Bma - Bethesda

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 44367 Based on the findings of the survey, it was determined that the facility’s administration and the Medical Director failed to maintain a safe physical environment and ensure that patients received their dialysis treatment on a dialysis machine that was assembled per manufacturer ’ s instructions prior to initiating safety checks. This failure placed all patients at increased risk for harm and/or death and resulted in a finding of the facility being out of compliance with the Condition for Coverage for Physical Environment. The findings include: 1. Physical Environment - Equipment Maintenance (tag V0403)”

“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 effective oversight of the facility and ensure that the facility’s staff adhered to the facility’s own policies and procedures before, during, and after provision of dialysis treatment. Multiple instances of staff not following the facility procedures were identified during this survey, including a deficient practice of initiating safety testing of dialysis machines without machines being properly assembled in accordance with the manufacturer’s instructions. This systematic failure created an unsafe environment of care and placed all patients at an increased risk for harm. As a result, the facility was found to be out of compliance with the Condition for Coverage - Responsibilities of the Medical Director. The findings include: 1) Responsibilities of the Medical Director - Ensure All Adhere to Policy and Procedure (tag V0710)”

“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 and interviews with facility staff and the governing body, the facility’s administration failed to ensure that all required emergency supplies were readily available in the event of an emergency. This failure placed patients at potential risk of harm and danger during a life threatening situation. Finding includes: Review on 06/17/2024 of the facility’s policy FMC-CS-IC-II-130-007A “Emergency Medications, Equipment and Supplies” determined that: “Emergency supplies must be contained in a box or cart that is locked and is equipped with a dedicated oxygen tank.” Review on 06/17/2024 of the facility’s policy FMC-CS-IC-II-130-007A “Emergency Medications, Equipment and Supplies” revealed that: “An itemized log must be kept indicating the contents and expiration date of contents. Items approaching expiration must be reordered and replaced prior to the actual expiration date.” Inspection of the facility’s emergency equipment on 06/17/2024 at 10:30 a.m. revealed the following: 1. The crash cart was not locked and not secured. 2. The evacuation kit had two 1000 ml bags of 0.9% Sodium Chloride, lot number 23DU06040, expired 04/2024. The Clinical Manager was informed of the findings on 06/17/2024.”

“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: 44367 Based on clinical observations, the facility’s administration failed to ensure that the standards of care related to hand hygiene and glove use requirements were followed by all staff who came in contact with the dialysis patients in the facility. This failure placed the patients and staff at potential risk for nosocomial infections (infections acquired while in a healthcare setting). Staff: #2 and #5 Findings included: According to the Centers for Disease Control and Prevention (CDC), infection can be spread in a dialysis center through the passing of microorganisms from one patient to another by the hands of the caregiver; or if the environmental surfaces are contaminated and touched by a caregiver or patient. Even with glove use, hand hygiene is necessary before gloves are put on and after gloves are removed because hands can become contaminated through small defects in gloves and from the outer surface of the gloves during glove removal. Review on 06/12/2024 of the facility’s policy “Personal Protective Equipment”, page 2 revealed the following excerpt, “Change gloves and practice hand hygiene between each patient and/or station to prevent cross contamination.” During observations of the clinical treatment area on 06/12/2024 and 06/14/2024, the surveyor noted the following: On 6/12/2024 at 11:55 a.m., Staff #2 was terminating treatment of the patient at station #16. Staff #2 left station #16 with the same gloves and went to the medication area to get clean supplies and returned to station #16. Staff #2 did not remove dirty gloves and did not perform hand hygiene. On 06/13/2024 at 11:20 a.m., Staff #5 provided assistance to the patient at station 11, removed gloves, and did not perform hand hygiene before gathering supplies from the clean supply cart. Staff #5 then placed clean gloves without conducting hand hygiene and started the process of terminating a central venous catheter (CVC) patient at station #10.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 44367 Based on infection control observations, the Clinical Manager and Medical Director failed to ensure that the clinical staff followed safe practices when handling infectious wastes. This failure created a potential risk of blood exposure and risk of harm to patients and staff in the unit. Staff: #5, #6, and #8 Findings include: The regulation of Occupational Health and Safety Administration (OSHA) at 29 CFR 1910.1030(d)(2)(xi) states: All procedures involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering and generation of droplets of these substances. Carrying contaminated blood tubing, used needles, syringes and dialyzer from the patient’s station across the treatment floor to a biohazard box, or sharps container could result in unknown spattering of blood. During observations of the clinical treatment area on 06/12/2024 at 11:42 a.m., Staff #5 removed bloody lines and dialyzer from station #4 and walked across occupied station #5 to dispose in the Biohazardous waste bin. During observations of the clinical treatment area on 06/12/2024 at 11:51 a.m., Staff #6 removed bloody lines and dialyzer from station #4 and walked across occupied station #5 to dispose in the Biohazardous waste bin. During observations on the clinical treatment area on 06/13/2024 at 11:07 a.m., Staff #8 removed bloody lines and dialyzer from station #4 and walked across occupied stations #5 and #6 to dispose in the Biohazardous waste bin in front of station #11. Clinical Manager was informed of the findings on 06/12/224 and 06/13/2024.”

