Davita Kidney Care of Laurel

“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 file a grievance and advocate for themselves. Patient: #7 Findings included: Review on 04/18/2024 of the facility’s policy #Policy 3-01-06A entitled “Addressing Patient Grievances: DaVita Teammates states: “1. Patient grievances may be verbal or written. They may be submitted directly to a facility teammate or submitted to the DaVita Guest Services department: 2. Complaints/Grievances should be documented on the facility Patient Grievance Log. 3. All details of patient grievances and discussions will be documented. This documentation will be maintained in a separate file and kept in a secure and locked location.” During an interview with Patient #7 on 04/18/2024, the surveyor was informed that he/she filed a complaint with the Facility Administrator in November 2023 regarding lack of assessment from the Charge Nurse. Patient #7 stated that an investigation or resolution was not provided. According to the Facility Administrator, he/she does remember Patient #7 making a complaint; however, the Facility Administrator admitted that the complaint was not documented. On 04/18/2024, the Facility Administrator corroborated that a complaint was not filed on behalf of Patient #7 and a resolution was not provided.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 44367 Based on observations, record reviews, and staff interviews, the facility’s Governing Body, Administration and the Medical Director failed to meet the Condition for Coverage (CfC: 494.60) for Physical Environment, as evidenced by facility’s failure to ensure that patients received their dialysis treatment in a safe environment and on dialysis machines that passed all safety checks prior to use, and were assembled and operated in accordance with manufacturer’s guidelines. This failure placed all patients at increased risk for harm and/or death. The findings include: 1. Cross-reference to tag V0401: Physical Environment - Safe/Functional/Comfortable Environment. 2. 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 was out of compliance with the Condition for Coverage (CfC:494.150) for Responsibilities of The Medical Director, as evidenced by the facility’s Medical Director failure to ensure that the facility’s staff adhered to their own policies and procedures and failure to ensure patient safety and effectiveness before, during and after receiving a dialysis treatment. This failure placed all patients at increased risk for harm and/or death. Findings include: 1) Responsibilities of the Medical Director - Ensure All Adhere to Policy and Procedure (Cross reference to V0710)”

“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 were followed by all staff who come 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: #3 and #8 Findings included: Review on 03/06/2024 of the facility’s policy 1-05-01 entitled, “Infection Control For Dialysis Facilities” states that, “All teammates, Physicians, and Non-Physicians (NPP) will perform hand hygiene: b. prior to gloving and immediately upon removal, c. after contamination with blood or other infectious material, g. before touching clean areas such as supplies, supply cart and chairside.” 1. During observation of the clinical treatment area on 03/06/2024 at 06:44 a.m., the surveyor observed that after treatment initiation of a patient at Station 6 machine #20, Staff #3 removed the soiled gloves and did not complete hand hygiene before using the chairside computer. 2. During observation of the clinical treatment area on 03/08/2024 at 10:42 a.m., the surveyor observed that Staff #8 was assisting the patient at station 12, with an active bleed from the needle site. Staff #8 removed the blood soaked pad and discarded in the biohazard trash can. With the same gloves in place, Staff #8 went to the clean supply counter across from station 9 and opened a new box of 0.9% Normal Saline pre-filled syringes and removed one syringe from the box and then returned to Station 12. The Clinical Specialist was informed of findings on 03/06/2024 and 03/08/2024.”

“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 that patient nutritional supplements/medications were kept in a clean area of the facility separate from the dirty areas. This failure put the patients at risk of contracting infectious diseases due to cross-contamination, which may cause harm. Findings include: Review on 03/12/2024 of the facility’s policy 1-05-01 entitled “Infection Control for Dialysis Facilities” stated that, “Clean areas should be clearly designated for the preparation, handling, and storage of medication and unused supplies and equipment. Clean area should be clearly separated from contaminated areas where used supplies and equipment are handled.” Inspection of the facility’s laboratory area on 03/12/2024 at 11:00 a.m. revealed six (6) bottles of Novasource Renal Complete Nutrition drinks in an unlabeled refrigerator next to the biohazard refrigerator. The laboratory area has a sign that states “dirty.” and should be separate from the facility’s clean areas and supplies. The Clinical Specialist observed and agreed with the findings on 03/12/2024.”

“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 observations of the clinical treatment area, the Facility Administrator 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: #4, #8 and #12 Findings included: The Occupational Health and Safety Administration (OSHA) standard 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. 1. During observations on the clinical treatment area on 03/08/2024 at 10:41 a.m., the surveyor observed that Staff #4 removed the dirty bloodlines and dialyzer (contaminated with blood and normal saline) from station 8 to discard in the biohazardous waste bin in front of occupied station 9. 2. During observations on the clinical treatment area on 03/08/2024 at 10:56 a.m., the surveyor observed that Staff #8 removed the dirty bloodlines and dialyzer (contaminated with blood and normal saline) from station 12 and walked across occupied stations 11 and 10, to discard in the biohazardous waste bin in front of station 9. 3. During observations on the clinical treatment area on 03/08/2024 at 11:09 a.m., the surveyor observed that Staff #12 removed the dirty lines and dialyzer (contaminated with blood and normal saline) from station 13 to discard in the biohazardous waste bin in front of occupied station 14. The Clinical Specialist was informed of the findings on 03/08/2024.”

“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 observations and a review of the facility’s policies and procedures, the governing body failed to ensure that the clinical staff followed the standard regulations in the cleaning and disinfection of contaminated surfaces in the facility. This failure placed the patients at potential risk for exposure to blood-borne pathogens and infectious diseases. Findings included: Review on 03/05/2024 of the facility’s policy 1-05-01 entitled, “Infection Control for Dialysis Facilities” states that, “At the end of each treatment, the dialysis station will be cleaned and disinfected...1. The Wall Box, Drain and Water supply lines are considered part of the dialysis delivery system.” 1. During observation of the clinical treatment area on 03/05/2024 at 05:30 p.m., the surveyor observed white residue on the drain ports and the surface of the wall boxes at the unoccupied stations 3, 7, 8, 9, 12, and 16. 2. During observation of the clinical treatment area on 03/11/2024 at 11:00 a.m., the surveyor observed white residue on the drain ports and the surface of the wall boxes at the unoccupied stations 1, 2, 7, 8, 9, 14, and 15. The Clinical Specialist was informed of the findings on 03/05/2024 and 03/11/2024.”

