Fmc Dialysis Services of College

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 27438 Based on observation, interview, and policy review, the facility failed to ensure staff use dedicated clean sinks for hand washing only. The failure to maintain the designated clean sink, one of three survey days, for hand washing had the potential for cross contamination and could affect 144 in-center hemodialysis patients. Findings include: Observation on 01/09/24 at 9:05 AM, revealed one used 1,000 ml (milliliter) sodium chloride solution (used during dialysis treatment as fluid) and one bibag (flexible bag initially containing dry Bicarbonate which mixes with dialysis water during dialysis treatment) were draining in the sink designated by a “clean sink” sign. The sink was located near station 24. During an interview on 01/09/24 at 11:30 AM, the Patient Care Technician (PCT) 6 assigned to patients at station 24 verified sinks designated as “clean sinks” should never be used for draining dialysis equipment. During an interview on 01/10/24 at 10:55 AM, the Clinical Manager verified sinks designated as “clean sinks” should never be used for draining dialysis equipment. Request was made for the facility’s policy related to hand hygiene or clean sinks. The Facility Administrator was unable to provide a policy however the facility’s policy titled, “Dialysis Precautions,” revision date 01/04/12, indicated, “Approach ...all supplies and equipment used for a patient’s treatment, they are contaminated ... Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handled or stored.””

“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 interview, and review of the facility’s policy, the facility staff failed to observe transducer protectors (used in the hemodialysis bloodlines as a protector to keep the blood side of the line separate from the machine side) immediately when wetted. Failure to immediately remove and visualize the machine side of a wetted external transducer protector had the potential to contaminate the dialysis machine creating a direct medium for cross contamination and could expose all 144 in-center hemodialysis patients. Findings include: 1. Observation on 01/08/24 from 9:00 AM until 9:35 AM of an unidentified patient receiving treatment at Station 15 revealed the transducer protector was noted to be wet and discolored pink. The Patient Care Technician (PCT)7 was observed standing at Station 15 at 9:24 AM making patient observations and documentation but failed to observe and change the wet transducers during his/her patient observations. During an interview on 01/08/24 at 9:35 AM, the PCT7 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. 2. Observation on 01/08/24 from 11:25 AM until 12:00 PM of an unidentified patient receiving treatment at Station 2 revealed the transducer protector was noted to be wet and discolored pink. The PCT4 was observed standing at Station 2 at 11:55 AM making patient observations and documentation but failed to observe and change the wet transducers during his/her patient observations. During an interview on 01/08/24 at 12:05 AM, the PCT4 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 an interview on 01/10/24 at 10:55 AM, the Clinical Manager verified wet transducers should be checked by staff and changed if needed during patient observation or anytime observed during treatment to prevent the dialysis machine from blood contamination. Review of the facility’s policy titled, “Maintenance of Transducer Protectors” revised 11/07/2022, indicated, “The transducer protector must be changed immediately when contaminated with saline or blood.””

“IC-HBV-TEST PTS/STAFF POST LAST DOSE CFR(s): 494.30(a)(1)(i) Hepatitis B Screening: Patients and Staff Test all vaccines [patients and staff] for anti-HBs 1-2 months after last primary vaccine dose. -- If anti-HBs is <10 mIU/mL, consider patient or staff member susceptible, revaccinate with an additional three doses, and retest for anti-HBs. -- If anti-HBs are =10 mIU/mL, consider immune, and retest patients annually. -- Give booster dose of vaccine to patients if anti-HBs declines to <10 mIU/mL and continue to retest patients annually. This Standard is not met as evidenced by: 27438 Based on observation, interview, personnel medical file review, and policy review, the facility failed to ensure one of six sampled employees (Patient Care Technician (PCT) 6) hepatitis B (a serious liver infection) surface antiboby status (positive or reactive results indicate protection against hepatitis B virus) was verified upon hire when working with Hepatis B positive patients.. The failure to verify staff’s Hepatitis B surface antibody status, in a timely manner. This had the potential for a possible exposure to Hepatitis B. Findings include: Observation of the isolation room on 01/08/24 at 10:30 AM revealed PCT6 providing care to an unidentified Hepatitis B positive patient. Review of PCT6’s personnel medical file revealed he/she had been hired on 02/21/22. The facility had failed to verify the employee’s Hepatitis B surface antibody (a protective response to the hepatitis B infection) to determine the employee’s immune status. During an interview on 01/11/24 at 10:55 AM, the Clinical Manager confirmed employee PCT6’s personnel medical file was missing the required Hepatitis B test surface antibody results. Review of the facility’s policy titled, “Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+),” dated 11/06/2023, indicated, “Make patient/staff assignments to reflect patient and staff hepatitis antibody and antigen status.””