“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: 44367 Based on clinical observations, the governing body failed to ensure that the clinical staff followed the standard procedures in the cleaning and disinfection of contaminated equipment being used in the facility. This failure put patients at risk for possible cross-contamination. Staff: #5, #6, and #7 Findings included: Review on 06/12/2024 of the facility’s policy “Prime Bucket Disinfection” revealed the following excerpt: “Clean all surfaces of the prime bucket or approved receptacle, with 1:100 bleach solution or an approved 1:100 bleach disinfect wipe.” During observations of care on 06/12/2024 at 11:36 a.m., Staff #7 did not clean the prime bucket during the machine disinfection process at station #11. During observations of care on 06/12/2024 at 11:41 a.m., Staff #5 did not clean the prime bucket during the machine disinfection process at station #7. During observations of care on 06/12/2024 at 11:47 a.m., Staff #6 did not clean the prime bucket during the machine disinfection process at station #5. The Clinical Manager was informed of the findings on 06/12/2024.”

“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 appropriate catheter care techniques and procedures. This failure placed patients at potential risk of infection or harm in maintaining their central venous catheter. Staff: #5 and #7 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 06/12/2024 of the facility’s policy “Changing the Catheter Dressing Procedure,” page 2, revealed the following excerpt: “2% Chlorhexidine and 70% alcohol: Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward 2 inches in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds.” Review on 06/12/2024 of the facility’s policy “Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer,” page 4, revealed: “Threads and end of the luer lock (hub) must be scrubbed with 70% sterile alcohol pad (or other antiseptic such as chlorhexidine, povidone if required by the hospital) for 10-15 seconds and any time caps are removed, or bloodlines are disconnected (i.e. end of treatment or treatment interruption) to reduce risk of contamination.” During observation of the clinical treatment area on 06/12/2024 at 11:24 a.m. at station #10, the surveyor noted that Staff #5 cleaned the exit site for twenty-two (22) seconds. Staff #5 cleaned the venous hub for one (1) second and cleaned the arterial hub for one (1) second. During observation of the clinical treatment area on 06/12/2024 at 12:06 p.m. at station #9, the surveyor noted that Staff #7 cleaned the venous hub for six (6) seconds and cleaned the arterial hub for six (6) seconds. During observation of the clinical treatment area on 06/14/2024 at 15:35 a.m. at station #9, the surveyor noted that Staff #5 cleaned the venous hub for six (6) seconds and cleaned the arterial hub for three (3) seconds. The Clinical Manager was informed of the findings on 06/12/2024 and 06/14/2024.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 44367 Based on observations of the environment of care, the Facility’s Administration and the Medical Director failed to ensure that the water room remained secured and restricted from unauthorized access. This failure placed the patients and staff at potential risk of harm. Findings included: 1.On 6/12/2024 at 10:00 a.m., during inspection of the water room, the surveyors observed that the door was not locked and was easily accessible to unauthorized persons. 2. On 06/12/2024 at 10:20 a.m., during the flash tour, the surveyors observed that the water room door was open despite have a coded lock in place, making the water room easily accessible to unauthorized persons. 3. On 6/13/2024 at 10:30 a.m., during inspection of the water room, the surveyors observed that the door was not locked and was easily accessible to unauthorized persons. 4. On 06/14/2024 at 06:00 a.m., during inspection of the water room, the surveyors observed that the door was not locked and was easily accessible to unauthorized persons. The Clinical Manager was informed of the findings on 06/12/2024, 06/13/2024, and 06/14/2024 of the findings.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 44367 Based on observations of the facility’s bicarbonate tank and a review of the facility’s policies and procedures, the facility’s administration and the medical director failed to ensure that the bicarbonate tank’s contents were labeled correctly. This failure placed the patients at potential risk for harm. Findings include: Review on 06/12/2024 of the facility’s policy “Concentrate Labeling requirements,” page 2, revealed, “Mix tank labeling must include: Contents identification. For example , “Bicarb”, “Acid”, “RO Water” or Disinfectant”...Date time of mixing.” On 06/12/2024, observation of the facility’s water treatment room revealed the following: 1. The tank labeled “Bicarb Mix” had 30 gallons of clear liquid, but the tank did not have a date and time. 2. The Dissolution tank was filled with clear liquid to the line marked, “Final fill.” The tank was labeled “Mixed by CC 3/21/2023 4:40 pm.” The Clinical Manager and the Biomedical Technician were informed and observed the findings.”

