Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 012500	(X3) Date Survey Completed 09/16/2021
Name of Provider or Supplier Fmc Capitol City	Street Address, City, State 255 South Jackson Street, Montgomery, AL
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.

(X4) ID Prefix Tag

Summary Statement of Deficiencies

(Each deficiency should be preceded by full regulatory or LSC identifying information)

V0634

QAPI-INDICATOR-MEDICAL INJURIES/ERRORS
CFR(s): 494.110(a)(2)(vi)

The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification.

This STANDARD is not met as evidenced by:
Based on observation, facility policy and staff interviews, it was determined the facility failed to ensure staff reported, and documented an adverse event per facility policy. This affected Patient Identifier (PI) # 18, in 1 of 2 patient care observations conducted for AVF/AVG (arteriovenous fistula/graft) treatment initiation and had the potential to negatively affect all patients who dialyzed at the facility. Findings include: Facility Policy: Patient Adverse Event Reporting and Documentation Published: 01/02/2019 Version: 3 Purpose: The purpose of this policy is to provide guidelines for all clinical staff on reporting and documentation of patient related adverse events, serious adverse events, near misses and unsafe conditions to: - Promote a culture of safety. - Provide a standardized process for the identification and management of all patient related safety events ... Policy: Any time an adverse event (AE) or serious adverse event (SAE) occurs, staff are required to report, document, and review the event as indicated within this policy. All staff are responsible for timely completion of the policy requirements. Reporting: All employees are required to immediately report both AEs and SAEs to their supervising manager... Documentation: All adverse or SAEs shall be documented in the following: - Patient medical record - Adverse Event Data Entry Site ... Documentation of patient safety events: - Shall be factual, complete and concise. - Shall include patient assessment and represent an accurate recording of the events, times, interventions and result of interventions. 1. On 9/14/21 at 10:00 AM at station 17, EI (Employee Identifier) # 5, Patient Care Technician, initiated dialysis treatment for a 2 K (Potassium) 2.5 Ca (calcium) dialysis bath. At 10:37 AM EI # 5 placed a jug bath labeled 3 K 2.5 Ca at the base of the dialysis machine at station 19 for PI # 18. The surveyor asked EI # 5 why the dialysis bath was changed? EI #5 stated, "I just looked at the orders and this is the bath ordered". EI # 5 failed to test the dialysate pH when the bath acid concentrate was changed from 2 K to 3 K. In an interview on 9/16/21 at 8:25 AM with EI # 1, Clinic Manager, the surveyor requested documentation for AEs/near misses reported for 9/14/21. EI # 1 reported no AEs/near miss documentation was completed on 9/14/21. The surveyor reported the 9/14/21 10:00 AM observation at station 17 and the interview with EI # 5. EI # 1 confirmed EI # 5 failed to follow facility policy and test the dialysate pH when the bath acid concentration was changed and failed to complete AE event documentation for treatment initiation with an incorrect dialysis bath.