Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 012501	(X3) Date Survey Completed 03/14/2019
Name of Provider or Supplier Gadsden Dialysis	Street Address, City, State 409 South First Street, Gadsden, 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 review of facility policy, observations, ABN (Alabama Board of Nursing) Standards of Nursing Practice, and interviews, it was determined the facility failed to ensure: 1) The RN (Registered Nurse) delegated tasks according to non-licensed staff scope of practice. 2) The RN stored, administered, and controlled all medications. 3) All open multidose medication vials were labeled. 4) Expired supplies and medications were discarded by the facility staff. This affected Patient Identifier (PI) # 5 and had the potential to affect all patients treated at the facility. **** Findings include: Facility Policy: Medication Policy Policy #: 1-06-01 Revision Date: June 2017 "Purpose: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. Policy: 1. The Administrator/designee is responsible for supervising, storing, administering, and controlling of medications and performs a monthly audit and inventory ... 7. Heparin, Lidocaine, and normal saline may be drawn up and administered by licensed nurse teammates and patient care technicians, if allowable by their state and they have met their state's educational requirements ... 11. ...Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate... 13. ...Do not use any ampule or vial that has been stored improperly or has expired... 22. Medications and needle/syringe storage are done in accordance with state regulations... 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... 29. All medications in the facility are checked monthly. Insulin and other medications with preservatives are dated and initialed once opened. All medications are checked monthly for expiration dates... 31. Disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment and inventory areas and disposed of per state/local regulations." ****** ABN (Alabama Board of Nursing) Chapter 610-X-6 Standards of Nursing Practice 610-X-6-.11 Assignment, Delegation And Supervision... 1. The registered nurse shall be accountable and responsible for the assignment of nursing activities and tasks to other health care workers based on, but not limited to: ...2. Assignments may not exceed the scope of an individual licensed nurse's scope of practice... 4. Tasks delegated to unlicensed assistive personnel may not include tasks that require: a. The exercise of independent nursing judgment or intervention. b. Invasive or sterile procedures. c. Assistance with medications... ****** 1. A tour of the treatment area and medication room was conducted on 3/12/19 at 9:15 AM by the surveyor. In the medication refrigerator, the surveyor observed the following: Tubersol, 10 test, 5 ml (Milliliter) opened vial. There was no label on the vial for the date opened, initials of the person who opened the vial and the date to be discarded. Humulin R (regular insulin) 10 ml vial with an opened date documented as 11/20/17. In the emergency cart, the surveyor observed the following: Normal Saline 0.9 % (percent) sodium chloride 1000 ml bag with an expiration date of 8/2018 - (24 bags) The surveyor observed Purell Instant Hand Sanitizer 354 ml bottle with an expiration date of 5/2018 located on the counter of the clean sink in the medication room. An interview was conducted on 3/14/19 at 10:30 AM with Employee Identifier (EI) # 1, Group Facility Administrator who confirmed the above findings. 2. During an observation of care on 3/13/19 at 10:23 AM, the surveyor observed EI # 4, RN, place the following medications on PI # 5 hemodialysis chairside table: 2 syringes filled with Hectorol totaling 4.5 mg (milligrams), and 1 syringe filled with Erythropoietin 10,000 units. EI # 4 walked away from the medications and returned at 10:54 AM to administer the medications. Further observation revealed EI # 5, Certified Clinical Hemodialysis Technician connected PI # 5's heparin syringe to the patient's venous needle line. EI # 4 returned to the patient's chairside and administered the heparin. EI # 5, assisted in the administration of heparin by removing the needle and cap from the heparin syringe and connecting the heparin to the patient's venous needle line. EI # 4 left the heparin unattended. EI # 4 failed to store medications as directed per facility policy. An interview was conducted on 3/14/19 at 10:30 AM with EI # 1, who confirmed the above findings.