“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: 27438 Based on observation, interview, and review of the facility’s policy, the facility failed to ensure that staff followed the medication labeling policy. This deficient practice had the potential to affect the potency of the medication and could affect all 144 in-center hemodialysis patients receiving treatment at this facility. Findings include: Observation of the facility’s medication preparation area on 01/08/24 at 11:40 AM showed the following open injectable medications without the date, time, and initials of staff: one multi use vial of Lidocaine HCL 1% (local injection to cause numbness), without staff initials, date, and time the vial was opened, one vial of Heparin 30,000 units (measurement of medications action) in 30 milliliter (ml)measurement of volume) without initials, date, and time the vial was opened by staff. In addition, the following oral medication without a date, time, and initials of staff: Cinacalcet Hydrochloride tabs (used to treat elevated levels of calcium in the blood), without staff initials, date, and time the bottle was opened. During an interview on 01/08/24 at 11:55 AM, the Charge Nurse stated the nursing and Patient Care Technician (PCT) staff are required to date, time, and initial all multi dose medications when opened. A review of the facility’s policy titled, “Medication Preparation and Administration,” revised 02/06/2023, indicated, “When preparing medications if the vial is not used immediately in its entirety, the nurse or PCT (if allowed by state regulations), must place the date and time the vial was opened on the medication label along with their initials.””

“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, interview, and manufacturer’s directions for use (DFU) review, the facility failed to follow the manufacturer’s DFU and remove expired supplies from the facility’s inventory. This had the potential for staff to use supplies no longer viable and negatively impact the safety and wellbeing of the 144 patients receiving in-center hemodialysis treatments at this facility. Findings include: 1. Observation on 01/08/24 at 12:30 PM of the Water Room (dedicated, secured, and access-controlled room that provides source water for dialysis) revealed the following expired equipment; one Minncare Residual Test Strips (used to test dialysis equipment after disinfection) with an expiration date of 12/19/23 printed on the container, and a Mesa Labs Standard Buffer Solution 4.00 pH (used for calibration of conductivity meters) with an expiration date of 2023-10-26 printed on the bottle. During an interview on 01/08/24 at 3:45 PM, the Biomedical Technician verified the expired supplies in the water room are to be removed and disposed of when expired. 2. Observation on 01/09/24 at 3:00 PM of the laboratory supply area revealed one unopened box of Blood Glucose Test Strips. The box of 25 test strips had an expiration date of 12/21/23 printed on the box and were found in the cabinet with unexpired supplies. During an interview on 01/09/24 at 3:15 PM, the Clinical Manager stated the expired supplies are to be removed and disposed of when expired. Review of the facility’s policy titled, “Storage of Supplies,” revision date 04/05/21, indicated, “Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired, contaminated or damaged ...Supplies must be rotated First in-First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date.””

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- (1) At least annually for stable patients; This Standard is not met as evidenced by: 28297 Based on interview, record review, and review of facility policy, the facility failed to develop an annual assessment and plan of care for one of 10 sampled (Patients (P) 6). The failure to develop an assessment and plan of care timely had the potential for missed opportunities for improved care and could affect 144 in-center patients. Findings include: Review of the “Face Sheet” located in the hard chart revealed P6 was admitted to the facility on 07/23/21 with a diagnosis of end stage renal disease (ESRD). Review of the 90-day “Assessment” and “Plan of Care” provided by the facility was dated 01/03/22. However, the next annual “Assessment” and “Plan of Care” was not developed until 07/19/23, more than six months late. During an interview on 01/09/24 at 3:00 PM the Dietician confirmed P6’s “Assessment and “Plan of Care” was late. He/She stated they usually do the annual assessment and plan of care during the admission month and P6 should have had an annual assessment in July of 2022 and then it would have been on schedule. The Dietician stated it was important to do assessments and plan of care timely to ensure patients are involved in their care. Review of the facility policy “Comprehensive Interdisciplinary Assessment and Plan of Care,” revised 07/03/23 revealed the following: “ ...Comprehensive interdisciplinary assessments and modifications to the Plan of Care must be conducted 12 months after the completion of the 3 month assessment and then reassessed annually thereafter on all stable patients ...””

