Fkc Christiana

“CFC-MEDICAL RECORDS CFR(s): 494.170 This Condition is not met as evidenced by: 27438 Based on observation, staff interviews, along with the review of facility policy, procedures and documents, it was determined that the facility failed to meet the Condition for Coverage (CfC) for V725 when it failed to ensure the security and protection of all patient information. The cumulative effects of systemic failures prevented the facility from having patient medical record security and privacy precautions in place to ensure patient protection and potentially put all 89 in-center dialysis patients at risk of unauthorized use of their information. Findings include: Based on observation, staff interviews, and policy review, it was determined that the facility failed to ensure that the staff maintained medical record protection as required by the regulations and facility policy for one out of three days observed (02/03/2025). (Refer to V727).”

“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: 27438 Based on observation and staff interview, it was determined that the facility failed to ensure emergency supplies were accessible for immediate use for three out of three treatment days. The failure to ensure immediate accessibility of emergency supplies could result in a delay in staff response during an emergency. This deficient practice had the potential to affect all 89 in-center dialysis patients receiving treatment at this facility. Findings include: Observation of the Emergency Code Cart for in-center patients (provides portable ready to use emergency supplies/medications) on 02/04/25 at 5:10 PM, revealed a four wheeled cart with three pull out drawers and one lift and slide door for the lower storage area. During the observation of the contents of the cart, it was noted that the second and third drawers were difficult to open due to crammed supplies within each drawer. The third drawer then became fully jammed and was unable to be closed with supplies protruding within and under the jammed drawers, and the bottom slide door would not open for the storage area. The jammed open drawers and closed bottom door made the Emergency Code Cart unusable at that time. The Charge Nurse was made aware and he/she attempted to close the cart drawer for seven minutes before rearranging and removing items in order to successfully close and then re-lock the cart. During an interview with the Charge Nurse on 02/04/24 at 5:20 PM, he/she confirmed that the Emergency Code Cart was excessively full and had both evacuation and emergency supplies for all 20 dialysis station patients within one cart. The Charge Nurse verified that the facility had created an evacuation container on wheels with supplies for the 20 dialysis station patients separate from the Emergency Code Cart, but the facility had continued to keep the supplies in both the Emergency Code Cart and the evacuation container which caused the Emergency Code Cart to become difficult to open and close.”

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 27438 Based on observation, staff interviews, and policy review, it was determined that facility staff failed to observe, recognize and change a wet transducer protector (used in the hemodialysis bloodlines as a protector to keep the blood side of the line separate from the machine side) immediately for one out of three treatment days. Failure to immediately change the wet transducer protector had the potential to contaminate the dialysis machine creating a direct medium for cross contamination during hemodialysis and could expose all 89 in-center dialysis patients receiving treatments at this facility. Findings include: Review of facility policy “Maintenance of Transducer Protectors” published November 7, 2022, revealed, “...The transducer protectors must be dry to provide accurate venous and arterial pressures...Cross contamination can occur if the internal transducer becomes contaminated with blood and is not disinfected or changed before the machine is used on another patient...The transducer protector must be changed immediately when contaminated with saline or blood...” 1. Observation on 02/03/25 from 9:45 AM until 9:55 AM of an unidentified patient receiving treatment at Station 15 revealed the transducer protector was noted to be wet and discolored pink. Licensed Practical Nurse (LPN)1 was observed standing at Station 15 at 9:50 AM making patient observations and entering documentation however LPN1 failed to observe, recognize and change the wet transducer during his/her patient observations. During an interview on 02/03/25 at 10:10 AM, LPN1 verified the wet transducer and verified wet transducers should be checked and changed if needed during patient observation to prevent the dialysis machine from blood contamination. During the interview, LPN1 was unable verify the facility policy on changing transducers stating, “I know they need to be changed but I’m not sure if changing the arterial transducer (prior to blood pump) would put air in the line.” 2. Observation on 02/03/25 from 9:55 AM until 10:05 AM of Patient (P)8 receiving treatment at Station 20 revealed the transducer protector was noted to be wet and discolored pink. The Charge Nurse was observed standing at Station 20 at 10:00 AM making patient observations and entering documentation, however, the Charge Nurse failed to observe and change the wet transducer during his/her patient observations. During an interview on 02/03/25 at 10:05 AM, the Charge Nurse verified the wet transducer and verified wet transducers should be checked and changed if needed during patient observation to prevent the dialysis machine from blood contamination. The Charge Nurse did verify the facility policy on transducer observations.”