“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 and expired medications were removed from the available inventory. This failure placed the patients at potential risk of harm and/or infection from cross contamination. Staff: #1 Findings include: Review on 03/05/2024 of the facility’s policy 1-06-01 entitled, “Medication Policy” revealed, “An aseptic environment and aseptic technique is used when preparing medication.” The policy also stated, “Disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment and inventory areas and disposed of per state/local regulations.” Observation of the clinical treatment area on 03/05/2024 at 10:59 a.m. revealed Staff #1 punctured and withdrew medication from an open multi-dose Heparin vial without cleaning the septum. Inspection of the medication area on 03/11/2024 at 10:00 a.m. revealed the following: · Nine (9) vials of Ertapenem 1 gram/vial, lot number 0002E2, expired 12/2023. · Nine (9) vials of Pneumococcal Vaccine, lot number W00100, expired 01/31/2024. · Ten (10) vials of Hepatitis B Vaccine, lot number 9255P, expired 02/15/2024. The Facility Administrator was informed of the findings on 03/05/2024.”

“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: #4, #5, and #9 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 of the facility’s policy 1-04-02B entitled “Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps” states 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 states, “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.” 1. During observation of the clinical treatment area on 03/08/2024 at 07:16 a.m., during initiation of treatment of a CVC patient at station 7 machine #1, Staff #4 scrubbed the venous hub for 2 seconds and scrubbed the arterial hub for 2 seconds after removing the caps and before attaching a clean 10 ml syringe. Staff #4 cleaned the exit site for 24 seconds and only allowed the site to dry for 5 seconds prior to placing a clean dressing. 2. During observation of the clinical treatment area on 03/08/2024 at 11:47 a.m., during initiation of treatment of a CVC patient at station 5 machine #12, Staff #9 did not scrub the venous or arterial hub after removing the caps and before attaching a clean 10 ml syringe. Staff #9 cleaned the exit site for 24 seconds and cleaned from dirty to clean rather than clean to dirty (insertion site to the periphery). 3. During observation of the clinical treatment area on 03/11/2024 at 10:17 a.m., during termination of a CVC patient at station 8 machine #16, Staff #5 scrubbed the venous hub for 4 seconds and scrubbed the arterial hub for 3 seconds after disconnecting the bloodlines from the catheter. Staff #4 cleaned the exit site for 24 seconds and only allowed the site to dry for 5 seconds prior to placing a clean dressing. The Facility Administrator was informed of the findings on 03/08/2024 and 3/11/2024.”

“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 interviews with the clinical staff, observations of the clinical treatment area and a review of the facility’s policies and procedure, the facility’s administration and the medical director failed to ensure that all containers and their content were labeled correctly. This failure placed the patients at potential risk for harm. Findings include: Review on 03/05/2024 of the facility’s policy 1-05-08A entitled “Preparation of One to One to Ten (1:10) Bleach Solution” states, “With a indelible marking pen and label, label container with expiration date, time, and initials. The solution is good for 24 hours only.” Review on 03/05/2024 of the facility’s policy 1-05-08B entitled “Preparation of One to One Hundred (1:100) Bleach Solution” states, “With a indelible marking pen and label, label container with expiration date, time, and initials. The solution is good for 24 hours only.” During observation of the clinical treatment area on 03/06/2024 at 6:00 a.m., the surveyor observed two containers half full with clear yellow liquid on the sink labeled “dirty” across from station 12. One container was labeled “1:10 Bleach Solution” and the other container was labeled “1:100 Bleach Solution.” Neither container was labeled with the date, time and initials per policy. The Clinical Specialist observed and agreed with the findings on 03/06/2024.”

