility’s administration, the governing body and interdisciplinary team (IDT) failed to ensure that an initial comprehensive assessment and Plan of Care (POC) was completed for all new patients within the latter of 30 calendar days or 13 Hemodialysis sessions beginning with the first outpatient dialysis session. This failure placed the affected patients at potential risk of harm and denied patients their rights. Patients: #2, #3, #4, and #8. Findings included: Review on 08/21/2024 of the facility’s policy 1-14-01 “Patient Assessment and Plan of Care,” revealed that “A comprehensive assessment will be conducted on all patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.” Review on 08/21/2024 and 08/22/2024 of the facility’s medical records revealed that 4 out of the 9 selected patients did not have an initial (30-day) assessment completed. Patient #2 was admitted on 06/01/2024. No 30-day assessment was found in Patient #2’s paper or electronic chart. Patient #3 was admitted on 07/10/2024. No 30-day assessment was found in Patient #3’s paper or electronic chart. Patient #4 was admitted on 05/24/2024. No 30-day assessment was found in Patient #4’s paper or electronic chart. Patient #8 was admitted on 09/04/2020. No 30-day assessment was found in Patient #8’s paper or electronic chart. The Facility Administrator was informed of the findings on 08/21/2024 and 08/22/2024.”

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 44367 Based on the patients’ medical record reviews and interviews with the facility’s administration, the governing body and interdisciplinary team (IDT) failed to ensure that a 3 month (90-day) comprehensive assessment and Plan of Care (PoC) was completed 3 months after the completion of the initial (30-day) comprehensive assessment and PoC. This failure placed the affected patients at potential risk of harm and denied patients their rights to effective care. Patients: #8 Findings included: Review on 08/20/2024 of the facility’s policy 1-14-01 “Patient Assessment and Plan of Care” revealed the following excerpt, “A follow-up 90-day reassessment will be completed to evaluate the patient’s status and provide information to adjust the patient’s plan of care.” Review on 08/20/2024 of the facility’s medical records revealed that 1 out of the 9 of the selected patients did not have a 90-day assessment completed. Patient #8 was admitted on 09/04/2020. No 90-day assessment was found in Patient #8’s paper or electronic chart. The Facility Administrator was informed of the findings on 08/20/2024.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies and procedures, the facility’s administration and the Medical Director failed to ensure that the clinical staff followed the facility’s infection control policy and procedure when accessing a patient’s vascular access. This failure placed the safety and well-being of the patients at potential risk of infection and maintaining their vascular access. Staff: #4 Findings included: Review on 08/20/2024 of the facility’s policy “Cannulation of Fistula or Graft”, Procedure 01-04-01E, determined that page 3 #13 stated: “Do not palpate insertion site once area has been prepped. Rationale: Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.” During observation of the clinical treatment area on 08/20/2024 at 11:19 a.m., the surveyors noted that during treatment initiation at station 5, Staff #4 cleaned the patient’s access and then palpated the access prior to cannulation. Staff #4 did not re-clean the access prior to cannulation. The Clinical Specialist was informed of the findings on 08/20/2024.”