“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: 27438 Based on observation, staff interviews, and policy review, it was determined that the facility failed to restrict access to the water purification room to only authorized users for two out of three treatment days. Failure to restrict access to the water purification room to only authorized users who were responsible for monitoring and maintaining the water purification, had the potential to negatively impact the safety and well-being of the 89 in-center dialysis patients receiving treatments at this facility. Findings include: Review of facility policy “Physical Security and Facility Access,” published September 5, 2023, revealed, “...Restricted access must be maintained to prevent unwanted tampering with the water equipment...” During the flash tour observation on 02/03/25 at 9:40 AM, the Administrative Assistant (AA) used a four-digit keyless security code to unlock the door in order to leave the patient waiting area and enter the locked door to the patient treatment room. Upon leaving the treatment room, the AA used the same four-digit keyless security code to enter the designated water purification system room/clean supply area (a wall without a door separates both areas). The AA confirmed at that time that the same four-digit keyless security code opened both the entrance to the treatment room and the water purification system room/clean supply room door. During an interview on 02/03/25 at 10:20 AM, the Biomedical Technician confirmed the security door to the water purification system/clean supply area should be programed differently than the entrance to the treatment room. During an interview on 02/03/25 at 10:30 AM, the Area Technical Operations Manager confirmed he/she was not aware of the facility security door to the water purification system/clean supply and the treatment door from the waiting area were programmed with the same code. The Area Technical Operations Manager verified the water purification system/clean supply area should be programmed differently than the entrance to the treatment room.”

“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: 27438 Based on observations, staff interviews, policy/procedure review, and review of the manufacturer’s directions for use (DFU), it was determined that facility staff failed to follow the manufacturer’s DFU, failed to remove expired supplies from the facility’s inventory, and failed to maintain or remove defective equipment for three out of three treatment days. Failure to follow the manufacturer’s DFU, failure to remove expired supplies and failure to service and remove equipment in need of maintenance or repair had the potential to negatively impact the safety and wellbeing of the 89 in-center dialysis patients receiving treatments at this facility. Findings include: Review of facility policy “Total Hardness Testing with SteriChek Sensitive Low-Range Water Hardness Test Strip Procedure” published September 3, 2024, revealed, “...Test strips will be used in accordance with the manufacturer’s instructions for use unless otherwise stated in this procedure ... Inspect test strip bottle and verify strips are not expired (expires after 6-month of opening)...” Review of facility policy “Equipment Installation - Operation - Maintenance - Repair - and Disposal” published July 6, 2021, revealed, “...This policy applies to...Medical Equipment...Dialysis Chairs...Any equipment or device that is not fully functioning in accordance with IFU (Instructions for Use) or company policy, must be repaired or replaced as soon as reasonably possible. If the faulty equipment poses a risk to the patient or staff, the device will be immediately removed from service...” 1.Observation on 02/03/25 at 9:40 AM with Biomedical Technician of the Water Purification Room revealed the following expired supplies; two Hach-SteriChek Sensitive Water Hardness (used to check dissolved minerals in water) with expiration date of 12/24 printed on the container (written on bottle as opened on 01/24/25, which was after the expiration date), and an unopened bottle with expiration date of 05/24. During an interview on 02/03/25 at 9:45 AM, the Biomedical Technician verified the expired supplies in the water room should be removed and disposed of when past the expiration date. 2.Observations conducted on 02/03/25 from 9:50 AM until 10:20 AM of the 23 dialysis machines. Observation of the Technical Maintenance Room revealed three out of three dialysis machines, flagged as ready to use, with white raised staining noted across the front lower panel and bottom shelf of the machines. This staining/residue left the machines with an abrasive texture on the panels. Further observation of the dialysis machines located at Stations 1 through 20 revealed all 20 dialysis machines with the same white abrasive texture. During an interview on 02/03/25 at 9:45 AM, the Biomedical Technician verified that other facilities remove the staining/residue on the machine panels. The biomedical technician stated, “It can be scrubbed off but it’s difficult and eventually they are back looking the same if not often cleaned.” 