“BICARB MIX SYS-STOR/USE TIME/MIN COMBINE CFR(s): 494.40(a) 5.4.4.3 Bicarbonate concentrate mixing systems: storage/use time limits/min combine Once mixed, bicarbonate concentrate should be used within the time specified by the manufacturer of the concentrate. 7 Strategies for bacterial control 7.1 General Storage times for bicarbonate concentrate should be minimized, as well as the mixing of fresh bicarbonate concentrate with unused portions of concentrate from a previous batch. The manufacturer’s instructions should be followed if they are available. This Standard is not met as evidenced by: 44367 Based on observations, the Facility’s Administration and the Medical Director failed to ensure that the bicarbonate mixture was discarded at the end of the day. This failure placed the patient affected at potential risk of harm and or death. Findings include: Review on 03/05/2024 of the facility’s policy 2-07-01 entitled, “Bicarbonate Concentrate System Mixing” states, “Bicarbonate concentrate is to be used the same day that it is mixed... Any bicarbonate concentrate left over at the end of the treatment day is to be discarded.” During the observational flash tour on 03/05/2024 at 10:30 a.m., the half full tank labeled Bicarbonate, was labeled “3/2/2024 5:40 a.m. KK.” According to the label the mixture was mixed three days prior to the observation. The Facility Administrator observed the findings with the surveyor on 03/05/2024.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 44367 Based on observations, the Facility’s Administration and the Medical Director failed to ensure that the pH is tested before starting the treatment of each patient. This failure placed the patient affected at potential risk of harm. Staff #6 Findings Included: According to the facility’s policy 2-08-01B “Operation of Portable Myron L Conductivity Meter”, “Manual pH testing must be performed prior to each patient treatment.” 1. On 03/06/2024 at 06:19 a.m., Staff #6 did not test the pH of machine #9 at station 9, prior to initiating the patient’s treatment. 2. On 03/06/2024 at 07:08 a.m., Staff #6 did not test the pH of machine #7 at station 7, prior to initiating the patient’s treatment. The Clinical Specialist was informed of the findings on 03/06/2024.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 44367 Based on observations, record reviews, and staff interviews, it was determined that the facility’s governing body failed to ensure that 1) the facility staff assembled and operated dialysis machines in accordance with the manufacturer’s recommendations and that the dialysis machines passed safety testing prior to initiating patient treatment; and 2) the facility staff conducted fire drills. This failure placed facility patients at risk for harm and/or death. Findings: Staff: #1, #5, #6, #11 and #13 1) On 03/05/2024 at 10:59 a.m. at station 16, the surveyor observed the machine fail the alarm test three consecutive times. At 11:07 a.m., the Patient Care Technician or PCT (Staff #1) initiated Patient #6’s treatment. At 11:09 a.m., the surveyor asked the Staff #1 to show the tests that were completed on the machine. The surveyor noted that the machine display showed that the machine failed the “venous” testing portion. The surveyor asked the Staff #1 to explain why the machine failed. Staff #1 placed his/her finger on top of the air detector (chamber that detects air and automatically stops the treatment if detected), pressing on the silver clamp and informed the surveyor that “this is the reason the machine failed.” On 03/05/2024 at 12:45 p.m., during interviews with Charge Nurse (Staff#11), the surveyor discovered that Staff #11 was not informed of the machine failure. Staff #11 corroborated that, based on the facility’s policies and procedure, Staff #1 should have pulled the machine from any use after it failed testing. Review on 03/05/2024, of the policy 02-01-04 titled “Dialysis Delivery System Failures Occurring During Treatment” page 3 states, “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.” On 03/03/2024 Review of medical record documentation revealed that Staff #1 documented into the record that the machine passed the safety testing when it did not. On 03/05/2024 at 12:50 p.m., Staff #13, who requested anonymity, told the surveyor during an interview that “machines fail here all the time because they are old,” and that this was an ongoing issue. Staff #13 also informed the surveyor that he/she had seen other staff members also use machines after failed testing due to conductivity. On 03/05/2024 at 01:15 p.m. during an interview with Staff #1, the staff informed the surveyor that he/she was unaware of a policy regarding machine testing and has “never seen a policy.” Staff #1 stated that his/her colleagues would use a machine if it failed conductivity, so he/she thought it was “ok to do.” Review on 03/05/2024 of the facility’s policy entitled 1-03-06W “Priming a Single Use Dialyzer Utilizing Fresenius 2008 series Dialysis Delivery Systems and Nipro Or Combiset BloodLines for Subsequent Treatment Shifts” page 28 states “Acceptable range for machine displayed and theoretical conductivity (TCD) is 13-15.5 mS. If the physician orders dialysate sodium of 136 or less in specific circumstances, then the acceptable range is 12.8-15.5 mS. If the machine display or TCD is not within this range on the dialysate screen, do not initiate treatment and investigate the reason the values are outside the acceptable range.” On 03/05/2024 at 06:00 p.m., during observations of the machine testing on the treatment floor, the surveyors observed 3 out of the 7 (43%) selected machines failed the initial testing. 2 out of the 7 (29%) failed the secondary testing. Interviews with the clinical specialist and a patient care technician on 03/05/2024 at approximately 06:30 p.m. confirmed that staff could bypass the failed safety testing by pressing the reset button. Both staff demonstrated to the surveyors the use of the reset button overriding the safety alarm feature; which allowed the machine to enter the mode to start treatment. Further observation of the facility’s machines prior to patient treatment initiation were documented as follows: On 03/06/2024 from 05:30 a.m. through 08:30 p.m., there were 13 out of 18 machines that failed the initial test and 2 out of the 13 failed machines, were removed from service due to failing the second test. On 03/07/2024 from 05:30 a.m. through 05:30 p.m., there were 13 out of 18 machines that failed the initial test and 5 out of the 13 failed machines, were removed from service due to failing the second test. On 03/08/2024 from 05:30 a.m. through 11:30 p.m., there were 3 out of 18 machines that failed the first test and 1 out of the 3 failed machines, were removed from service due to failing the second test. On 03/06/2024 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 03/06/2024 at 02:43 p.m., during observations of the treatment floor, the surveyors observed the following: At 02:43 p.m., Staff #5 tested dialysis machine #17 located in Station #4 without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector). At 11:44 a.m., Staff #5 tested dialysis machine #17 located in Station #4 without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector). At 03:21 p.m., Staff #6 tested dialysis machine #12 located in Station #6 without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector). At 03:22 p.m., the Clinical Specialist corroborated that machine #12 located in Station #6 did not have the tubing beneath the venous drip chamber properly inserted into the venous line clamp and the optical detector (air detector). Cross referenced with V0403. 2) Review on 03/12/2024 of the facility’s policy 4-07-01 entitled “Facility Emergency Management Plan” revealed, “Fire safety drills: Required on a Quarterly basis.” During review of the emergency preparedness binder on 03/12/2024, the surveyor noted that the facility did not conduct the required fire drills. The Facility Administrator was given the opportunity to provide documentation that fire drills were conducted; however, no additional documentation was provided. The Facility Administrator corroborated that the facility has not conducted fire drills. The Facility Administrator was informed of the findings on 03/05/202 and 03/12/2024.”

