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 013422 (X3) Date Survey Completed 01/03/2024
Name of Provider or Supplier Ochsner Health Center-Butler Street Address, City, State 1404 E Pushmataha Street, Butler, 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)
E0000 An onsite recertification survey was conducted at Ochsner Health Center-Butler from 1/2/24 to 1/3/24. The clinic was in substantial compliance with the Conditions of Participation for Emergency Preparedness.
J0000 A recertification survey was conducted at Ochsner Health Center-Butler from 1/2/24 to 1/3/24. Standard level deficiencies were cited and will require a Plan of Correction.
J0043 PHYSICAL PLANT AND ENVIRONMENT

The clinic . . . has a preventive maintenance program to ensure that: 491.6(b)(2) Drugs and biologicals are appropriately stored; and


This STANDARD is not met as evidenced by:
Based on observations, clinic policy/procedure, and interviews, it was determined the clinic failed to ensure opened multidose vials were not available for patient use beyond the expiration dates. This had the potential to affect all patients treated at this clinic. Findings included: Clinic Policy/Procedure: Medication Storage and Handling Policy Number: not documented Revised Date: 4/28/23 Medications and biologicals shall be stored to ensure their integrity, stability, and effectiveness... Handling of multi-dose medications in the RHC (Rural Health Clinic) will be as follows: ...3. Upon opening, the healthcare personnel will immediately write the following on the label: a. Date opened... Unless otherwise specified, all multi-dose medications should be discarded 28 days after opening, or at expiration date (whichever occurs first). Vaccines are discarded on expiration date... 1. An observation of the medication storage area was conducted on 1/2/24 at 11:00 AM with Employee Identifier (EI) # 4, Licensed Practical Nurse (LPN). In the medication storage cabinet, the surveyor observed one Dexamethasone 30 milliliter multidose vial with a label indicating the vial was opened on 11/13/23. Per clinic policy, the opened multidose vial should have been discarded after 28 days on 12/11/23. In an interview conducted on 1/3/24 at 2:00 PM, EI # 1, Manager, Clinic Operations, confirmed the clinic failed to ensure expired medications were not available for patient use.
J0044 PHYSICAL PLANT AND ENVIRONMENT

The clinic . . . has a preventive maintenance program to ensure that: 491.6(b)(3) The premises are clean and orderly.


This STANDARD is not met as evidenced by:
Based on observations, clinic policy/procedure, and interviews, it was determined the clinic failed to ensure sharps containers were accessible in all technical work areas. This had the potential to affect all patients and staff at this clinic. Findings include: Clinic Policy/Procedure: Section S Blood Borne Pathogen Policy and Exposure Control Plan Policy Number: not documented Policy Date: 1/19 Purpose: To establish responsibilities and procedures for protecting patients and personnel from blood borne pathogens...through contact with blood and body fluids. ...A. Methods of Compliance ...3. Contaminated sharps shall be placed in appropriate puncture resistant, leak-proof containers...Contaminated sharps containers shall be easily accessible to employees... Engineering Controls ...Sharps containers are to be kept in an upright position in readily accessible locations in the clinic. ...Containers are constructed in a manner to prevent spillage or protrusion of contents. They are color coded and closable... Clinic Policy/Procedure: Clinic Laboratory Procedures Policy Number: not documented Policy Date: 1/19 The following policies and procedures apply when a patient has lab work performed and/or blood drawn for a lab procedure: ...14. Disposal of Specimens and Contaminated Materials: ...a. Tubes...with blood or serum should be placed in the sharps safety disposable containers in the technical work area. ...b. Dispose of needles, syringes, and blades only in sharps safety disposable containers designated for used hypodermic equipment... 1. An observation of the staff performing a venipuncture for the purpose of obtaining a laboratory blood sample was conducted on 1/3/24 at 8:25 AM. Employee Identifier (EI) # 8, Laboratory Technician, escorted an unsampled patient to the lab sampling room which contained a chair and a small table. There was no sharps container visible in the room. EI # 8 placed the portable venipuncture tray on the table, donned gloves, prepped the site of the unsampled patient and performed the venipuncture with a vacutainer needle. After obtaining the blood sample via venipuncture, EI # 8, placed the contaminated needle and vacutainer tubing in the portable venipuncture tray. EI # 8 then walked down the hall approximately 20 feet to the laboratory and discarded the used needle and tubing in the sharps container. In an interview conducted on 1/3/24 at 8:50 AM, EI # 1, Manager, Clinical Services, confirmed the clinic failed to have a sharps container accessible in the technical work area.
J0125 PROVISION OF SERVICES

491.9(b) Patient care policies. (3) The policies include: (iii) Rules for the storage, handling, and administration of drugs and biologicals.


This STANDARD is not met as evidenced by:
Based on observations, clinic policy and procedure, and interviews with staff, it was determined the clinic failed to ensure expired medical supplies and laboratory testing supplies were not available for patient use and failed to ensure the staff disinfected the medication vial septum prior to piercing with a needle when preparing injectable medications. This had the potential to affect all patients treated at this clinic. Findings include: Clinic Policy/Procedure: Medication Storage and Handling Policy Number: not documented Revised Date: 4/28/23 ...Single-dose vials of medications should be prepared in a RHC (Rural Health Clinic) in the following way: 1. Parental medications should be accessed in an aseptic manner...and the rubber septum should be disinfected with alcohol prior to piercing... 1. A tour of the laboratory testing room was conducted on 1/2/24 at 10:30 AM with Employee Identifier (EI) # 5, Radiology/Lab Technician. Located in the urine sample kit drawer were four Cobas PCR (brand name) Urine Sample Kits with an expiration date of 10/31/23 on each. 2. A tour of the patient treatment halls was conducted on 1/2/24 at 11:00 AM. In Exam Room # 3 the following out of date supplies were observed and available for patient use: Povidine Iodine four fluid ounce bottle with an expiration date of 7/21. Two Hibiclens four fluid ounce bottles with an expiration date 5/23 on each. Five Culture swab kits with an expiration date of 1/31/23 on each. In the medication storage area drawer, the surveyor observed the following: 13 Hemocult test strips in packets of three containting 39 test strips. Each test strip had an expiration date of 7/22. Hemocult developer 15 millimeters bottle with an expiration date of 9/23. In an interview conducted on 1/3/24 at 2:00 PM, EI # 1, Manager of Clinical Operations, confirmed the clinic failed to ensure out of date supplies were not available for patient use. 3. An observation of medication administration was conducted on 1/3/24 at 8:58 AM. EI # 7, Licensed Practical Nurse (LPN), removed the cap from a single dose vial of Toradol 60 mg (milligrams) then pierced the septum with the syringe needle and withdrew the medication. EI # 7 failed to disinfect the septum with alcohol prior to piercing. In an interview conducted on 1/3/24 at 2:00 PM, EI # 1 confirmed the staff failed to follow the clinic policy and disinfect the septum with alcohol.