Davita Durango Dialysis Center

“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: 46675 Based on observations, document review, and interviews, the facility failed to ensure medical supplies had not expired and were unavailable for patient use in two of three supply storage areas and in the evacuation cart. Findings include: Facility policy: The Infection Control For Dialysis Facilities policy read, supplies will be stored in a manner that maintains their integrity. 1. The facility failed to ensure expired medical supplies were discarded and not available for patient use. a. On 11/6/23 at 1:47 p.m., observations of the peritoneal dialysis (PD) training and exam room revealed three pairs of size 6.5 sterile gloves, expired on 9/27/20. b. On 11/6/23 at 4:08 p.m., an observation of the code cart (cart on wheels containing emergency medications and supplies that can be brought to the site of a medical emergency for life support) revealed the following expired medical supplies: i. Two 10 ml luer lock syringes expired on 3/31/23. ii. Two blood assembly connectors with male luer lock (a device used to collect blood) expired on 12/10/22. c. On 11/7/23 at 12:15 p.m., an observation of the evacuation cart revealed the following expired medical supplies: i. Two boxes of 100 povidone-iodine prep pads expired on 8/2021. ii. Two bottles of hand sanitizer gel expired on 11/2021. iii. Four 17 gauge arterial and venous fistula needle sets (needles used to perform dialysis treatments) expired on 2/13/23. iv. One 17 gauge arterial and venous fistula needle set expired on 4/20/23. v. Four 17 gauge arterial and venous fistula needle sets expired on 9/24/23. vi. Nineteen 10 ml luer lock syringes expired on 5/31/22. vii. Ten 10 ml luer lock syringes expired on 8/31/22. d. On 11/8/23 at 8:00 a.m., an interview was conducted with PD registered nurse (RN) #3. RN #3 stated both PD nurses were expected to check for outdated supplies in the PD exam and training room prior to use to ensure expired medical supplies were not available for patient use. RN #3 stated the facility had no documented formal process in place to monitor medical supplies in the PD exam and training room or other areas in the facility for expiration date. RN #3 stated it was important to monitor medical supplies for expiration date to prevent infections and the patient was at risk for infection if expired medical supplies were used for patient care. e. On 11/8/23 at 9:20 a.m., an interview was conducted with certified clinical hemodialysis technician (CCHT) #4. CCHT #4 stated medical supplies were rotated when new supplies were received. CCHT #4 stated the facility had no documented formal process in place to monitor medical supplies for expiration date. CCHT #4 stated expired medical supplies were not to be used in patient care because the supply might become defective and not work as intended after the expiration date. CCHT #4 stated the patient was at risk for infection if expired medical supplies were used in patient care. f. On 11/8/23 at 10:09 a.m., an interview was conducted with registered nurse (RN) #5. RN #5 stated the facility did not have a formal process for monitoring medical supplies on the treatment floor or storage area for expiration dates. RN #5 stated expired medical supplies had the potential to break down and placed the patient at risk for developing an adverse reaction to the specific supply if used in patient care. g. On 11/8/23 at 10:29 a.m., an interview was conducted with facility administrator (Administrator) #2. Administrator #2 stated audits were completed monthly to monitor for expired supplies, however, they were not documented. Administrator #2 stated there was no formal process for checking for outdated medical supplies on the treatment floor or in the supply room. Administrator #2 stated she documented monthly audits of the code cart for outdated supplies and the administrative assistant checked the evacuation cart monthly. Administrator #2 stated the risk of using expired medical supplies in patient care was possible blood loss or an adverse reaction during treatment. This was in contrast to The Infection Control For Dialysis Facilities policy which read, supplies were to be stored in a manner that maintained their integrity.”

“GOV-GB INFORMS MED STAFF OF P&P/QAPI PROG CFR(s): 494.180(c)(2),(3) The governing body- (2) Ensures that all medical staff who provide care in the facility are informed of all facility policies and procedures, including the facility’s quality assessment and performance improvement program specified in §494.110. (3) Communicates expectations to the medical staff regarding staff participation in improving the quality of medical care provided to facility patients. This Standard is not met as evidenced by: 46675 Based on interviews and document review, the facility failed to ensure the medical staff met regularly and maintained written records of their meetings. Findings include: Reference: The Medical Staff Bylaws read, the prerogatives of an attending staff member shall be to attend medical staff meetings. Each facility medical staff shall hold staff meetings as needed to address patient care needs, or more frequent meetings as required by state or local law. At each medical staff meeting, the medical director shall determine the order of business for that meeting, as required by state law. Where warranted, minutes of all meetings shall be prepared and shall include a record of attendance and the results of votes taken on each matter considered. Copies of minutes of a meeting of a facility medical staff shall be made available and maintained on file as appropriate. 1. The facility failed to ensure the medical staff met regularly and maintained written records of those meetings. A. Document review i. Upon request, the facility was unable to provide documentation of medical staff meetings and minutes from those meetings. This was in contrast to the Medical Staff Bylaws which read, staff members were to attend medical staff meetings. Each medical staff held staff meetings as needed to address patient care needs and as required by state law. Minutes of all meetings were prepared and included a record of attendance and the results of votes taken on each matter considered. Copies of minutes were made available and maintained on file. B. Interviews i. On 11/8/23 at 10:50 a.m., an interview was conducted with medical director (Director) #1. Director #1 stated he did not hold formal medical staff meetings with the other providers at the facility. He stated medical staff members communicated informally in person at the office as needed. Director #1 stated no meeting minutes were taken during informal communication between providers at the clinic. ii. On 11/8/23 at 10:29 a.m., an interview was conducted with facility administrator (Administrator) #2. Administrator #2 stated the providers communicated regularly about patient care in an informal manner but had not documented formal meetings or taken meeting minutes. Administrator #2 stated she knew patient care information was being communicated between providers, although no documentation of such could be provided. Administrator #2 stated the patient was at risk for compromised care if medical staff did not document communication from meetings about patient care. This was in contrast to the Medical Staff Bylaws which read, staff members were to attend medical staff meetings. Each medical staff held staff meetings as needed to address patient care needs and as required by state law. Minutes of all meetings were prepared and included a record of attendance and the results of votes taken on each matter considered. Copies of minutes were made available and maintained on file.”