“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 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 was evident when 1) the facility staff bypassed alarms and utilized equipment after failed safety checks on Patient #6; and 2) the facility staff initiated the required safety testing while elements of the machine were not assembled according to manufacturer instructions. These failures rendered the safety test results invalid and placed the affected patients at potential risk of serious injury, serious harm, and possible death. Findings include: 1) On 3/05/2024 at 10:59 a.m. at station 16, the surveyor observed the machine fail the alarm test three consecutive times. a. At 11:07 a.m., the PCT initiated the treatment for Patient #6. At 11:09 a.m., the surveyor asked the PCT to show the tests that were completed on the machine. The surveyor noted that the machine display showed that the machine failed the “venous” testing portion. The surveyor asked the PCT to explain why the machine failed. The PCT placed his/her finger on top of the air detector (chamber that detects air and automatically stops the treatment if detected), pressing on the silver clamp and informed the surveyor that “this is the reason the machine failed.” b. On 03/05/2024 at 12:45 p.m., during interviews with Registered Nurse (RN)#1, the surveyor discovered that RN #1 was not informed of the machine failure. The RN corroborated that, based on the facility’s policies and procedure, PCT #1 should have pulled the machine from any use after it failed testing. c. Review of medical record documentation revealed that staff documented into the record that the machine passed the safety testing when it had not. d. On 3/5/2024 at 12:50 p.m., Staff #2 told the surveyor during an interview that “machines fail here all the time because they are old,” and that this was an ongoing issue. The staff also informed the surveyor that he/she had seen other staff members also use machines after failed testing due to conductivity. e. On 3/5/2024 at 1:15 p.m. during an interview with PCT #1, the staff informed the surveyor that he/she was unaware of a policy regarding machine testing and has “never seen a policy”. The PCT stated that his/her colleagues would use a machine if it failed conductivity, so he/she thought it was “ok to do.” f. On 03/05/2024 at 02:45 p.m., review of the facility’s policies and procedures revealed the following: i. Policy titled “Dialysis Delivery System Failures Occurring During Treatment” (02-01-04) page 3 states, “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” ii. Policy titled “Priming a Single Use Dialyzer Utilizing Fresenius 2008 series Dialysis Delivery Systems and Nipro Or Combiset BloodLines for Subsequent Treatment Shifts.” (Procedure 1-03-06W) Page 28 states “Acceptable range for machine displayed and theoretical conductivity (TCD) is 13-15.5 mS. If the physician orders dialysate sodium of 136 or less in specific circumstances, then the acceptable range is 12.8-15.5 mS. If the machine display or TCD is not within this range on the dialysate screen, do not initiate treatment and investigate the reason the values are outside the acceptable range.” g. On 03/05/2024 at 06:00 p.m., during observations of the machine testing on the treatment floor, the surveyors observed 3 out of the 7 (43%) selected machines failed the initial testing. 2 out of the 7 (29%) failed the secondary testing. Interviews with the clinical specialist and a patient care technician on 03/05/2024 at approximately 06:30 p.m. confirmed that staff could bypass the failed safety testing by pressing the reset button. Both staff demonstrated to the surveyors the use of the reset button overriding the safety alarm feature; which allowed the machine to enter the mode to start treatment. The facility’s practice of initiating dialysis treatment on the dialysis equipment that failed safety checks 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, by passing alarms and using equipment after failed safety checks, an immediate jeopardy (IJ) statement #1 was issued at 7:30 p.m. on 3/5/2024 by the Office of Health Care Quality (OHCQ). 2) On 03/06/2024 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.” a. On 03/06/2024, during observations of the treatment floor, the surveyors observed the following: b. At 02:43 p.m., Staff #5 tested dialysis machine #17 located in Station #4 without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector). c. At 11:44 a.m., Staff #5 tested dialysis machine #17 located in Station #4 without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector). d. At 03:21 p.m., Staff #6 tested dialysis machine #12 located in Station #6 without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector). e. At 03:22 p.m., the Clinical Specialist corroborated that machine #12 located in Station #6 did not have the tubing beneath the venous drip chamber properly inserted into the venous line clamp and the optical detector (air detector). Failing to follow manufacturer’s instructions for the machine set up prior to initiating the initial safety test of the machine rendered the initial passing safety test results invalid. This practice was observed amongst two staff during the initiation of the dialysis for three patients. Staff did not reset and retest for these patients until after surveyor intervention. The safety testing is critical but was of particular import in this facility, as 11 of 18 machines in the facility have failed the safety test(s) during the survey dates of 3/5/24 and 3/6/24. 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 #2 was issued at 5:30 p.m. on 3/6/2024 by the Office of Health Care Quality (OHCQ). On 3/8/2024 at 2:48 p.m., the survey team verified that the facility implemented an acceptable abatement plan and both IJs were determined to be abated. The Plan of immediacy was written by the facility as follows: On March 5, 2024, in response to the Immediate Jeopardy citation, the Facility Administrator immediately initiated actions to address the findings. Actions 1. The Manager of Clinical Services and Facility Administrator held an immediate in-service on 3/05/24 to re-educate clinical teammates (Registered Nurse or Patient Care Technician) who were currently working and responsible for patient monitoring. Re-education of all remaining clinical teammates (Registered Nurse or Patient Care Technician) will be completed upon their return to work and prior to performing machine set up and/or treatment monitoring tasks. Education will include but not be limited to: a. A review of Policy 2-01-04 Dialysis Delivery System Failures Occurring during Treatment emphasizing i. If the dialysis delivery system fails any of the tests (alarm and pressure holding) and the cause cannot be corrected, or if it fails subsequent tests (alarm and pressure holding), it will not be used for treatment. ii. Remove the dialysis delivery system from service and have it inspected by a qualified Biomed teammate to correct the problem. iii. If a dialysis delivery system has an alarm condition during treatment, the clinical teammate (Registered Nurse or Patient Care Technician) is to follow the recommended Operator Troubleshooting Guidelines found in the Operator’s Manual for that particular dialysis delivery system. If the alarm cannot be attributed to an external condition, the treatment will be stopped, the dialysis delivery system replaced, and the dialysis delivery system labeled with a description of the problem and identity of the clinical teammate (Registered Nurse or Patient Care Technician) describing the problem. The labeled dialysis delivery system will be removed from the treatment area for repairs. iv. If a dialysis delivery system has an intermittent problem, the charge nurse will make a determination whether the treatment should continue with that particular dialysis delivery system or not. In either case, the dialysis delivery system will be labeled post treatment with a description of the problem and the identity of the clinical teammate (Registered Nurse or Patient Care Technician) describing the problem. The labeled dialysis delivery system will be removed from the treatment area for repairs. b. A review of Policy 1-03-06V Machine Start Up and Priming a Single Dialyzer Utilizing Fresenius 2008 Series and NIPRO or Combiset Blood Lines for First Shift of Day emphasizing if the dialysis delivery system fails any of the tests (alarm and pressure holding) and the cause cannot be corrected or if it fails subsequent tests (alarm and pressure holding) the dialysis delivery system should not be used for treatment. c. A review of Policy 1-03-06W Priming a Single Dialyzer Utilizing Fresenius 2008 Series and NIPRO or Combiset Blood Lines for Subsequent Treatment Shifts emphasizing: i. if the dialysis delivery system fails any of the tests (alarm and pressure holding) and the cause cannot be corrected or if it fails subsequent tests (alarm and pressure holding) the dialysis delivery system should not be used for treatment. ii. Acceptable range for machine displayed and theoretical conductivity (TCD) is 13-15.5 mS. If the physician orders dialysate sodium of 136 or less in specific circumstances, then the acceptable range is 12.8-15.5 mS. If the machine display or TCD is not within this range on the dialysate screen, do not initiate treatment and investigate the reason the values are outside the acceptable range. d. The clinical teammates (Registered Nurse or Patient Care Technician) were instructed to never bypass the failed safety testing and never to enter documentation of passed safety testing if it is not true. If found to have done so, they will receive disciplinary actions up to and including termination. e. Verification of re-education will be evidenced by the clinical teammates (Registered Nurse or Patient Care Technician) signature on in-service sheet. 2. The Manager of Clinical Services held additional in-services on 3/06/24 for the clinical teammates (Registered Nurse or Patient Care Technician) who were currently working and responsible for machine and patient monitoring. Re-education of all remaining teammates (Registered Nurse or Patient Care Technician) will be completed upon them return to work and prior to performing machine set up and/or treatment monitoring tasks. Education will include but not be limited to: a. Policy 2-01-04 Dialysis Delivery System Failures Occurring during Treatment emphasizing: i. If the dialysis delivery system fails any of the tests (alarm and pressure holding) and the cause cannot be corrected, or if it fails subsequent tests (alarm and pressure holding), it will not be used for treatment. ii. Remove the dialysis delivery system from service and have it inspected by a qualified Biomed teammate to correct the problem. iii. If a dialysis delivery system has an alarm condition during treatment, the clinical teammate (Registered Nurse or Patient Care Technician) is to follow the recommended Operator Troubleshooting Guidelines found in the Operator’s Manual for that particular dialysis delivery system. If the alarm cannot be attributed to an external condition, the treatment will be stopped, the dialysis delivery system replaced, and the dialysis delivery system labeled with a description of the problem and identity of the clinical teammate (Registered Nurse or Patient Care Technician) describing the problem. The labeled dialysis delivery system will be removed from the treatment area for repairs. iv. If a dialysis delivery system has an intermittent problem, the charge nurse will make a determination whether the treatment should continue with that particular dialysis delivery system or not. In either case, the dialysis delivery system will be labeled post treatment with a description of the problem and the identity of the clinical teammate (Registered Nurse or Patient Care Technician) describing the problem. The labeled dialysis delivery system will be removed from the treatment area for repairs. b. 1-03-06V Machine Start Up and Priming a Single Dialyzer Utilizing Fresenius 2008 Series and NIPRO or Combiset Blood Lines for First Shift of Day emphasizing if the dialysis delivery system fails any of the tests (alarm and pressure holding) and the cause cannot be corrected or if it fails subsequent tests (alarm and pressure holding) the dialysis delivery system should not be used for treatment. c. Policy 1-03-06W Priming a Single Dialyzer Utilizing Fresenius 2008 Series and NIPRO or Combiset Blood Lines for Subsequent Treatment Shifts emphasizing: i. if the dialysis delivery system fails any of the tests (alarm and pressure holding) and the cause cannot be corrected or if it fails subsequent tests (alarm and pressure holding) the dialysis delivery system should not be used for treatment. ii. Acceptable range for machine displayed and theoretical conductivity (TCD) is 13-15.5 mS. If the physician orders dialysate sodium of 136 or less in specific circumstances, then the acceptable range is 12.8-15.5 mS. If the machine display or TCD is not within this range on the dialysate screen, do not initiate treatment and investigate the reason the values are outside the acceptable range. d. Policy 2-02-01M Fresenius 2008 K, K2, T Pressure Holding/ Alarm Test emphasizing 1) this test must be performed prior to each treatment. 