Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391
Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 012508 (X3) Date Survey Completed 12/12/2019
Name of Provider or Supplier Birmingham East Dialysis Street Address, City, State 1105 East Park Drive, Birmingham, 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)
V0143 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:
Based on observations,review of facility policy, and interviews, it was determined the facility failed to ensure all expired medications were discarded by the facility staff. This had the potential to affect all patients dialyzed at the facility. Findings include: Facility Policy: Medication Policy Policy #: 1-06-01 Revision Date: April 2019 Purpose: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. Policy: ... 28. Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured), unless the manufacturer specifies a different (shorter or longer) date or as directed by the manufacturer as in the case of vaccines or state specific pharmacy regulations. Each vial is labeled with the initials of the person opening the vial and the expiration date... 1. During an observation of care conducted on 12/10/19 at 10:00 AM, the surveyor observed a multi-dose vial of Zofran 40 milliliter (ml) labeled with the open date of 10/1/19. The surveyor asked Employee Identifier (EI) # 3, Registered Nurse (RN), "How long can this vial of Zofran be used?" EI # 3, replied, "90 days." On 12/11/19 at 8:15 AM the surveyor asked EI # 10, RN, to open the medication drawer and the surveyor observed the same vial of Zofran 40 ml labeled with the open date of 10/1/19. The surveyor asked EI # 10, "How long can this vial of Zofran be used?" EI # 10 stated, "60 days." In an interview conducted on 12/11/19 at 9:00 AM, EI # 2, Manager Clinical Services, confirmed the staff lacked the knowledge of the facility policy for expired medications and failed to dispose of multi-dose vials with preservatives after 28 days.