“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 the facility’s administration, the governing body failed to ensure that the physical structure of the dialysis facility and the water treatment room was kept intact and obstacle free at all times. This failure placed the patients, staff and visitors at potential risk of harm including exposure to hazardous or infectious material from a potentially contaminated water system. Findings included: On 06/12/2024 at 11:30 a.m., inspection of the clinical treatment area and the water treatment room revealed the following: 1. At the base of the wall behind station #11, there were large gaps causing the contents of the wall to be exposed and seeping out, creating a non-intact surface. 2. At the base of the wall between station #17 and station #18, there were large gaps causing the contents of the wall to be exposed and seeping out, creating a non-intact surface. 3. Large 3-tier cart with multiple boxes was blocking the hot water tank access in the water treatment room. 4. Large trash can was blocking sediment filter of the water treatment system. 5. Two large 4-tier carts with multiple boxes of assorted supplies were blocking the backflow, preventer, temperature valve, main RO system box, expansion tank, booster pump and multiple gauges, and valves of the water treatment system. 6. Drain between the primary carbon tank and the multimedia tank filter had a gross amount of orange, brown, and black stains on its surface. The Director of Operations and the Biomedical Technician were informed and observed the findings on 06/12/2024.”

“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 1) failed to ensure that the facility staff assembled and operated dialysis machines in accordance with the manufacturer’s instructions prior to safety testing, and 2) failed to ensure all dialysis supplies were non-expired. This failure placed patients a risk for harm and/or death. Staff: #1, #2, #3, #4 and #9 Finding Include: Review on 06/13/2024 of the facility’s policy “Priming an Optiflux Single Use E-Beam Dialyzer,” page 5 number 13 revealed, “ Place venous bloodline in the occluding clamp below the air detector and close optical detector door beneath occlusion clamp.” Review on 06/13/2024 of the facility’s policy “Priming an Optiflux Single Use E-Beam Dialyzer,” page 5 number 14 revealed, “If the AUTOMATIC TESTING FAILS, repeat the test. If the cause of the failure cannot be corrected, or if it fails subsequent tests, the machine should not be used.” On 06/13/2024 at 04:20 p.m., during review of the Fresenius 2008T Machine Operator’s Manual, page 63 stated: “Warning! The tubing beneath the venous drip chamber must be inserted into the venous line clamp and the optical detector.” On 06/13/2024, during observations of the treatment floor, the surveyor observed the following: · At 10:37 a.m., Staff #1 tested dialysis machine #8 located in Station #3 without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector). · At 10:38 a.m., Staff #2 tested dialysis machine #14 located in Station #15 without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector). · At 10:38 a.m., the Clinical Manager (CM) was informed of the findings and the safety issue. CM corroborated that the machines were not assembled per manufacturer instructions prior to safety testing. The Clinical Manager instructed Staff #1 and Staff #2 to retest machines #8 and #14 after the surveyor intervened. CM informed the surveyor that the staff would be educated immediately and at 10:40 a.m., the surveyor observed that the Clinical Manager called a meeting with the