2) The dialysis delivery system must be in dialysis mode and free from alarm conditions. 3) An audible alarm sounds after all tests (alarm and pressure holding) have been completed. If all tests (alarm and pressure holding) are completed successfully, a message Test Passed appears in the Status box. e. Policy 1-03-02 Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate emphasizing 1) independent pH testing is required to be performed prior to each treatment. 2) The acceptable range for final dialysate pH is 6.9-7.6. 3) If independent results are not within acceptable range, recalibrate meter and retest. If results are still outside acceptable range, do not use the delivery system for patient treatment. Label the delivery system and notify the charge nurse and biomed. f. Starting 3/06/24, a two-step verification process was implemented for safety testing and documentation. i. The clinical teammate #1 (Registered Nurse or Patient Care Technician) will conduct the safety test and document in CWOW (electronic medical record). ii. The clinical teammate #2 (Registered Nurse or Patient Care Technician) will verify the results of the machine safety test (pass or fail) prior to treatment initiation and document in CWOW (electronic medical record). 3. Nine (9) of the twelve (12) full-time clinical teammates (Registered Nurse or Patient Care Technician) will have competency skills verification completed 03/06/24. Three (3) of the full-time clinical teammates (Registered Nurse or Patient Care Technician) will have competency skills verified 03/07/24. Any clinical teammate (Registered Nurse or Patient Care Technician) unable to report for training will have competency skills verified upon reporting for work prior to performing any tasks including machine set-up and patient and machine monitoring. 4. Clinical Teammate # 2 who was identified on 3/05/24 during this survey received disciplinary action for falsified documentation on 3/05/24. 5. The Biomedical Operations Manager along with other biomedical technicians were immediately contacted to evaluate the status of all dialysis machines. a. On 3/05/24, once all patient treatments were completed for the day, seven (7) of the twenty-one (21) Fresenius 2008 Series dialysis machines were turned on (per surveyor request), for evaluation. i. Three (3) failed alarm testing. One (1) due to a heater switch that was resolved immediately and two (2) failed due to the 9V battery needing to be replaced. ii. All identified issues were resolved, and the dialysis machines are all functioning now. b. Each of the twenty-one (21) Fresenius 2008 Series dialysis machines were then tested on 3/05/24 to verify functionality of each machine. c. Of the twenty-one (21) Fresenius 2008 Series dialysis machines, one (1) alarmed “positive stabilized” indicating an issue with positive pressure. The issue was addressed immediately, and the dialysis machine is now functioning. d. On 3/06/24, during machine set-up, two (2) machines were noted to have issues and were pulled for evaluation. One (1) dialysis machine had a missing line clamp. The part was requested on 3/06/24, machine repaired and in now functional. One (1) dialysis machine was noted to have a high pH testing, the machine was pulled for evaluation and found that the bicarbonate setting needed to be adjust. The dialysis machine is now functional. e. The facility has three (3) machines fully functional dialysis machines available as back-up in the event of future dialysis machine issues. f. All repairs are entered into the Biomedical Reporting System known as BART and available for review as needed. g. All clinical teammates (Registered Nurse or Patient Care Technician) were instructed to notify the charge nurse and the biomedical service specialist immediately when a dialysis machine is pulled for repair. The dialysis machine will be labeled with a description of the problem and the identity of the clinical teammate (Registered Nurse or Patient Care Technician) describing the problem. h. Effective January of 2024, the facility has a full time qualified Biomed Service Specialist assigned and available when needed. i. In the event there are not enough machines available to deliver dialysis to the scheduled patients, the facility will follow this process: i. The charge nurse will triage the patients to identify the need for immediate dialysis and contact their attending physician. ii. The facility will utilize the existing back-up agreements with the surrounding facilities to secure a treatment time for the patients needing immediate dialysis. iii. If the warranted, the facility will re-schedule the patient’s treatment for the next day. 6. A binder has been created to track all machine issues. a. The repair request forms will be tracked, trended, and maintained within the binder and reviewed with the Facility Administrator weekly. b. The Biomed Service Specialist will review the finding on a weekly basis and provide a monthly summary with the Medical Director during the monthly Facility Health Meeting. An improvement plan will be developed, if necessary, which will be followed monthly during the meeting. 7. Starting 3/06/24, the Manager of Clinical Services, Clinical Coordinator and/or Qualified Clinical Leader will provide coaching and clinical oversight daily while observing the machine set-up for one hundred percent (100%) of the dialysis machines in use to verify: a. all dialysis machine alarm issues are addressed immediately and per policy and procedure. b. machines are labeled and removed from the treatment area when indicated and c. all patients are receiving dialysis treatments using a fully functional and safe dialysis machine. d. two (2) clinical teammates (Registered Nurse or Patient Care Technician) verified the dialysis machine passed all safety testing (machine auto alarm testing, pressure holding testing, and venous line is positioned with-in the air detector) prior to initiation of treatment. e. The qualified clinical leader will provide immediate coaching to the clinical teammates (Registered Nurse or Patient Care Technician) to ensure all policy and procedures are adhered to. The clinical leader will then debrief the Facility Administrator to document coaching conversation in the clinical teammate file (Registered Nurse or Patient Care Technician) to track clinical performance. 8. Additionally, the Facility Administrator or Clinical Coordinator will meet with the Biomedical Operations Manager daily to review the status of all dialysis machines. 9. Lasty, in addition to the clinical oversight, the Facility Administrator or designee will perform and document observational audits every shift to verify: a. All dialysis machines pass the alarm testing including alarm and pressure holding test prior to initiation of treatment. b. There is documentation in the electronic medical record of a second clinical teammate (Registered Nurse or Patient Care Technician) verifying the dialysis machine passing the safety checks. c. All dialysis machine not passing the alarm testing including alarm and pressure holding test are removed from the treatment area. prior to initiation of treatment. Instances of non-compliance will be addressed immediately. 10. In response to the surveyor’s observations while on the treatment floor on 3/06/24 when clinical teammates #5 and #6 were observed performing dialysis machine testing without inserting the tubing beneath the venous drip chamber into the venous line clamp and the optical detector (air detector), these immediate actions were implemented. a. The Manager of Clinical Services held an immediate homeroom meeting for all the clinical teammates(Registered Nurse or Patient Care Technician) including (clinical teammate # 5 and # 6) who were currently working and responsible for machine monitoring to review Policy 1-03-06V Machine Start Up and Priming a Single Dialyzer Utilizing Fresenius 2008 Series and NIPRO or Combiset Blood Lines for First Shift of Day and Policy 1-03-06W Priming a Single Dialyzer Utilizing Fresenius 2008 Series and NIPRO or Combiset Blood Lines for Subsequent Treatment Shifts emphasizing that the clinical teammates (Registered Nurse or Patient Care Technician) must thread venous blood line through line clamp of air detector. Press “Reset” to clear the air detector alarm. NOTE: This step must be completed to verify that line clamp is operational during treatment and in an alarm condition. The Fresenius 2008T Machine Operator’s Manual, states the tubing beneath the venous drip chamber must be inserted into the venous line clamp and the optical detector. b. Re-education will be provided to clinical teammates (Registered Nurse or Patient Care Technician) who were not scheduled to work on 3/06/24 upon their return to work and prior to performing machine set up and/or treatment monitoring tasks. c. The Facility Administrator and Manager of Clinical Services began the corrective action process for clinical teammate # 5 and # 6 by contacting Teammate Relations for guidance on clinical teammate disciplinary action. Per their recommendation, the teammate # 5 was pulled from the floor immediately and a coaching conversation was completed and documented with teammate relations. Clinical teammate #6 was immediately in-serviced while on the floor by the Manager of Clinical Services and the Facility Administrator completed a corrective action for the violation. d. Starting 3/07/24, as part of the auditing process, the Manager of Clinical Services, Clinical Coordinator and/or Qualified Clinical Leader will verify that the tubing is inserted into the venous line clamp and the optical detector (air detector) prior to initiating the alarm testing. 11. A Governing Body Meeting was held on 3/05/24, 3/06/24 and 3/07/24 to review the citation received during the survey taking place on 3/05/24. Members of Governing Body including the Medical Director, Facility Administrator, Regional Operations Director, and Nurse Manager have agreed to meet daily to monitor facilities’ ongoing progress toward compliance with this plan. Those clinical teammates (Registered Nurse or Patient Care Technician) not scheduled or on vacation will be educated upon return and prior to performing patient monitoring. The Facility Administrator will review results of all plans of correction audits with clinical teammates (Registered Nurse or Patient Care Technician) during clinical teammate homeroom meetings and Medical Director during monthly Quality Assurance and Performance Improvement Meetings known as Facility Health Meetings. 12. On 3/07/24, the Governing Body made the decision to replace the twenty-one (21) Fresenius 2008 Series dialysis machines currently in service. a. Twenty-one (21) Blue Star Premium Dialysis machines were ordered on 3/7/24. 13. The plan of correction will be monitored during Governing Body meetings until sustained compliance is achieved. This plan of correction will also be reviewed during the next Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance, with supporting documentation included in meeting minutes. The Facility Administrator on behalf of the Governing Body is responsible for compliance with this plan of correction. 14. Compliance date 03/07/2024”