“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: 44367 Based on review of the Peritoneal Dialysis (PD) Quality Assessment and Performance Improvement (QAPI) meeting minutes and data, and review of the agency’s policies and procedures, the governing body and the Medical Director failed to ensure the facility’s interdisciplinary team (IDT) adjusted action plans related to Peritonitis when goals were not being met. This failure denied patient effective and safe dialysis which placed the patients at risk for harm and/or death. Findings included: Review on 08/22/2024 of the facility’s policy 1-14-06 “Continuous Quality Improvement Program” revealed the following excerpt: “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not limited to, the following: Infection Control, including incidence of infections, Vascular access, Mortality Review - review of deaths, Hospitalizations and Emergency Ambulance Transfers.” Additionally, page 2 number 8 of the policy stated, “Continuous monitoring of above indicators will be reflected in the meeting minutes, Any area identified as underperforming will be reviewed to identify root cause for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvement and sustained.” Number 9 of the policy stated, “Each action plan will be evaluated as priority with Patient Safety and Clinical Outcomes indicators for the highest priority.” On 08/22/2024, during review of the Peritoneal Dialysis Quality Assessment and Performance Improvement (QAPI) meeting minutes from February 2024 through July 2024, the surveyor noted that the facility did not adjust the goal for the Peritonitis rate. Despite not making goal, the facility did not make adjustments to the action and intervention plan for the “Peritonitis Rate” from February 2024 through July 2024 or performed a review to identify the root cause for underperformance. The documentation did not change from February 2024 through July 2024. The documentation was as follows: · Section labeled Process Improvement Goals from 02/2024 - 07/2024 stated: “Plan to have patients demonstrate how they perform treatments at home during a technique review.” · Section labeled “Process Deep Dive” from 02/2024 - 07/2024 stated: “The patient that continues to have reoccurring peritonitis and has been giving education on infection control. Home visit completed and modality option education.” · Section labeled “Action(s) and Interventions from 02/2024 - 07/2024 stated: “ RN will request IDT meeting to address the patient with reoccurring peritonitis.” · Section labeled “ IP Evaluation Plan from 02/2024 - 07/2024 stated: “ Percentage of patients without peritonitis goal will increase within 30 days.” On 08/22/2024, the Facility Administrator corroborated that the documentation for peritonitis was not adjusted despite the facility’s Peritonitis rate.”

“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: 44367 Based on observations, staff interviews and review of the facility’s policies and procedures, the Medical Director failed to ensure that the facility’s staff members adhered to their own policies and procedures and to ensure the facility was effectively governed. This failure posed a potential risk of safety to the patients, and denied patients their rights to a minimum standard of medical care. Findings included: 1. On 08/19/2024 and 08/22/2024, inspection of the in-center hemodialysis and the peritoneal dialysis emergency evacuation kit and crash cart revealed that patients information was exposed allowing unauthorized access. Inspection of the emergency preparedness binder revealed that the facility did not conduct quarterly fire drills. These findings failed to meet the facility’s policy “Facility Emergency Management Plan.” Cross-referenced with tags E0023 and E0036. 2. On 08/19/2024, inspection of the in-center and peritoneal dialysis emergency evacuation kit and crash cart revealed that the Automatic External Defibrillator (AED) was not inspected daily, expired supplies, and both evacuation kit and crash cart were unsecured. These findings failed to meet the facility’s policy “Emergency Equipment Checks.” Cross-referenced with tag E0028. 3. On 08/20/2024 and 08/22/2024, observation of the clinical treatment area revealed Staff #5 did not wear protective eyewear during the treatment termination process and Staff #3 carried multiple patients’ medication and water to an occupied station. These findings failed to meet the facility’s policy titled “Infection Control for Dialysis Facilities.” Cross-referenced with tag V0115 and V0117. 4. On 08/22/2024, inspection of the water room documentation revealed that the staff did not document completely for the Granuflo Dry Acid mixing process. The finding failed to meet the facility’s policy “Granuflo (132 Gallon) Batch Record.” Cross-reference with tag V0122. 