staff. · At 11:28 a.m., Staff #3 tested dialysis machine #20 located in Station #13 without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector). · At 11:30 a.m., Staff #4 tested dialysis machine #4 located in Station #8 without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector). Staff #4 initiated the patient’s treatment without retesting. · At 11:32 a.m., the Regional Director and Clinical Manager corroborated that machines were not assembled or tested in accordance with manufacturer’s instructions. On 06/14/2024, during observations of the treatment floor, the surveyor observed the following: · At 07:19 a.m., machine #22 at station #17 failed the automatic testing, which consisted of two test (alarm test and pressure test). Staff #9 retested the alarm portion of the test instead of retesting both. The surveyor asked the clinical educator if one or both tests are required to retest when the automatic testing fails. The clinical educator corroborated that both test are to be retested. Staff #9 did retest machine #22 after the surveyor’s intervention. The facility’s practice of initiating the required safety testing while elements of the machine were not assembled according to manufacturer instructions placed the affected patients at risk of serious injury, serious harm, and possible death. Due to the seriousness of the concern that the facility staff failed to operate dialysis machines according to manufacturer’s recommendations, an immediate jeopardy (IJ) statement was issued to the facility at 1.30 p.m. on 06/13/2024, by the Office of Health Care Quality (OHCQ). On 06/14/2024 at 6.09 p.m., the OHCQ survey team verified that the facility implemented an acceptable IJ removal plan which included the following steps: 1. On 6/14/24, facility provided education to all direct patient care (DPC) staff on the facility policies, “FMS-CS- IC-I-105- 005C Priming an Optiflux® Single Use Ebeam Procedure” and “FMS-CS-IC-I-110-141C Pre-Treatment Safety Checks Procedure,” with specific emphasis on ensuring the venous line is inserted into the occlusion clamp prior to machine testing. Staff not present on 06/14/24 will receive education during the next shift and prior to initiating machine set up. 2. On 6/14/24, facility educated its nursing staff and implemented an auditing procedure requiring a registered nurse to verify that every machine, every shift, was set up with the venous line in the occlusion clamp prior to initiation of testing per policy and to address any staff non-compliance with immediate progressive discipline. The results of verification were reported to the Clinical Manager to be transcribed into the Electronic Auditing Tool. 3. On 06/14/24, the Clinical Manager began conducting staff meetings prior to the 1st shift and after the last shift to discuss results of the daily audit. 2) Observation of the supply room on 06/12//2024 at 1:00 p.m. revealed the following expired supplies: · Three (3) bottles of TDS/Conductivity Standard Solution, lot number 022136JS, expired 03/03/2024; · Three (3) bottles of TDS/Conductivity Standard Solution, lot number 021032AR, expired 03/03/2024; · Four (4) Optiflux F200 NR Dialyzers, lot number 21EU04019, expired 05/31/2024. Observation of the clinical treatment area on 06/12//2024 at 1:40 p.m. revealed the following expired supplies: · One (1) bottle of Liquacel 32 ounces, lot number G056A, expired 02/2024; · Seven (7) AV Fistula Needle Sets, lot number 180701381, expired 07/01/2023. The Clinical Manager and the Director of Operations were informed and observed the findings on 06/12/2024, 06/13/2024 and 06/14/2024.”