“PR-CAN HAVE ADVANCE DIR,TOLD FAC AD P&P CFR(s): 494.70(a)(6) The patient has the right to- (6) Be informed about his or her right to execute advance directives, and the facility ’ s policy regarding advance directives; 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 patients had a completed Medical Orders for Life-Sustaining Treatment Form (MOLST) on their patient records and were given information about creating an advance directive in a prompt manner. This failure denied the patients their rights to formulate treatment decisions that served their end of life needs. Patients: #5 and #7 Findings included: Section 10.01.21.04B - Use of the MOLST Form of the Code of Maryland Regulations (COMAR) requires: Beginning July 1, 2013, the following health care facilities are required to accept, update if appropriate, and complete the MOLST form for each patient during the admission process in accordance with the form’s instructions: (1) An assisted living program; (2) A home health agency; (3) A hospice; (4) A kidney dialysis center; and (5) A nursing home. Review on 03/12/2024 of the facility’s policy 3-02-19 entitled “MOLST Form” revealed, “This is a document that must be prepared for each patient.” A review of the medical records on 03/12/2024 revealed that two (2) out of eight (8) or 25% of the selected patients selected did not have a MOLST form in their chart. · Patient #5 was admitted on 10/09/2023. No MOLST form was found in Patient #5’s chart. · Patient #7 was admitted on 12/11/2023. No MOLST form was found in Patient #7’s chart. The Facility Administrator was informed of the findings and given the opportunity to provide the completed MOLST forms on 03/12/2024; however, no documentation was provided.”