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 27438 28297 Based on interview, record review, and review of facility policy, the facility failed to ensure nine of 10 (Patients (P) 1, P3, P4, P5, P6, P7, P8, P9 and P10) were given the opportunity to attend and participate in their Plan of Care (POC). The failure to give patients opportunities to be involved in their POC had the potential for missed opportunities for improved care. Findings include: 1.Review of the “Face Sheet “located in the hard chart for P1 revealed the facility admitted the patient on 01/24/23 with a diagnosis of end stage renal disease (ESRD). Review of P1’s unstable “POC” was provided by the facility dated 11/29/23 and 12/20/23. However, there was no invitation with the meeting date to the “POC” and the patient did not sign off on the “POC” to indicate the patient participated in the “POC.” 2.Review of the “Face Sheet” located in the hard chart revealed P3 was admitted to the facility on 10/30/23 with a diagnosis of ESRD. Review of P3’s “POC” dated 11/29/23, was provided by the facility. However, there was no invitation with the meeting date to the “POC” and the patient did not sign off on the “POC” that would indicate the patient participated in the “POC.” 3.Review of the “Face Sheet located in the hard chart revealed P4 was admitted to the facility on 10/11/23 with a diagnosis of ESRD. Review of P4’s “POC” dated 11/29/23, was provided by the facility. However, there was no invitation with the meeting date to the POC and the patient did not sign off on “POC” that would indicate the patient participated in the “POC.” 4. Review of the “Face Sheet” located in the hard chart revealed P5 was admitted to the facility on 04/06/23 with a diagnosis of ESRD. Review of P5’s initial “POC” dated 04/24/23 and a 90-day “POC” dated 07/25/23 was provided by the facility. However, there was no invitation with the meeting date to the “POC” and the patient did not sign off on either “POC” that would indicate the patient participated in the “POC.” 5.Review of the “Face Sheet” located in the hard chart revealed P6 was admitted to the facility on 07/23/21 with a diagnosis of ESRD. Review of P6’s 90 day “POC” dated 01/03/22 and annual “POC” dated 01/03/23 was provided by the facility. However, there was no invitation for 01/03/22 “POC” and the annual “POC” was signed off on 08/02/23, two weeks after the meeting date. The patient did not sign off on either “POC” that would indicate the patient participated in the “POC.” 6. Review of the “Face Sheet” located in the hard chart revealed P7 was admitted to the facility on 09/22/23 with a diagnosis of ESRD. Review of the initial “POC” dated 10/18/23 was provided by the facility. However, there was no invitation with the meeting date to the “POC” meeting and the patient did not sign off on the “POC” that would indicate the patient participated in the “POC.” 7. Review of the “Face Sheet” located in the hard chart revealed P8 was admitted to the facility on 01/10/22 with a diagnosis of ESRD. Review of the stable “POC” dated 01/25/23 was provided by the facility. However, there was no invitation with the meeting date to the “POC” and the patient did not sign off on the “POC” that would indicate the patient participated in the “POC.” 8. Review of the “Face Sheet” located in the hard chart revealed P9 was admitted to the facility on 01/06/23 with a diagnosis of ESRD. The stable “POC” dated 04/25/23 was provided by the facility. However, there was no invitation with the meeting date to the “POC” that would indicate the patient signed off on the “POC” or participated in the “POC.” 9. Review of the “Face Sheet” located in the hard chart revealed P10 was admitted to the facility on 08/08/23 with a diagnosis of ESRD. The stable “POC” dated 08/30/23 was provided by the facility. However, the patient did not sign off on the “POC” that would indicate the patient participated in the “POC.” During an interview on 01/09/24 at 3:00 PM the Dietitian stated the process for the “POC” and invitations was that each month during the POC meeting held in the conference room the next month’s meeting date is set up with the Physician. Once the date is established, I will go in and print out the invitations for the patients and give them to the charge nurse to get the patient to sign to determine how the patient wants to participate. The floor staff will help with getting patients to sign invitations. After the patient has signed the invitation, it will be filed in the patient’s chart. After the POC meeting has taken place, the Dietician will print out the completed plan of care and give it to the charge nurse to go over with the patient to get it signed. The Dietician confirmed P6 invitation was not checked on how the patient wanted to participate in the POC meeting, and it wasn’t signed off until two weeks after the POC meeting date. The Dietician also confirmed that nine of 10 sampled patients POC’s were not signed off by the patients. He/she stated it was important for patients to be involved in the outcome of their care.” During an interview on 01/09/24 at 3:30 PM the Charge Nurse stated he/she was unable to find any of the invitations or POC’s for sampled patients and that they were responsible for getting invitations signed and POC signed after the meeting. During an interview with the Medical Director on 01/10/24 at 9:45 AM he/she stated we must have a time established at the POC meeting for patients to be a part of the meeting and should be invited and involved in their care. During an interview on 01/10/24 at 10:30 AM the Clinical Manager stated Nursing Staff were responsible for getting the patient to sign the invitation and sign the POC after the meeting has taken place and that he/she understands that is not happening. The Clinical Manager stated it was important to engage the patient and involve them in their care. d POC/s signed. Review of the facility policy Comprehensive Interdisciplinary Assessment and Plan of Care, revised 07/03/23 revealed the following: “ ...Patient Participation in Plan of Care The following are recommendations for involving the patient in the development and review of the plan of care: ...Encourage both patient and family to participate IN THE Plan of care discussions in whatever format the facility and attending physician develop. Notify the patient inwriting of the time and date of the Plan of care review ...If the patient and or designee is unable or unwilling to attend the Plan of Care meeting ...the Registered Nurse may review the Plan of care as developed by the IDT at the meeting with the patient and obtain the patients’ signature and any comments. The patients’ level of participation is determined by the patients ...””