“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 and interviews with the facility’s administrative staff, the governing body failed to ensure that the assigned registered nurse (RN) performed initial nursing assessments prior to the patients’ initial dialysis treatment when being admitted to the facility. This failure placed the affected patients at risk for receiving insufficient and ineffective care and denied the patients their rights. Patients: #1, #2, #3, #4, #5, and #6 Findings included: Review on 06/17/2024 of the facility’s policy “Comprehensive Interdisciplinary Assessment and Plan of Care,” revealed: “A registered nurse must perform an assessment on patient new to dialysis before initiation of their first treatment to determine immediate needs.” During a review of six (6) selected patient medical records on 06/17/2024, the surveyor noted that six (6) out of the six (6) or 100% of the selected patient paper or electronic charts did not contain an initial nursing assessment. The assessment should have been completed prior to the patient being placed on the dialysis machine on the day of admission. The Clinical Manager was given the opportunity to provide the missing initial nursing assessments; however, the Clinical Manager corroborated that the initial nursing assessments were not completed.”

“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 dialysis patients’ treatment flowsheets, the facility’s administration and clinical staff failed to ensure that the facility patients received dialysis treatment in accordnace with their dialysis prescriptions. Failure to ensure that the dialysis prescription was implemented according to the doctor’s orders placed the patients at potential risk of harm, injury, and denied the patients their rights. Patients: #1, 4, and 6. Findings included: The treatment flowsheet is the form used to record the patient’s care during dialysis. Recorded information includes the patient’s blood flow rates (BFR) and the dialysate flow rate (DFR), the patient’s blood pressure, administration of medications, visual observations of the patient and any patient complaints. This information may be hand-written or computer generated. According to the facility’s policy “Patient Assessed and Monitoring,” page 6 revealed, “Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed flow. Check dialysate flow rate setting in correct, and the prescribed flows is being delivered.” A review of six (6) selected patients’ treatment flowsheets on 06/13/2024, revealed that three (3) or 50% of the selected patients did not receive the correct dialysis prescription, as ordered by the Nephrologist. · On treatment date 05/16/2024, Patient #1’s DFR was prescribed for 600 ml/min; however, DFR was set at 500 ml/min from 07:15 a.m. to 11:30 a.m. There was no documentation found explaining why Patient #1’s DFR was not set on the dialysis machine as prescribed. · On treatment date 05/18/2024, Patient #1’s BFR was prescribed for 350 ml/min; however, BFR was set at 300 ml/min from 09:05 a.m. to 11:24 a.m. There was no documentation found explaining why Patient #1’s BFR was not set on the dialysis machine as prescribed. · On treatment date 06/07/2024, Patient #4’s DFR was prescribed for 600 ml/min; however, DFR was set at 700 ml/min from 07:15 a.m. to 11:05 a.m. There was no documentation found explaining why Patient #4’s DFR was not set on the dialysis machine as prescribed. · On treatment date 05/11/2024, Patient #6’s DFR was prescribed for 500 ml/min; however, DFR was set at 400 ml/min from 01:00 p.m. to 03:31 p.m. There was no documentation found explaining why Patient #6’s DFR was not set on the dialysis machine as prescribed. · On treatment date 05/18/2024, Patient #6’s BFR was prescribed for 400 ml/min; however, BFR was set at 300 ml/min from 01:33 p.m. to 02:15 p.m. There was no documentation found explaining why Patient #6’s BFR was not set on the dialysis machine as prescribed. The Clinical Manager was informed of the findings on 06/13/2024.”