“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 record 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 the patients’ 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, #4, #5, #6 and #8 Findings included: The facility’s policy 1-03-07 “New Patient Pre-Treatment Evaluation” page 1 states, “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.” During inspection of the patients’ charts on 03/12/2024, the surveyor noted that 6 out of the 8 (75%) selected patients did not have an initial nursing assessment or the assessment was completed after the first treatment. · Patient #1 was admitted on 02/05/2024. No initial nursing assessment was found in the patient’s chart. · Patient #2 was admitted on 05/03/2023. No initial nursing assessment was found in the patient’s chart. · Patient #4 was admitted on 12/12/2022; however, the initial nursing assessment was completed on 12/17/2022. The assessment was completed 5 days after the first treatment. · Patient #5 was admitted on 10/09/2023. No initial nursing assessment was found in the patient’s chart. · Patient #6 was admitted on 10/28/2021. No initial nursing assessment was found in the patient’s chart. · Patient #8 was admitted on 01/12/2024. No initial nursing assessment was found in the patient’s chart. The Facility Administrator was informed of the findings and given the opportunity to provide the initial nursing assessments on 03/12/2024; however, no documentation was provided.”

“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: #1 and #8 Findings included: Review on 03/12/2024 of the facility’s policy 1-14-01 entitled “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 03/12/2024 of the facility’s medical records revealed that 2 out of the 8 (25%) of the selected patients did not have a 30-day assessment completed. · Patient #1 was admitted on 02/05/2024. No 30-day assessment was found in Patient #1’s chart. · Patient #8 was admitted on 01/12/2024. No 30-day assessment was found in Patient #8’s chart. The Facility Administrator was informed of the findings and given the opportunity to provide the 30-day assessments on 03/12/2024; however, no documentation was provided.”

“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: #5 and #7 Findings included: Review on 03/12/2024 of the facility’s policy 1-14-01 entitled “Patient Assessment and Plan of Care” states, “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 03/12/2024 of the facility’s medical records revealed that 2 out of the 8 (25%) of the selected patients did not have a 90-day assessment completed. Patient #5 was admitted on 10/09/2023. No 90-day assessment was found in Patient #5’s chart. Patient #7 was admitted on 12/11/2023. No 90-day assessment was found in Patient #7’s chart. The Facility Administrator was informed of the findings and given the opportunity to provide the 90-day assessments on 03/12/2024; however, no documentation was provided.”