5. On 08/20/2024, observation of the clinical treatment area revealed Staff #2 did not clean the septum of a multi-dose vial of Heparin prior to puncturing to draw up the medication. The finding failed to meet the facility’s policy “Medication Policy.” Cross-referenced with tag V0143. 6. On 08/20/2024 and 08/22/2024, observation of the clinical treatment area revealed that Staff #3 and Staff #6 did not provide appropriate catheter care techniques and procedures when initiating treatment. This finding failed to meet the facility’s policy “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps.” Cross-referenced with tag V0147. 7. On 08/19/2024, inspection of the water system and the hemodialysis machines revealed that the Medical Director did not sign the cultures results, providing review and acknowledgement of the results for January 2024 through June 2024. This finding failed to meet the facility’s policy “AAMI Chemical Analysis of Water and Dialysis.” Cross-referenced with tag V0179. 8. On 08/20/2024, inspection of the water treatment room revealed that Staff #1 did not correctly check the chlorine levels in the water system. This finding failed to meet the facility’s policy “Total Chlorine test using RPC Ultra low Total Chlorine Test Strip.” Cross-referenced with tag V0196. 9. On 08/21/2024 and 08/22/2024, observation of the clinical treatment area revealed Patient #10 machine’s air detector was partially open while the patient was receiving treatment and Staff #6 did not test the machine according to the manufactures recommendation; and the medication refrigerator was not checked per policy. These findings failed to meet the facility’s policies “Dialysis Delivery System Failures Occurring During Treatment” and “Medication Requiring Refrigeration.” Cross-referenced with tag V0403. 10. On 08/20/2024, inspection of patients’ charts revealed that 7 out of the 9 selected patients did not have an initial nursing assessment completed on admission. The findings failed to meet the facility’s policy “New Patient Pre-Treatment Evaluation.” Cross-referenced with tag V0502. 11. On 08/20/2024, review of patient’s flowsheets revealed that 4 out of 9 of the selected patients did not receive their dialysis treatment as prescribed by the Nephrologist. This finding failed to meet the facility’s policy “Pre-Intra-Post Treatment Data Collection.” Cross-referenced with tag V0503. 12. On 08/21/2024, review of the selected patients’ comprehensive assessments revealed that 2 out of the 9 patients did not have 30-day assessment and 1 out of 9 patients did not have a 90 -day assessment completed. These findings failed to meet the facility’s policy “Patient Assessment and Plan of Care.” Cross-referenced with tag V0516 and V0517. 13. On 08/20/2024, observation of the clinical treatment area revealed Staff #4 did not follow infection control procedure when accessing patients’ vascular access. This finding failed to meet the facility’s policy “Cannulation of Fistula or Graft.” Cross-referenced with tag V0550. 14. On 08/22/2024, review of the Peritoneal Dialysis (PD) Quality Assessment and Performance Improvement (QAPI) meeting minutes and data revealed that from “February 2024 through July 2024 the facility did not make adjustments to the goal, action plan, or conduct an analysis to decrease the incidents of Peritonitis. This finding failed to meet the facility’s policy “Continuous Quality Improvement Program.” Cross-referenced with tag V0637. 15. On 08/21/2024 and 08/22/2024, review of patient charts revealed that incomplete consent forms were found in Patient #1 and Patient #9 charts. This finding failed to meet the facility’s policy “Medical records Documentation Guidance.” Cross-referenced with tag V0726.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 44367 Based on medical record review, the facility administrator and medical director failed to ensure that all of the facility’s patient’s medical records were complete and accurate. This failure denied the patients their rights to formulate their own treatment decisions. Patients: #1 and #9 Findings included: Review on 08/20/2024 review of the facility’s policy 3-02-02 “Medical records Documentation Guidance” revealed the following excerpt: “All handwritten entries must be legible in the medical record...Do not chart in advance (before the service, observation or order)...Document accurately and concisely but completely.” Review on 08/20/2024 of Patient #9’s chart revealed that the MOLST form was incomplete. The form did not have a legible “Practitioner’s Signature” (the signature resembled one letter), did not have a “Printed Practitioner’s Name, a Maryland License number, or a Practitioner’s phone number. Review on 08/22/2024 of Patient #1’s chart revealed the patient was admitted to the facility on 07/30/2024. On 07/30/2024, Patient #1 signed and dated a “Consent - Hepatitis B Vaccine” and “Pneumococcal Conjugate (PCV20) Vaccine (Prevnar 20) Patient Consent Form”; however, the forms were completely blank. The forms were only signed and dated by Patient #1.”