“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 patient record review and interviews with the facility’s administration, the governing body and interdisciplinary team (IDT) failed to ensure that an initial comprehensive assessment was conducted on all new patients within the latter of 30 calendar days, or 13 treatments beginning with the first outpatient dialysis session. This failure placed the affected patient at potential risk of harm and denied the patients their rights. Patients: #2, #3, #4, and #6 Findings included: Review on 06/17/2024 of the facility’s policy “Comprehensive Assessment and Plan of Care,” revealed that: “An initial comprehensive assessment (CIA) and plan of care (POC) must be conducted on all patients new to dialysis within the later of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.” On 06/17/2024, review of the six (6) selected patient charts revealed that the initial Comprehensive Assessment for four (4) of the selected patients were not completed. The chart reviews determined the following: · Patient #2 was admitted to the facility in April of 2021; however, there was no initial Comprehensive Assessment found in Patient #2’s paper or electronic chart. · Patient #3 was admitted to the facility in September of 2022; however, there was no initial Comprehensive Assessment found in Patient #3’s paper or electronic chart. · Patient #4 was admitted to the facility in May of 2023; however, there was no initial Comprehensive Assessment found in Patient #4’s paper or electronic chart. · Patient #6 was admitted to the facility in February of 2019; however, there was no initial Comprehensive Assessment found in Patient #6’s paper or electronic chart. The Clinical Manager corroborated that the comprehensive assessments were not completed.”

“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 three (3) month (90-day) comprehensive assessment was completed 3 months after the completion of the initial (30-day) comprehensive assessment. This failure placed the affected patients at potential risk of harm and denied patients their rights to effective care. Patients: #2, #3, #4, and #6 Findings included: On 06/14/2024, the review of the facility’s policy “Comprehensive Interdisciplinary Assessment and Plan of Care,” page 3 revealed that: “A follow-up CIA [Comprehensive Interdisciplinary Assessment] must occur within 90-days. The POC [plan of care] should will be adjusted as appropriate and implemented within 15 days of reassessment.” On 06/17/2024, review of the six (6) selected patient charts revealed that the 90-day comprehensive assessment was not completed. The chart reviews revealed the following: · Patient #2 was admitted to the facility in April 2021; however, there was no 90-day Comprehensive Assessment found in Patient #2’s paper or electronic chart. · Patient #3 was admitted to the facility in September 2022; however, there was no 90-day Comprehensive Assessment found in Patient #3’s paper or electronic chart. · Patient #4 was admitted to the facility in May 2023; however, there was no 90-day Comprehensive Assessment found in Patient #4’s paper or electronic chart. · Patient #6 was admitted to the facility in February 2019; however, there was no 90-day Comprehensive Assessment found in Patient #6’s paper or electronic chart. The Clinical Manager corroborated that the 90-day comprehensive assessments were not completed.”

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- (1) At least annually for stable patients; 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 annual comprehensive assessment was completed 12 months after the completion of the 90-day comprehensive assessment. This failure placed the affected patients at potential risk of harm and denied patients their rights to effective care. Patients: #2, #3, #4, #5, and #6 Findings included: Review on 06/17/2024 of the facility’s policy “Comprehensive Interdisciplinary Assessment and Plan of Care,” page 3 revealed that: “Comprehensive interdisciplinary assessments and modifications to the plan of Care must be conducted 12 months after the completion of the 3 month assessment and then reassessed annually thereafter on stable patients.” On 06/17/2024, review of patient charts Comprehensive Assessments was not completed on five (5) out of the six (6) selected patients. The charts revealed the following: · Patient #2 was admitted to the facility in April 2021; however, there was no annual Comprehensive Assessment found in Patient #2’s paper or electronic chart. · Patient #3 was admitted to the facility on September 2022; However, there was no annual Comprehensive Assessment found in Patient #3’s paper or electronic chart. · Patient #4 was admitted to the facility on May 2023; however, there was no annual Comprehensive Assessment found in Patient #4’s paper or electronic chart. · Patient #5 was admitted to the facility on October 2016; however, there was no annual Comprehensive Assessment found in Patient #5’s paper or electronic chart. · Patient #6 was admitted to the facility on February 2019; however, there was no annual Comprehensive Assessment found in Patient #6’s paper or electronic chart. The Clinical Manager corroborated that the annual comprehensive assessments were not completed for the patients above.”