“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 complied with the appropriate procedures when assessing the patients’ vascular access prior to cannulation and practiced the correct infection control protocol. This failure placed the safety and well-being of the patients at potential risk of harm in maintaining their vascular access. Staff: #3 and #10 Findings included: Review on 03/06/2024 of the facility’s policy entitled “Cannulation of Fistula or Graft”, Procedure 01-04-01E states: “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.” 1. During observation of the clinical treatment area on 03/06/2024 at 06:48 a.m., the surveyor noted that at station 6 machine 14, Staff #3 palpated patient’s access after disinfecting it, prior to cannulation. 2. During observation of the clinical treatment area on 03/06/2024 at 06:56 a.m., the surveyor noted that at station 12 machine 10, Staff #10 palpated patient’s access after disinfecting it, prior to cannulation. The Clinical Specialist was informed of the findings on 03/06/2024.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 44367 Based on interviews, review of the Quality Assessment and Performance Improvement (QAPI) meeting minutes and review of the facility’s policies and procedures, the governing body and the Medical Director failed to ensure the facility’s interdisciplinary team (IDT) analyzed, tracked and created action plans related to Mortality Review, despite multiple cardiac related deaths occurred at the facility. This failure denied patient effective and safe dialysis which placed the patients at risk for harm and/or death. Patients: #9, #10, #11, #12, #13, #14, #15, #16, #17, #18, #19 and #20 Findings include: Review on 03/12/2024 of the facility’s policy 1-14-06 entitled “Continuous Quality Improvement Program” revealed that “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; 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.” During review on 03/12/2024 of the the facility’s Quality Assessment and Performance Improvement (QAPI) meeting minutes from January 2023 through February 2024, the surveyor noted that the facility did not evaluate and trend patient deaths, and no efforts were implemented to address adverse trends potentially related to care received at the facility. Despite eight (8) cardiac related deaths (Patients #9, 10, 11, 12, 13, 14, 15, and 16), including two (2) deaths (Patients #12 and 16) that occurred while on the dialysis machine receiving treatment. The facility also had three patients (Patients #18, 19, and 20) that died between January 2023 and February 2024, but no cause of death was documented in QAPI or provided to the surveyor.. On 03/12/2024, the Facility Administrator corroborated that the facility did not investigate the root cause and create goals and plans for the facility’s deaths that occurred between January 2023 through February 2024.”

“PQ-PCT-STATE REQUIREMENTS & HS DIPLOMA CFR(s): 494.140(e)(1),(2) Patient care dialysis technicians must- (1) Meet all applicable State requirements for education, training, credentialing, competency, standards of practice, certification, and licensure in the State in which he or she is employed as a dialysis technician; and (2) Have a high school diploma or equivalency; This Standard is not met as evidenced by: 44367 Based on the review of credentialing records, quality assurance meeting minutes and patient medical records, the governing body failed to ensure that all dialysis technicians met all applicable state requirements for credentialing, standards of practice, certification and licensure in the state in which he or she is employed as a dialysis technician. Staff: #4 Findings included: According to the Maryland Board of Nursing, “All out-of-state applicants must complete the Board’s certification process prior to practicing as a CNA-DT.” (Retrieved on 03/12/2024 from https://mbon.maryland.gov/Pages/cna-cna-dt.aspx) During an interview with the Facility Administrator and review of employee personal files on 03/12/2024, the surveyor determined that Staff #4 came from another state and worked as Patient Care Technician (PCT) without the required current state certification. The surveyor noted that Staff #4 worked independently on 03/08/2024, 03/09/2021, and 03/11/2024. The Facility Administrator corroborated that Staff #4 did not have the required state certification and that he/she was unaware that Staff #4 did not have the proper certification for the state of Maryland.”

“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: The Medical Director acts as the senior clinical leader in a dialysis facility and is responsible for both communicating and listening to the medical staff in determination of those clinical policies to which the entire staff in the facility will adhere. Cross reference tags: V0113 for facility’s policy 1-05-01, “Infection Control for Dialysis Facilities” V0117 and for the facility’s policy 1-05-01, “Infection Control for Dialysis Facilities” V0122 and for the facility’s policy 1-05-01, “Infection Control for Dialysis Facilities” V0143 for the facility’s policy 1-06-01, “Medication Policy” V0147 for the facility’s policy 1-04-02B, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps” V0250 for the facility’s policy 2-08-01B, “Operation of Portable Myron L Conductivity Meter” V0401 for the facility’s policy, 2-01-04 “Dialysis Delivery System Failures Occurring During Treatment” V0401 for the facility’s policy 4-07-01, “Facility Emergency Management Plan V0403 for facility’s policy, 1-03-06W “Priming a Single Use Dialyzer Utilizing Fresenius 2008 series Dialysis Delivery Systems and Nipro Or Combiset BloodLines for Subsequent Treatment Shifts” V0403 for the facility’s policy, 4-07-01, “Facility Emergency Management Plan.” V0457 for the facility’s policy 3-02-19 “MOLST Form” V0502 for the facility’s policy 1-03-07, “New Patient Pre-Treatment Evaluation” V0516 for the facility’s policy 1-14-01, “Patient Assessment and Plan of Care” V0517 for the facility’s policy 1-14-01, “Patient Assessment and Plan of Care” V0550 for the facility’s policy 1-04-01E, “Arteriovenous Fistula or Graft Cannulation” V0628 for the facility’s policy 1-14-06, “Continuous Quality Improvement Program””

“GOV-RESPONDS TO NW REQUEST/WORKS TOWARD GOALS CFR(s): 494.180(i) The governing body receives and acts upon recommendations from the ESRD network. The dialysis facility must cooperate with the ESRD network designated for its geographic area, in fulfilling the terms of the Network’s current statement of work. Each facility must participate in ESRD network activities and pursue network goals. This Standard is not met as evidenced by: 44367 Based on interviews with the Facility Administartor and documentation from the ESRD Network 5, the facility adminstration failed to comply with the ESRD network monthy communication during the time frames provided. This failure placed the patients at risk for ineffective care . Findings include: Review on 03/11/2024 of the correspondence from the ESRD Network 5 (Network) determined that the facility received “ESRD Quality Improvement Report”, which contained facility specific outcomes and expectations for improvement. According to the Network, the facility is required to respond every month when report is received; however, the facility has not responded. On 03/11/2024, during an interview with the Facility Administrator (FA), the FA corroborated that he/she does receive the “ESRD Quality Improvement Report”, but has not responded to the Network.”