3. Observations on 02/03/25 from 4:50 PM through 5:45 PM of all 21 treatment chairs (patients had all left for the day which provided full observation) revealed that 13 of the 21 treatment chairs had either multiple cracks on the arm rest covers and/or seat covers, which impaired disinfection of the chair between patients, and that 11 of the 21 of the treatment chairs had seat and/or back cushions that sagged. During an interview on 02/04/25 at 5:20 PM, Patient Care Technician (PCT)1 verified that patients have complained about the uncomfortable treatment chairs and are encouraged to bring cushions from home. During an interview on 02/04/25 at 5:00 PM, the Charge Nurse verified that the disinfection of the treatment chairs was an issue due to the treatment chairs having multiple cracks on the arm rests and/or seats. During an interview on 02/04/25 at 10:45 AM, Patient (P)1 verified the uncomfortable treatment chairs stating he/she brings a pillow from home to sit on. During an interview on 02/04/25 at 11:30 AM, the Medical Director verified that the dialysis machines should be maintained free of residue, and the treatment chairs should be free of defects and have the ability to be completely disinfected.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 27438 Based on record reviews, interviews, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider to meet adequacy (measures how well the dialysis is working) goals for two of seven in-center patients (Patient (P)5 and P6. Failure to follow the medical providers dialysis prescription or documentation of reason not followed, had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for all 89 patients receiving in-center dialysis treatments at this facility. Findings include: Review of the facility’s policy titled, “Patient Assessment and Monitoring,” revised 05/01/2023, indicated, “During Treatment...Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes or per state regulations ...Check prescribed blood flow is being achieved, or reason is documented in the medical record if unable to meet prescribed blood flow. 1. Review of P5’s “Treatment Sheet” forms, found in the electronic medical record (EMR), revealed six of six printed “Treatment Sheet” forms from 01/20/25 through 02/03/25, indicated the following: On 01/20/25, the staff failed to follow the dialysis prescription Blood Flow Rate (BFR) of 400 milliliters per minute (ml/min) during the four-hour treatment the BFR remained at 300 ml/min. On 01/22/25, the staff failed to follow the dialysis prescription BFR of 400 ml/min when during the four-hour treatment the BFR remained at 300 ml/min. On 01/24/25, the staff failed to follow the dialysis prescription BFR of 400 ml/min when during the four-hour treatment the BFR remained at 300 ml/min. On 01/27/25, the staff failed to follow the dialysis prescription BFR of 400 ml/min when during the four-hour treatment the BFR remained at 300 ml/min. On 01/29/25, the staff failed to follow the dialysis prescription BFR of 400 ml/min when during the four-hour treatment the BFR remained at 300 ml/min. On 02/03/25, the staff failed to follow the dialysis prescription BFR of 400 ml/min when during the four-hour treatment the BFR remained at 300 ml/min. There was no documented rationale for the change to the prescribed BFR. 2. Review of P6’s “Treatment Sheet” forms, found in the EMR, revealed four of six printed “Treatment Sheet” forms from 01/21/25 through 02/03/25, indicated the following: On 01/23/25, the staff failed to follow the dialysis prescription BFR of 400 ml/min when during the four-hour treatment the BFR remained at 300 ml/min. On 01/28/25, the staff failed to follow the dialysis prescription BFR of 400 ml/min when during the four-hour treatment the BFR remained at 300 ml/min. On 01/30/25, the staff failed to follow the dialysis prescription BFR of 400 ml/min when during the four-hour treatment the BFR remained at 350 ml/min. On 02/01/25, the staff failed to follow the dialysis prescription BFR of 400 ml/min when during the four-hour treatment the BFR remained at 300 ml/min. There was no documented rationale for the change to the prescribed BFR. During an interview on 02/04/25 at 11:45 AM, the Medical Director verified that he/she expects the treatment prescription to be followed as ordered or expects staff to document the reason the prescription was not followed. During an interview on 02/05/25 at 1:20 PM, the Charge Nurse reviewed and verified the discrepancy between the prescription and machine generated “Treatment Sheet” forms for P5 and P6 and revealed that he/she expects staff to monitor and document the BFR findings every 30 minutes and all treatment prescriptions for patients to be followed or have documentation on why the prescription was not followed.”