“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 the facility’s 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: Cross reference to the following tags for policies, which the facility staff failed to follow, and the identified deficient practices: 1. E0028 for the facility ’ s policy “ Emergency Medications, Equipment and Supplies.” 2. V0113 for the facility’s policy “Personal Protective Equipment.” 3. V0122 for the facility’s policy “Prime Bucket Disinfection.” 4. V0147 for the facility’s policy “Changing the Catheter Dressing Procedure.” 5. V0147 for the facility’s policy “Initiation of Treatment Using a Central venous Catheter.” 6. V0228 for the facility’s policy “Concentrate Labeling Requirements.” 7. V0403 for the facility’s policy “Priming an Optiflux Single Use E-Beam Dialyzer.” 8. V0503 for the facility’s policy “Patient Assessed and Monitoring.” 9. V0516 for the facility’s policy “Comprehensive Interdisciplinary Assessment and Plan of Care.” 10. V0517 for facility’s policy “Comprehensive Interdisciplinary Assessment and Plan of Care.” 11. V0519 for the facility’s policy “Comprehensive Interdisciplinary Assessment and Plan of Care.” 12. V0765 for the facility’s policy “Patient Grievance Procedure.””

“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: 44367 Based on review of the patient complaint logs, the facility’s policies and procedures, and interviews with facility staff members and patients, the governing body and the facility’s administration failed to follow the facility’s internal grievance process. This failure denied the patients their rights to advocate for themselves. Patients: #5, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #17, #18, and #20. Findings included: Review on 06/12/2024 of the facility’s policy “Patient Grievance Procedure,” page 2 revealed: “CM [clinical manager] meets with the patient within 5 business days to acknowledge, investigate, and address the grievance...CM reports back to the patient when a resolution is attained or considered attained by the facility.” Review on 06/12/2024 of the facility’s “Patient Grievance Report” revealed that 17 out of 18 grievances received by the facility between 07/19/2023 and 05/24/2024 were not investigated within five (5) days and did not have a resolution. The report revealed the following: · Patient #5 filed a grievance on 12/06/2023. The grievance provided a resolution date for 1/24/2024; however, no resolution was documented. · Patient #11 filed a grievance on 10/27/2023. The grievance provided a resolution date for 1/17/2024; however, no resolution was documented. · Patient #7 filed a grievance on 10/27/2023. The grievance provided a resolution date for 1/24/2024; however, no resolution was documented. · Patient #9 filed a grievance on 10/04/2023. The grievance provided a resolution date for 11/30/2023; however, no resolution was documented. · Patient #10 filed a grievance on 09/25/2023. The grievance provided a resolution date for 1/24/2024; however, no resolution was documented. · Patient #11 filed a grievance on 09/20/2023. The grievance provided a resolution date on 1/17/2024; however, no resolution was documented. · Patient #12 filed a grievance on 07/19/2023. The grievance provided a resolution date on 1/17/2024; however, no resolution was documented. · Patient #9 filed a grievance on 072/19/2023. The grievance provided a resolution date on 11/30/2024; however, no resolution was documented. · Patient #13 filed a grievance on 07/19/2023. The grievance provided a resolution date on 07/24/2023; however, no resolution was documented. · Patient #8 filed a grievance on 07/19/2023. The grievance provided a resolution date on 09/13/2023; however, no resolution was documented. · Patient #14 filed a grievance on 07/19/2023. The grievance provided a resolution date on 09/20/2023; however, no resolution was documented. · Patient #15 filed a grievance on 07/19/2023. The grievance provided a resolution date on 01/12/2024; however, no resolution was documented. · Patient #7 filed a grievance on 07/19/2023. The grievance provided a resolution date on 01/12/2024; however, no resolution was documented. · Patient #16 filed a grievance on 07/19/2023. The grievance provided a resolution date on 01/17/2024; however, no resolution was documented. · Patient #17 filed a grievance on 07/19/2023. The grievance provided a resolution date on 01/12/2024; however, no resolution was documented. · Patient #18 filed a grievance on 12/06/2023. The grievance provided a resolution date on 08/23/2023; however, no resolution was documented. · Patient #20 filed a grievance on 05/14/2024; however, no resolution was documented. On 06/12/2024, the Clinical Manager and the Social Worker were given the opportunity to provide the resolution for each grievance. The Clinical Manager corroborated that the resolutions were not documented.”