“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: 27438 Based on staff interviews, policy review, and facility program review, it was determined that the facility failed to track all biomedical events in the Quality Improvement Performance Improvement (QAPI) program for one out of six months. The failure to monitor events created missed opportunities for performance improvement that could affect all 89 in-center dialysis patients. Findings include: Review of facility policy “Free Standing Apheresis Facility: Quality Assessment and Performance Improvement (QAPI) Plan,” published July 1, 2024, revealed, “... Quality Indicators are composed of objective and measurable criteria based on current knowledge and clinical experience and can be identified and monitored through ...Audit of logs...” Review of the facility QAPI meeting minutes on 02/04/2025 for six months from July 2024 thru December 2024 revealed biomedical staff had tracked and trended data which included the, “Post Worker Carbon Tank,” (removes chlorine from the water) log each month with the exception of December 2024. Review of December 2024 revealed the Biomedical Technician failed to include two dates (01/14/24 and 12/29/24) when errors occurred related to the “Post Worker Carbon Tank” log. During an interview on 02/04/25 at 10:40 AM, the Biomedical Technician verified the missing data for December 2024 in the QAPI meeting minutes. The Biomedical Technician stated he/she had tracked and trended issues related to the “Post Worker Carbon Tank,” log in previous meetings but had missed tracking data for December 2024. During an interview on 02/04/25 at 10:50 AM, the Area Technical Operations Manager verified the missing data in the December 2024 QAPI meeting minutes.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 27438 Based on observation, medical record review, policy review and staff interviews, it was determined that the facility failed to ensure safeguards were in place to protect patient medical records from unauthorized use as determined by the placement of unsecured medical records in a plastic open wall file holder outside a locked door in the patient waiting room for one out of three treatment days. Failure to follow safeguards to ensure the security of patient medical records, had the potential to negatively impact the privacy for all 89 in-center dialysis patients receiving treatments at this facility. Findings include: Review of facility policy “Confidentiality of Patient Information,” published May 6, 2024, revealed, “...The Contracted Entity must safeguard the medical record contents from unauthorized use and store the information in a secure location (paper and electronic) ...All PHI (Protected Health Information) will be physically safeguarded to protect against inappropriate or inadvertent disclosure to unauthorized individuals and inappropriate use by authorized individuals...” Observation conducted on 02/03/25 at 8:35 AM of the empty clinic (no patients or staff) waiting room. An introduction was made to the Administrative Assistant (AA) who was sitting in an office with a glass window which overlooked the waiting area. The AA left the office to inform the Charge Nurse of a surveyor entering the facility. Observation of the room revealed a single plastic clear gray wall file holder attached to the wall on the waiting room side of a locked door. The file holder contained the identifiable medical information for four separate patients (Patient (P)9, P10, P11, and P12). The medical information was in loose paper form, and it was stappled separately for each individual patient. The AA entered the waiting room with the Charge Nurse. During an interview on 02/03/05 at 8:45 AM, the Charge Nurse was given a brief explanation of the purpose of the survey. The surveyor then questioned the Charge Nurse about the unsecured patient information in the plastic file holder in the waiting room. The Charge Nurse opened the office door and stated this was his/her’s office and usually he/she has been able to retrieve any information in the file holder by this time of day, but he/she had been providing patient care. The Charge Nurse then retrieved the patient records form the wall file holder and placed them in his/her’s locked office. During an interview on 02/03/25 at 1:00 PM, the AA verified that he/she arrives at the clinic around 8:00 AM. The AA then stated that the facility’s routine was for him/her to retrieve any new faxes in the morning and then place the information for the Charge Nurse in the file holder outside the Charge Nurse’s office if the door is locked. The AA verified that the Charge Nurse’s door was locked this morning. The AA stated that the patients are not in the waiting area when he/she places the paperwork in the file holder, but the front door is always unlocked for entry. During an interview on 02/04/25 at 9:30 AM, the Facility Administrator stated he/she was covering the facility at this time because the former Facility Administrator recently vacated the position. The Facility Administrator stated he/she was unaware of the file holder usage outside the Charge Nurse’s office. The FA verified that the patient records should be kept secure and safe from unauthorized use. During an interview on 02/04/25 at 11:45 AM, the Medical Director stated he/she had been made aware of the medical record privacy issue on 02/03/25. The Medical Director verified that the patient records must be protected for privacy and security at all times.”